Bundled green-MED diet × Eighteen-month MRS intrahepatic-fat reduction

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionHow are the selected question and the isolated-component question distinguished?Required	The selected existing question is 18-month intrahepatic-fat reduction from the bundled green-MED pattern, linked to its subclaim record. Liver-fat reduction from Mankai or green tea alone is preserved as context; no new split or verdict is created. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. Clinical independence and isolated-component effects have not been newly certified.	Selected question and verdict record, with parent and isolated-component boundaries	Research questions distinguishing bundled diets from individual components
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionHow are the original subclaim grade, note and absent values preserved?Required	Subclaim grade C and the note, weight-adjusted P=.035 versus conventional MED, are preserved. Subclaim score, status and axes are absent; parent C with 46 points and axes provide separate historical context. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. The selected subclaim score, status and axes are absent from the original.	Subclaim C and note, absent score, status and axes, and parent history	Records distinguishing additional evidence from preservation of the original grade
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionWhat was the actual study population?Required	The original research explanation records 294 adults with abdominal obesity or dyslipidemia. This is not recast as requiring both conditions together or as findings in every patient with liver disease. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. Exact eligibility and exclusion criteria, diagnoses, baseline liver disease, severity and demographic characteristics are unverified.	Adults with abdominal obesity or dyslipidemia and enrollment scope	Diet research with an explicit population boundary
4	Unverified	Full text not readStored summary read	N04 · Evidence conditionHow are sex, baseline liver fat and subgroups distinguished?Required	The current summary provides abdominal obesity or dyslipidemia and the total allocation count. It does not present findings and denominators by sex, baseline liver fat or disease-defined subgroups. R01	Required direct material has not been established within the current summary and unread external-material scope. Sex, baseline liver fat, subgroup denominators and effects, and interactions are unverified.	Baseline characteristics, liver-fat levels and population-specific denominators	Research with explicit population and subgroup plans
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionWhat did the bundled green-MED exposure include?Required	Green-MED combined walnuts, green tea, Mankai and greater restriction of red and processed meat. Original research exposures of 3-4 cups/day green tea and 100 g/day frozen Mankai are preserved only as study conditions. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. Ingredients, preparation and provision, whole-diet and energy targets, and actual adherence details are unverified.	The original package of walnuts, green tea, Mankai and meat restriction	Research specifying the bundled pattern and exposure scope
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionHow are common physical activity and walnut exposure distinguished across groups?Required	All three groups undertook a physical-activity program, and both MED groups received 28 g/day walnuts. Walnuts are not presented as unique to green-MED, and findings are not read as a diet-only effect without physical activity. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. Exercise, common support, walnut adherence and actual exposure differences by group are unverified.	Physical activity in all groups and 28 g/day walnuts in both MED groups	Research specifying common co-exposures and the dietary contrast of interest
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionWhat were the separate green-MED, conventional MED and HDG comparisons?Required	294 participants were allocated to healthy-diet guidance (HDG), MED and green-MED. Healthy-diet guidance in the original classification fields does not erase the conventional-MED comparison; each contrast is distinguished. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. Detailed HDG and MED targets, support, composition and exact contrast-specific effects and CIs are unverified.	Three-group comparisons and contrast-specific effects of interest	Research distinguishing comparator-specific effects of interest in advance
8	Unverified	Full text not readStored summary read	N08 · Evidence conditionWere food provision and actual dietary adherence established?Required	The original text describes receipt of foods and additional restrictions, but the summary does not provide detailed actual intake, adherence, cross-group contamination or exposure changes. R01	Required direct material has not been established within the current summary and unread external-material scope. Actual diets, support participation, departures, contamination and adherence denominators are unverified.	Provided exposure, intake and meat restriction, and departures	Research distinguishing exposure departures from allocation effects
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionHow are the 18-month endpoint and persistence after stopping distinguished?Required	The original trial lasted 18 months, and the selected outcome was 18-month MRS intrahepatic-fat change. Persistence, recurrence and longer-term outcomes after the intervention are not separately presented. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. Visit windows, outcomes after stopping exposure and persistence across time periods are unverified.	Intervention duration, outcome visits and additional follow-up	Research distinguishing the intervention endpoint from persistent effects
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionWhat were the units and methods for proton-MRS intrahepatic fat?Required	Intrahepatic fat was measured by proton MRS. Preserved figures describe proportional reduction in percent; absolute liver-fat fractions and calculation or measurement specifications are not separately provided. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. MRS equipment and location, eligibility criteria, unit definitions, reproducibility and original absolute measurements are unverified.	MRS liver-fat measurement, original units and calculation definitions	Intrahepatic-fat research with specified measurement and calculation methods
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionHow are the three group-specific proportional reductions preserved?Required	Original proportional reductions are green-MED -38.9%, MED -19.6% and HDG -12.2%. These remain group-change descriptions; no new between-group differences, percentage points or effect estimates are calculated. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. Proportional-change formulas, aggregation, group variability, denominators and CIs are unverified.	Original scope of green-MED -38.9%, MED -19.6% and HDG -12.2%	Plans distinguishing within-group changes from between-group effects of interest
12	Unverified	Full text not readStored summary read	N12 · Evidence conditionWere baseline and final absolute liver fat and absolute changes established?Required	The original summary presents only proportional reductions. Baseline and final absolute liver fat, absolute changes, percentage points and absolute between-group effects remain unverified. R01	Required direct material has not been established within the current summary and unread external-material scope. Absolute baseline and final values, changes, units and CIs are unverified.	Baseline and 18-month absolute MRS values, units and changes	Research specifying absolute and proportional effects of interest together
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionWhich contrast does weight-adjusted P=.035 describe?Required	The weight-loss-adjusted green-MED versus conventional MED comparison is recorded as P=.035. This P value is not treated as the same quantity as original group proportional reductions or effects and CIs for other contrasts. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. Adjusted models, covariates, effect units and estimates, CIs and denominators are unverified.	Green-MED versus MED adjusted for weight loss	Research distinguishing allocation contrasts from adjusted effects of interest
14	Unverified	Full text not readStored summary read	N14 · Evidence conditionAre other contrasts and unadjusted or adjusted effects kept separate?Required	The current summary specifies a significant P value only for weight-adjusted green-MED versus MED. Exact effects, CIs and P values for green-MED versus HDG, MED versus HDG and unadjusted comparisons are not separately established. R01	Required direct material has not been established within the current summary and unread external-material scope. Other contrasts, unadjusted results, multiplicity handling and CIs are unverified.	Green-MED versus HDG and MED versus HDG, and adjustment status	Research specifying group changes and planned comparisons
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionWhat numerical scope supports the historical wording of a small standardized effect?Required	The parent text describes a small standardized effect versus conventional MED. Exact standardized values, formulas and CIs are absent from the summary; no new d or effect grade is created. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. Standardized-effect units, definitions, values, CIs and importance thresholds are unverified.	Original small-effect wording and exact standardized values and CIs	Research prespecifying the effect of interest, precision and importance
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionWhat are the total 294 randomized participants and group denominators?Required	The original total of 294 randomized participants is preserved. Group allocation, MRS analysis and valid contrast-specific denominators are not separately presented in the summary. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. Denominators by group, time point, outcome and adjusted model are unverified.	Total allocation, group allocation and analysis, and time-specific denominators	Research distinguishing allocation from measurement and analysis denominators
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionAre 89.8% retention, 78% eligible MRS and the original 22% distinguished?Required	The evidence list separately records 89.8% retention at 18 months and 78% eligible follow-up MRS. The original 22% in the parent rationale is preserved as absence of eligible MRS. Retention and imaging eligibility are not presented as the same status. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. Exact denominators for each proportion, group counts and reasons for ineligibility or missingness are unverified.	Overall follow-up retention, imaging eligibility and original missingness wording	Plans distinguishing clinical follow-up from measurement eligibility
18	Unverified	Full text not readStored summary read	N18 · Evidence conditionAre subgroup and baseline liver-fat analysis denominators available?Required	The summary does not provide exact counts or analysis scope showing which baseline liver-fat levels or disease subgroups contributed valid observations to the current findings. R01	Required direct material has not been established within the current summary and unread external-material scope. Subgroup eligibility, group denominators, prespecified plans and interactions are unverified.	Overall MRS population and denominators by subgroup and baseline status	Research distinguishing overall and subgroup effects of interest
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionWere imaging missingness, eligibility exclusions and analysis populations established?Required	The original text records 78% eligible follow-up MRS and imaging missingness limitations. ITT, complete-case analysis, ineligibility, imputation and sensitivity details are not presented. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. Missingness and eligibility-exclusion reasons, group differences, imputation, sensitivity analyses and analysis populations are unverified.	Reasons for missing MRS, analysis populations, imputation and sensitivity analyses	Prespecified plans for imaging missingness and the effect of interest
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionWhat were three-group randomization, allocation concealment and baseline balance?Required	The original design is a three-arm 18-month randomized lifestyle trial. Actual allocation and concealment methods and baseline balance are not described in detail in the summary. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. Sequence generation, concealment, allocation responsibility and baseline balance are unverified.	Random sequence, concealment and three-group baseline information	Research with explicit three-group allocation, population and effects of interest
21	Unverified	Full text not readStored summary read	N21 · Evidence conditionWere MRS masking, standardization and assessment procedures established?Required	Use of proton MRS is preserved, but the summary does not provide assessor or reader masking, equipment and location standardization or reliability over time. R01	Required direct material has not been established within the current summary and unread external-material scope. Measurement, reading, eligibility adjudication, masking and error ranges are unverified.	Equipment, reader and time-point masking, and measurement consistency	Research with designated measurement and reading plans
22	Unverified	Full text not readStored summary read	N22 · Evidence conditionWhat were common exposures from baseline disease, medication and lifestyle?Required	The original text records physical activity in all groups and walnuts in both MED groups. Group-specific medication, comorbidity and other lifestyle-change details are not presented. R01	Required direct material has not been established within the current summary and unread external-material scope. Baseline and changed medications, diseases, concurrent exposures and support differences are unverified.	Concurrent treatment, baseline status and common support and activity	Research specifying common exposures and allocation contrasts
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionAre weight loss, adherence, component contributions and effects of interest distinguished?Required	Similar weight loss in both MED groups and the adjusted direction are preserved as originally described. These are not separated causal findings identifying a particular component or pathway beyond weight change. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. Weight and adherence models, mediation and component-specific effects of interest, and isolated-component comparisons are unverified.	Boundaries of weight adjustment, dietary adherence and single-component attribution	Research distinguishing the bundled pattern from component and mediation questions
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionAre registration, outcome hierarchy, reports and prior plans distinguished?Required	The evidence and citation lists record NCT03020186. MRS change in the original classification fields and historical registration-verification wording are preserved, but external registration, protocol and SAP material was not read in this work. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. Registration versions and timing, prespecified outcome hierarchy, analysis and multiplicity plans, and reporting changes are unverified.	NCT03020186 identification, actual plan reading and primary-outcome hierarchy	Research preserving designated outcomes, effects of interest and plan changes
25	Partly verified	Full text not readStored summary read	N25 · Evidence conditionHow are identities of reports, trials, groups and time points linked?Required	One existing evidence entry and one citation for Yaskolka Meir2021 DIRECT-PLUS are linked as one report. The three groups, 18 months, other time points and sibling questions are not added as new independent trials or participants. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. Relationships among other DIRECT-PLUS reports or populations and totals of unique trials and participants are unverified.	DIRECT-PLUS report identity and duplicate observations and participants	Records distinguishing reports from the same study family
26	Unverified	Full text not readStored summary read	N26 · Evidence conditionIs independent confirmation or direct replication available?Required	The original counterview states that independent confirmation trials are absent, while parent R1/I1 are historical axes. Other studies were not searched for or certified during this production. R01	Required direct material has not been established within the current summary and unread external-material scope. Current external search scope, independent report identities and duplication are unverified.	Independent studies and trial relationships for the same bundled-diet question	Separate confirmation research explicitly addressing the same question
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionCan effects by component, other dietary patterns or subgroup be established?Supplementary	The isolated-component question has grade ? and a note that individual component effects were not separated. Findings from the bundled diet are not attributed to Mankai, green tea or walnuts alone, or to other diets or subgroups. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. Direct effects and CIs for isolated components, other patterns and population-specific comparisons are unverified.	Direct comparisons of the bundled pattern with isolated components or other populations	Research distinguishing dietary-pattern contrasts from individual-component questions
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionWhich clinical outcomes does MRS liver fat address?Supplementary	The original text identifies intrahepatic fat as a surrogate and states that clinical liver-disease events are absent. MRS change does not establish direct effects on liver-disease treatment, progression, fibrosis, hospitalization or quality of life. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. Direct clinical events, function, quality of life, follow-up, denominators and CIs are unverified.	Surrogates, liver-disease events and patient-important outcomes	Plans distinguishing MRS from clinical events
29	Partly verified	Full text not readStored summary read	N29 · Evidence conditionWhat are the boundaries of the original long-term wording, persistence and extrapolation?Supplementary	The parent text describes strengths of the 18-month duration. Findings do not guarantee persistence after stopping, longer follow-up or efficacy in other populations or environments. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. Direct effects after stopping, during longer follow-up and in other populations are unverified.	18-month results, post-treatment follow-up and other long-term exposures	Research distinguishing persistence from extrapolation questions
30	Partly verified	Full text not readStored summary read	N30 · Evidence conditionWhat original information describes mixed funding and product interests?Required	Original funding wording describes German, Israeli and EU public support, California Walnut Commission support, the PI's disclosed Hinoman advisory role and funders' reported lack of involvement in design or analysis. Original disclosures have not been newly checked externally. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. Original disclosure details, product provision or access, and analysis roles are unverified.	Public and industry funding, advisory roles and funder involvement	Explicit reporting of funding and decision-making and analysis roles
31	Partly verified	Full text not readStored summary read	N31 · Evidence conditionWhat do stored-summary reading, external reading and URL access indicators mean?Required	The complete stored summary for 2984 was read for production and preserved as a copy. The PubMed URL, PMCID and registration identifier are original source links; external content reading, access and link testing were not performed. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. Current checks of external methods, results, registration and material content remain incomplete.	Reading scope of the complete stored summary, abstract, full text, registration and needed material	Production records distinguishing stored summaries from newly acquired material
32	Partly verified	Full text not readStored summary read	N32 · Evidence conditionWhat are the original Korean and English text, cut-off, empty values and historical axes?Required	Complete Korean and English text, original cut-off 2026-09-07, an empty corrections array and empty deliberation text are preserved. Parent C with 46 points, B/S/R1/I1/E~/B1, unrecorded precision, four false flags and empty override reasons are historical context, not current review or regrading results. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. External detailed translation, corrections and registration comparisons were not performed in this work.	Original language versions, dates, corrections, axes and parent verdict	Separation of original values from new material and changes
33	Unverified	Full text not readStored summary read	N33 · Evidence conditionHow were adverse events collected?Supplementary	The original safety explanation states that adverse-event ascertainment was not central to the efficacy report. Actual event definitions, collection methods, scope, severity and event tables are absent from the summary. R01	Required direct material has not been established within the current summary and unread external-material scope. Harm ascertainment and definitions, and complete event findings are unverified.	Event definitions, active or passive collection, severity and denominators	Research with explicit harm ascertainment alongside efficacy
34	Partly verified	Full text not readStored summary read	N34 · Evidence conditionDo nut-allergy and caffeine-sensitivity statements describe actual events?Supplementary	The original text separately mentions nut allergy, caffeine sensitivity and disease-specific dietary suitability. This is not a quantitative or causal finding that a particular event occurred in this trial. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. Enrollment, events, condition-specific denominators and severity in the relevant populations are unverified.	Original cautionary context distinguished from collected harms	Safety questions specifying the relevant vulnerable scope
35	Unverified	Full text not readStored summary read	N35 · Evidence conditionWere group-specific harm events, denominators and comparisons established?Supplementary	The summary lacks group-specific harm events and collection denominators. The total 294 participants, retention and eligible MRS are not automatically used as harm-analysis denominators. R01	Required direct material has not been established within the current summary and unread external-material scope. Harm denominators, effects and CIs by group, event and period are unverified.	Valid harm ascertainment in three groups, event and exposure denominators and effects	Research distinguishing efficacy measurements from harm-collection populations
36	Unverified	Full text not readStored summary read	N36 · Evidence conditionWhat were harm timing, exposure duration and delayed follow-up?Supplementary	An 18-month lifestyle trial is described, but the summary lacks harm onset times, repeated exposure and post-treatment or delayed harm observation. R01	Required direct material has not been established within the current summary and unread external-material scope. Harm timing and observation, exposure changes and post-treatment findings are unverified.	Time-specific symptoms and harm observation after discontinuation or study end	Research with symptom, timing and delayed-observation plans
37	Unverified	Full text not readStored summary read	N37 · Evidence conditionHow is harm attribution handled for the bundled diet, common exposures and medical history?Supplementary	The diet was bundled, with common physical-activity and walnut exposures. Actual causal or relatedness material attributing harms to a particular food or the whole diet was not provided. R01	Required direct material has not been established within the current summary and unread external-material scope. Event-specific exposure, history, concurrent medication, relatedness assessment and alternative causes are unverified.	Food, activity, concurrent medication, disease and event causality	Harm research distinguishing bundled interventions from alternative causes
38	Unverified	Full text not readStored summary read	N38 · Evidence conditionAre retention, imaging missingness, harms and discontinuation reasons distinguished?Supplementary	Original retention of 89.8% and eligible MRS of 78% are recorded. Harm, motivation and examination-related reasons for each missing or ineligible observation, and harm collection in participants with missing data, remain unverified. R01	Required direct material has not been established within the current summary and unread external-material scope. Group-specific missingness and discontinuation reasons, relationships to harms and collection of missing harm data are unverified.	Harm-related discontinuation, missingness and ineligibility reasons, and collection	A plan separating missingness from harm-related discontinuation
39	Unverified	Full text not readStored summary read	N39 · Evidence conditionWere independent harm studies or separate event material acquired?Supplementary	The current preserved list contains this one efficacy report. Independent original harm material was not searched for or acquired here, and results from the same trial are not counted as a separate harm trial. R01	Required direct material has not been established within the current summary and unread external-material scope. Independent harm-report identity, populations, exposures and duplication are unverified.	Independent safety material matching the diet, population and exposure	Independent harm research with explicit population and dietary exposure
40	Unverified	Full text not readStored summary read	N40 · Evidence conditionWhat are the safety boundaries for vulnerable populations, baseline liver disease and long-term exposure?Supplementary	Original wording separately mentions individual disease, dietary suitability, allergy and sensitivity. Safety findings in particular liver-disease subtypes, vulnerable populations or longer exposures are not presented. R01	Required direct material has not been established within the current summary and unread external-material scope. Population-specific history, medication, exposure, direct events and follow-up are unverified.	Subtypes, disease, medication, allergy, sensitivity and long-term observation	Research specifying population and long-term safety questions
41	Partly verified	Full text not readStored summary read	N41 · Evidence conditionAre liver-fat reduction, unknown safety and causal judgments distinguished?Supplementary	Parent safety is unknown. Liver-fat reduction does not establish comparative safety, clinical liver-disease events or component-specific causal safety. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. Direct comparative events, causality, precision and long-term harm findings are unverified.	Efficacy surrogates, original safety and comparative harms	Research separating safety from surrogate effects of interest
42	Partly verified	Full text not readStored summary read	N42 · Evidence conditionHow are later material, condition versions and original values updated?Supplementary	The complete stored summary is preserved and conditions are saved and frozen before separate application. Additional material is linked to events distinguishing absolute and proportional values, adjustment, denominators, populations, comparisons, original values and actual reading. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. Later original material and actual reading or change events are not yet available.	Identity, population, comparator, units, denominators, timing, reading and change events	Research addressing direct gaps in the selected bundled-diet question
43	Partly verified	Full text not readStored summary read	N43 · Evidence conditionHow are historical candidate records distinguished from current content-review status?Supplementary	Original candidate review-pending and eligibility indicators are preserved. No new model, content or question-boundary review was performed; incomplete review, false completion flags, zero new units and unrecorded final independent counts are retained. R01	Some original summary information is linked for production; this does not establish completed clinical verification or content review. Later review decisions and final independence counts remain unresolved.	Historical candidate records, production status and new-unit counts	Records distinguishing the original question, production and review decisions

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43 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-09-07
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: Adults with abdominal obesity or dyslipidemia; the original 294 randomized participants, retention and eligible-MRS proportions remain within their reported scope.
Ingredient, formulation and route: A green Mediterranean diet combining walnuts, green tea, Mankai and restriction of red and processed meat.
Dose: Original research exposures: both MED groups received 28 g/day walnuts; green-MED added 3-4 cups/day green tea, 100 g/day frozen Mankai and greater red and processed meat restriction. These are preserved study conditions, not diet or intake instructions.
Comparator: Conventional MED and healthy-diet guidance, HDG; physical activity was common to all groups and walnuts to both MED groups.
Measured outcome: 18-month intrahepatic-fat change by proton MRS; distinguish original proportional reductions from the weight-adjusted green-MED versus MED P value.
Duration: 18 months
Questions outside this scope: Attributing effects to Mankai, green tea or walnuts alone, or creating new isolated-component question splits; Converting proportional reductions into absolute fat, percentage points, adjusted between-group effects or CIs; Adding the same trial, participants, groups or time points as independent trials or participants; Extending MRS changes into clinical liver-disease events or successful treatment replacement; Diet, product or intake, weight or liver-disease management, or treatment-replacement instructions

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · Yaskolka Meir A, Rinott E, Tsaban G, et al. Effect of green-Mediterranean diet on intrahepatic fat: the DIRECT PLUS randomised controlled trial. Gut. 2021;70(11):2085-2095. PMID: 33461965. PMCID: PMC8515100. DOI: 10.1136/gutjnl-2020-323106. NCT03020186.

PubMed

Material type: Stored report of three-group 18-month MRS results from the DIRECT-PLUS bundled lifestyle trial
Materials actually read: Summary read; external materials unread, access not attempted
Findings recorded in the stored summary: Green-MED -38.9%, MED -19.6%, HDG -12.2%; weight-adjusted green-MED versus MED P=.035
Record level: 18-month proportional MRS changes for a bundled diet and the weight-adjusted green-MED versus MED P value. Absolute or adjusted effect estimates, CIs and group or subgroup denominators are unverified. These are not isolated-component or clinical liver-disease event results.
Study overlap and independent replication: Yaskolka Meir2021 DIRECT-PLUS links the same report and trial across three groups, 18 months, the parent verdict, bundled-diet question and isolated-component question. Other groups, time points and components are not newly added to independent-trial or participant totals.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Local preserved summary	Summary read	Summary read	Acquisition and reading of the complete parent summary only, not original external papers or registration material.
Abstract	External materials unread/needed	Unread; access not attempted	Not read	Only the original citation link is provided. External access, content checking and link testing were not attempted.
Full paper	External materials unread/needed	Unread; access not attempted	Not read	The original PMCID reference is retained; full-text content has not been newly obtained or read.
Registration material	External materials unread/needed	Unread; access not attempted	Not read	Original NCT03020186 identifier preserved. Registration versions and content are unread; access was not attempted.
Protocol	External materials unread/needed	Unread; access not attempted	Not read	Original plans for intervention and comparator, MRS eligibility, outcome hierarchy and harms are needed. Existence and public availability are unverified.
Statistical analysis plan	External materials unread/needed	Unread; access not attempted	Not read	Original plans concerning adjustment, effects of interest, imaging missingness, contrasts and subgroups are needed.
Result tables and MRS, denominator and harm records	External materials unread/needed	Unread; access not attempted	Not read	Original absolute and proportional results, groups and time points, baseline and subgroup information, retention, imaging eligibility and harm material are needed. No new calculations are produced.
Funding/conflict-of-interest disclosures	External materials unread/needed	Unread; access not attempted	Not read	Original disclosures of public and industry support, advisory roles and funder involvement are currently unread.

Report counts versus independent study counts

Yaskolka Meir2021 DIRECT-PLUS links the same report and trial across three groups, 18 months, the parent verdict, bundled-diet question and isolated-component question. Other groups, time points and components are not newly added to independent-trial or participant totals.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · How are the selected question and the isolated-component question distinguished?

Required materials and conditions: Selected question and verdict record, with parent and isolated-component boundaries
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Selected question and verdict record, with parent and isolated-component boundaries.
Requirement and applicability: Required
Application exceptions: The original isolated-component question has grade ? and a note that individual effects were not separated. These are not filled with the bundled-diet grade C.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are the selected question and the isolated-component question distinguished?
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M03 §3.2.4; internally defined extension boundaries

N02 · How are the original subclaim grade, note and absent values preserved?

Required materials and conditions: Subclaim C and note, absent score, status and axes, and parent history
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Subclaim C and note, absent score, status and axes, and parent history.
Requirement and applicability: Required
Application exceptions: Parent 46 points are not transferred into the subclaim score, and C is not inherited as a current passed content review or efficacy certification.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are the original subclaim grade, note and absent values preserved?
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

N03 · What was the actual study population?

Required materials and conditions: Adults with abdominal obesity or dyslipidemia and enrollment scope
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Adults with abdominal obesity or dyslipidemia and enrollment scope.
Requirement and applicability: Required
Application exceptions: MRS liver-fat changes are not extended into treatment effects for liver disease generally.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What was the actual study population?
Referenced methods: M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application

N04 · How are sex, baseline liver fat and subgroups distinguished?

Required materials and conditions: Baseline characteristics, liver-fat levels and population-specific denominators
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Baseline characteristics, liver-fat levels and population-specific denominators.
Requirement and applicability: Required
Application exceptions: Population counts or proportions possibly known from other reports are not newly added, and overall findings are not copied into subgroups.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are sex, baseline liver fat and subgroups distinguished?
Referenced methods: M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application

N05 · What did the bundled green-MED exposure include?

Required materials and conditions: The original package of walnuts, green tea, Mankai and meat restriction
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: The original package of walnuts, green tea, Mankai and meat restriction.
Requirement and applicability: Required
Application exceptions: No new implementation guidance for menus, intake, products or dose conversions is produced.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What did the bundled green-MED exposure include?
Referenced methods: M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed

N06 · How are common physical activity and walnut exposure distinguished across groups?

Required materials and conditions: Physical activity in all groups and 28 g/day walnuts in both MED groups
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Physical activity in all groups and 28 g/day walnuts in both MED groups.
Requirement and applicability: Required
Application exceptions: Common-exposure quantities are original research information, not exercise or intake instructions.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are common physical activity and walnut exposure distinguished across groups?
Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

N07 · What were the separate green-MED, conventional MED and HDG comparisons?

Required materials and conditions: Three-group comparisons and contrast-specific effects of interest
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Three-group comparisons and contrast-specific effects of interest.
Requirement and applicability: Required
Application exceptions: The adjusted green-MED versus MED P value is not copied into green-MED versus HDG or MED versus HDG.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What were the separate green-MED, conventional MED and HDG comparisons?
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are Chamgap design; M08 §8.2.2, M15 §15.3.1; Chamgap adaptation

N08 · Were food provision and actual dietary adherence established?

Required materials and conditions: Provided exposure, intake and meat restriction, and departures
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Provided exposure, intake and meat restriction, and departures.
Requirement and applicability: Required
Application exceptions: Provision targets are not treated as every participant's actual intake or dose.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Were food provision and actual dietary adherence established?
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed

N09 · How are the 18-month endpoint and persistence after stopping distinguished?

Required materials and conditions: Intervention duration, outcome visits and additional follow-up
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Intervention duration, outcome visits and additional follow-up.
Requirement and applicability: Required
Application exceptions: 18 months is not recast as guaranteed persistence for everyone or a liver-disease management schedule.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are the 18-month endpoint and persistence after stopping distinguished?
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed

N10 · What were the units and methods for proton-MRS intrahepatic fat?

Required materials and conditions: MRS liver-fat measurement, original units and calculation definitions
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: MRS liver-fat measurement, original units and calculation definitions.
Requirement and applicability: Required
Application exceptions: Proportional reductions are not recast as absolute fat content, percentage-point change or disappearance of liver fat.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What were the units and methods for proton-MRS intrahepatic fat?
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; Internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed

N11 · How are the three group-specific proportional reductions preserved?

Required materials and conditions: Original scope of green-MED -38.9%, MED -19.6% and HDG -12.2%
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Original scope of green-MED -38.9%, MED -19.6% and HDG -12.2%.
Requirement and applicability: Required
Application exceptions: -38.9% is not attributed to Mankai alone or presented as a guaranteed personal reduction.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are the three group-specific proportional reductions preserved?
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application

N12 · Were baseline and final absolute liver fat and absolute changes established?

Required materials and conditions: Baseline and 18-month absolute MRS values, units and changes
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Baseline and 18-month absolute MRS values, units and changes.
Requirement and applicability: Required
Application exceptions: Absolute liver-fat quantities or percentage points are not reconstructed from original proportional values.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Were baseline and final absolute liver fat and absolute changes established?
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application

N13 · Which contrast does weight-adjusted P=.035 describe?

Required materials and conditions: Green-MED versus MED adjusted for weight loss
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Green-MED versus MED adjusted for weight loss.
Requirement and applicability: Required
Application exceptions: Weight adjustment does not isolate individual components or conclusively establish mechanisms beyond weight change.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Which contrast does weight-adjusted P=.035 describe?
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application

N14 · Are other contrasts and unadjusted or adjusted effects kept separate?

Required materials and conditions: Green-MED versus HDG and MED versus HDG, and adjustment status
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Green-MED versus HDG and MED versus HDG, and adjustment status.
Requirement and applicability: Required
Application exceptions: The ordering of the three proportional reductions does not establish significance for every between-group comparison.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are other contrasts and unadjusted or adjusted effects kept separate?
Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application

N15 · What numerical scope supports the historical wording of a small standardized effect?

Required materials and conditions: Original small-effect wording and exact standardized values and CIs
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Original small-effect wording and exact standardized values and CIs.
Requirement and applicability: Required
Application exceptions: Original E~, unrecorded precision and small-effect wording are historical values, not current recalculation or regrading results.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What numerical scope supports the historical wording of a small standardized effect?
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is internally designed; M15 §15.3.1–15.3.3; internal application

N16 · What are the total 294 randomized participants and group denominators?

Required materials and conditions: Total allocation, group allocation and analysis, and time-specific denominators
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Total allocation, group allocation and analysis, and time-specific denominators.
Requirement and applicability: Required
Application exceptions: The total is not divided by the number of groups, and participant counts are not newly added or estimated.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What are the total 294 randomized participants and group denominators?
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

N17 · Are 89.8% retention, 78% eligible MRS and the original 22% distinguished?

Required materials and conditions: Overall follow-up retention, imaging eligibility and original missingness wording
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Overall follow-up retention, imaging eligibility and original missingness wording.
Requirement and applicability: Required
Application exceptions: Original proportions are not converted into new participant counts or attrition rates, and 22% is not calculated from 89.8%.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are 89.8% retention, 78% eligible MRS and the original 22% distinguished?
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design; M08 §8.2.2, M15 §15.3.1; own application; M19 §19.1.2–19.2.4, M04 §4.6.3; own application

N18 · Are subgroup and baseline liver-fat analysis denominators available?

Required materials and conditions: Overall MRS population and denominators by subgroup and baseline status
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Overall MRS population and denominators by subgroup and baseline status.
Requirement and applicability: Required
Application exceptions: The overall 294 participants or 78% are not copied as analysis counts for every subgroup.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are subgroup and baseline liver-fat analysis denominators available?
Referenced methods: M03 §3.2.1; detailed population conditions are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application

N19 · Were imaging missingness, eligibility exclusions and analysis populations established?

Required materials and conditions: Reasons for missing MRS, analysis populations, imputation and sensitivity analyses
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Reasons for missing MRS, analysis populations, imputation and sensitivity analyses.
Requirement and applicability: Required
Application exceptions: All absent imaging is not recast as attrition or harm events, or treated as zero effect.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Were imaging missingness, eligibility exclusions and analysis populations established?
Referenced methods: M08 §8.2.2, M15 §15.3.1; Internal application; M08 Table 8.2.a, M04 §4.6.3; Internal application

N20 · What were three-group randomization, allocation concealment and baseline balance?

Required materials and conditions: Random sequence, concealment and three-group baseline information
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Random sequence, concealment and three-group baseline information.
Requirement and applicability: Required
Application exceptions: The RCT label and historical parent B1/I1 axes do not certify adequate allocation or absence of bias in a current review.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What were three-group randomization, allocation concealment and baseline balance?
Referenced methods: M08 §8.1–8.2.3; own application

N21 · Were MRS masking, standardization and assessment procedures established?

Required materials and conditions: Equipment, reader and time-point masking, and measurement consistency
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Equipment, reader and time-point masking, and measurement consistency.
Requirement and applicability: Required
Application exceptions: Objective imaging alone does not establish absence of measurement influences or bias.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Were MRS masking, standardization and assessment procedures established?
Referenced methods: M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M08 §§8.1–8.2.3; Chamgap adaptation

N22 · What were common exposures from baseline disease, medication and lifestyle?

Required materials and conditions: Concurrent treatment, baseline status and common support and activity
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Concurrent treatment, baseline status and common support and activity.
Requirement and applicability: Required
Application exceptions: Unknown medications or diseases, or treatment replacement, are not added as original study components.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What were common exposures from baseline disease, medication and lifestyle?
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed

N23 · Are weight loss, adherence, component contributions and effects of interest distinguished?

Required materials and conditions: Boundaries of weight adjustment, dietary adherence and single-component attribution
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Boundaries of weight adjustment, dietary adherence and single-component attribution.
Requirement and applicability: Required
Application exceptions: The adjusted P value and similar weight loss do not certify Mankai or green-tea efficacy alone.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are weight loss, adherence, component contributions and effects of interest distinguished?
Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.4; internally defined extension boundaries

N24 · Are registration, outcome hierarchy, reports and prior plans distinguished?

Required materials and conditions: NCT03020186 identification, actual plan reading and primary-outcome hierarchy
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: NCT03020186 identification, actual plan reading and primary-outcome hierarchy.
Requirement and applicability: Required
Application exceptions: Identifiers, original outcome labels and false axis flags alone do not certify prespecified primary status or reading of registration content.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are registration, outcome hierarchy, reports and prior plans distinguished?
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.5–4.6 material collection and selection principles; separation of access and reading and the hyperlink contract are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed

N25 · How are identities of reports, trials, groups and time points linked?

Required materials and conditions: DIRECT-PLUS report identity and duplicate observations and participants
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: DIRECT-PLUS report identity and duplicate observations and participants.
Requirement and applicability: Required
Application exceptions: The one currently linked report is not a total count of independent trials or new independence certification.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are identities of reports, trials, groups and time points linked?
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

N26 · Is independent confirmation or direct replication available?

Required materials and conditions: Independent studies and trial relationships for the same bundled-diet question
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Independent studies and trial relationships for the same bundled-diet question.
Requirement and applicability: Required
Application exceptions: Original absence wording is not promoted into a current worldwide absence check, and reports from the same trial are not counted as independent replication.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Is independent confirmation or direct replication available?
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

N27 · Can effects by component, other dietary patterns or subgroup be established?

Required materials and conditions: Direct comparisons of the bundled pattern with isolated components or other populations
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Direct comparisons of the bundled pattern with isolated components or other populations.
Requirement and applicability: Supplementary
Application exceptions: The advertising example of 39% is not adopted as a new trial figure or component effect.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Can effects by component, other dietary patterns or subgroup be established?
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed

N28 · Which clinical outcomes does MRS liver fat address?

Required materials and conditions: Surrogates, liver-disease events and patient-important outcomes
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Surrogates, liver-disease events and patient-important outcomes.
Requirement and applicability: Supplementary
Application exceptions: No new liver-disease management or treatment-replacement instructions or disease-event prevention efficacy are created.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Which clinical outcomes does MRS liver fat address?
Referenced methods: M03 §3.2.4; internally defined extension boundaries

N29 · What are the boundaries of the original long-term wording, persistence and extrapolation?

Required materials and conditions: 18-month results, post-treatment follow-up and other long-term exposures
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: 18-month results, post-treatment follow-up and other long-term exposures.
Requirement and applicability: Supplementary
Application exceptions: 18 months is not recast as a lifelong management effect or a recommended diet for every liver-disease population.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What are the boundaries of the original long-term wording, persistence and extrapolation?
Referenced methods: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap’s own design; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

N30 · What original information describes mixed funding and product interests?

Required materials and conditions: Public and industry funding, advisory roles and funder involvement
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Public and industry funding, advisory roles and funder involvement.
Requirement and applicability: Required
Application exceptions: Reported non-involvement is not recast as current certification of no interests, and support alone does not lead to a verdict of ineffective treatment.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What original information describes mixed funding and product interests?
Referenced methods: Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item; M08 §8.1–8.2.3; internal application

N31 · What do stored-summary reading, external reading and URL access indicators mean?

Required materials and conditions: Reading scope of the complete stored summary, abstract, full text, registration and needed material
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Reading scope of the complete stored summary, abstract, full text, registration and needed material.
Requirement and applicability: Required
Application exceptions: The presence of a link, PMCID or NCT identifier is not assigned acquisition, reading or successful-access status.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What do stored-summary reading, external reading and URL access indicators mean?
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

N32 · What are the original Korean and English text, cut-off, empty values and historical axes?

Required materials and conditions: Original language versions, dates, corrections, axes and parent verdict
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Original language versions, dates, corrections, axes and parent verdict.
Requirement and applicability: Required
Application exceptions: Historical Codex full-text, registry and scoring verification wording is not inherited as a current passed external reading or content review.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What are the original Korean and English text, cut-off, empty values and historical axes?
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item

N33 · How were adverse events collected?

Required materials and conditions: Event definitions, active or passive collection, severity and denominators
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Event definitions, active or passive collection, severity and denominators.
Requirement and applicability: Supplementary
Application exceptions: Not being central is not recast as zero adverse events or confirmed absence of actual collection.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How were adverse events collected?
Referenced methods: M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP

N34 · Do nut-allergy and caffeine-sensitivity statements describe actual events?

Required materials and conditions: Original cautionary context distinguished from collected harms
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Original cautionary context distinguished from collected harms.
Requirement and applicability: Supplementary
Application exceptions: No new intake, product avoidance or recommendation, disease-specific diet or treatment instructions are written.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Do nut-allergy and caffeine-sensitivity statements describe actual events?
Referenced methods: M19 §19.1.2–19.2.4; detailed distinctions are internally designed; Internally defined Chamgap interpretation boundaries, referring to M19 principles without applying an official causality tool; M19 §19.1.2–19.2.4; internal application

N35 · Were group-specific harm events, denominators and comparisons established?

Required materials and conditions: Valid harm ascertainment in three groups, event and exposure denominators and effects
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Valid harm ascertainment in three groups, event and exposure denominators and effects.
Requirement and applicability: Supplementary
Application exceptions: No new zero-event counts, zero incidence, risk differences or CIs are calculated.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Were group-specific harm events, denominators and comparisons established?
Referenced methods: M19 §19.2.2–19.2.4, M03 §3.2.3; internal application; M19 §19.1.2–19.2.4; internal application

N36 · What were harm timing, exposure duration and delayed follow-up?

Required materials and conditions: Time-specific symptoms and harm observation after discontinuation or study end
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Time-specific symptoms and harm observation after discontinuation or study end.
Requirement and applicability: Supplementary
Application exceptions: 18-month efficacy follow-up is not recast as completed verification of long-term safety.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What were harm timing, exposure duration and delayed follow-up?
Referenced methods: M19 §19.2 design-specific harm questions; temporal-relationship details are internally designed; M19 §19.1.2–19.2.4; internal application

N37 · How is harm attribution handled for the bundled diet, common exposures and medical history?

Required materials and conditions: Food, activity, concurrent medication, disease and event causality
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Food, activity, concurrent medication, disease and event causality.
Requirement and applicability: Supplementary
Application exceptions: General food-risk warnings are not recast as confirmed causes or events in this trial.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How is harm attribution handled for the bundled diet, common exposures and medical history?
Referenced methods: M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation

N38 · Are retention, imaging missingness, harms and discontinuation reasons distinguished?

Required materials and conditions: Harm-related discontinuation, missingness and ineligibility reasons, and collection
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Harm-related discontinuation, missingness and ineligibility reasons, and collection.
Requirement and applicability: Supplementary
Application exceptions: The original 22% is not converted into an adverse-effect rate or a count of participants lost to follow-up.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are retention, imaging missingness, harms and discontinuation reasons distinguished?
Referenced methods: M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application

N39 · Were independent harm studies or separate event material acquired?

Required materials and conditions: Independent safety material matching the diet, population and exposure
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Independent safety material matching the diet, population and exposure.
Requirement and applicability: Supplementary
Application exceptions: Absence of a separate current slot does not establish worldwide absence of harm reports.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Were independent harm studies or separate event material acquired?
Referenced methods: M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations

N40 · What are the safety boundaries for vulnerable populations, baseline liver disease and long-term exposure?

Required materials and conditions: Subtypes, disease, medication, allergy, sensitivity and long-term observation
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Subtypes, disease, medication, allergy, sensitivity and long-term observation.
Requirement and applicability: Supplementary
Application exceptions: No new dietary management, product or intake, weight-management or liver-disease treatment-replacement guidance is produced.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What are the safety boundaries for vulnerable populations, baseline liver disease and long-term exposure?
Referenced methods: M19 §19.1.2–19.2.4; Internal application; Design considerations in M19 §19.2.2–19.2.4; Detailed confounding records are internally designed

N41 · Are liver-fat reduction, unknown safety and causal judgments distinguished?

Required materials and conditions: Efficacy surrogates, original safety and comparative harms
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Efficacy surrogates, original safety and comparative harms.
Requirement and applicability: Supplementary
Application exceptions: Unknown is not recast as zero events, confirmed harm or guaranteed safety.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are liver-fat reduction, unknown safety and causal judgments distinguished?
Referenced methods: Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool; M03 §3.2.4; Internally defined extrapolation boundaries

N42 · How are later material, condition versions and original values updated?

Required materials and conditions: Identity, population, comparator, units, denominators, timing, reading and change events
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Identity, population, comparator, units, denominators, timing, reading and change events.
Requirement and applicability: Supplementary
Application exceptions: Production completion does not establish completed clinical review or publication.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are later material, condition versions and original values updated?
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application

N43 · How are historical candidate records distinguished from current content-review status?

Required materials and conditions: Historical candidate records, production status and new-unit counts
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Historical candidate records, production status and new-unit counts.
Requirement and applicability: Supplementary
Application exceptions: Historical full-text, registration and scoring verification wording is not invented as a current passed clinical review or external reading.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are historical candidate records distinguished from current content-review status?
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Preserved records of methodological application were referenced. Methodological source content was not newly reviewed in this work.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Preserved records of methodological application were referenced. Methodological source content was not newly reviewed in this work.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Preserved records of methodological application were referenced. Methodological source content was not newly reviewed in this work.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Preserved records of methodological application were referenced. Methodological source content was not newly reviewed in this work.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Preserved records of methodological application were referenced. Methodological source content was not newly reviewed in this work.

What the statuses mean

Met: The original content has been reviewed as meeting the conditions. This status is not used in this preparation.
Partly verified: Some information in the stored summary was linked during preparation; clinical verification or review is not complete.
Unverified: Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.
Review incomplete: Review of existing content or actual review incomplete.
Not reported: Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.
Inaccessible: Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.
Insufficient evidence for the conditions: Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.
Not applicable: Used when the reason it does not apply to the original question is stated.
Conflicting data: Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment.

Change history

2026-10-15 · Public page/material version 1.0

Public pages and materials were prepared from the existing 43 items. No new clinical search, verification-status change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-09-07) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · How are the selected question and the isolated-component question distinguished?

Current findings: The selected existing question is 18-month intrahepatic-fat reduction from the bundled green-MED pattern, linked to its subclaim record. Liver-fat reduction from Mankai or green tea alone is preserved as context; no new split or verdict is created.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. Clinical independence and isolated-component effects have not been newly certified.
Reason for missing information: Clinical independence and isolated-component effects have not been newly certified.
Required materials and conditions: Selected question and verdict record, with parent and isolated-component boundaries
Materials to obtain first: Records of changes to the original question, intervention, population, comparator, duration and scope
Further research: Research questions distinguishing bundled diets from individual components
Remaining uncertainty: Clinical independence and isolated-component effects have not been newly certified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Selected question and verdict record, with parent and isolated-component boundaries.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are the selected question and the isolated-component question distinguished?
Application exceptions: The original isolated-component question has grade ? and a note that individual effects were not separated. These are not filled with the bundled-diet grade C.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M03 §3.2.4; internally defined extension boundaries

Related sources R01

N02 · How are the original subclaim grade, note and absent values preserved?

Current findings: Subclaim grade C and the note, weight-adjusted P=.035 versus conventional MED, are preserved. Subclaim score, status and axes are absent; parent C with 46 points and axes provide separate historical context.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. The selected subclaim score, status and axes are absent from the original.
Reason for missing information: The selected subclaim score, status and axes are absent from the original.
Required materials and conditions: Subclaim C and note, absent score, status and axes, and parent history
Materials to obtain first: Original subclaim and an explicit change event
Further research: Records distinguishing additional evidence from preservation of the original grade
Remaining uncertainty: The selected subclaim score, status and axes are absent from the original.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Subclaim C and note, absent score, status and axes, and parent history.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are the original subclaim grade, note and absent values preserved?
Application exceptions: Parent 46 points are not transferred into the subclaim score, and C is not inherited as a current passed content review or efficacy certification.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Related sources R01

N03 · What was the actual study population?

Current findings: The original research explanation records 294 adults with abdominal obesity or dyslipidemia. This is not recast as requiring both conditions together or as findings in every patient with liver disease.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. Exact eligibility and exclusion criteria, diagnoses, baseline liver disease, severity and demographic characteristics are unverified.
Reason for missing information: Exact eligibility and exclusion criteria, diagnoses, baseline liver disease, severity and demographic characteristics are unverified.
Required materials and conditions: Adults with abdominal obesity or dyslipidemia and enrollment scope
Materials to obtain first: Eligibility, baseline characteristics and liver-disease diagnostic material
Further research: Diet research with an explicit population boundary
Remaining uncertainty: Exact eligibility and exclusion criteria, diagnoses, baseline liver disease, severity and demographic characteristics are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Adults with abdominal obesity or dyslipidemia and enrollment scope.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What was the actual study population?
Application exceptions: MRS liver-fat changes are not extended into treatment effects for liver disease generally.
Referenced methods: M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application

Related sources R01

N04 · How are sex, baseline liver fat and subgroups distinguished?

Current findings: The current summary provides abdominal obesity or dyslipidemia and the total allocation count. It does not present findings and denominators by sex, baseline liver fat or disease-defined subgroups.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been established within the current summary and unread external-material scope. Sex, baseline liver fat, subgroup denominators and effects, and interactions are unverified.
Reason for missing information: Sex, baseline liver fat, subgroup denominators and effects, and interactions are unverified.
Required materials and conditions: Baseline characteristics, liver-fat levels and population-specific denominators
Materials to obtain first: Baseline and subgroup tables and prespecified analyses
Further research: Research with explicit population and subgroup plans
Remaining uncertainty: Sex, baseline liver fat, subgroup denominators and effects, and interactions are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Baseline characteristics, liver-fat levels and population-specific denominators.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are sex, baseline liver fat and subgroups distinguished?
Application exceptions: Population counts or proportions possibly known from other reports are not newly added, and overall findings are not copied into subgroups.
Referenced methods: M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application

Related sources R01

N05 · What did the bundled green-MED exposure include?

Current findings: Green-MED combined walnuts, green tea, Mankai and greater restriction of red and processed meat. Original research exposures of 3-4 cups/day green tea and 100 g/day frozen Mankai are preserved only as study conditions.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. Ingredients, preparation and provision, whole-diet and energy targets, and actual adherence details are unverified.
Reason for missing information: Ingredients, preparation and provision, whole-diet and energy targets, and actual adherence details are unverified.
Required materials and conditions: The original package of walnuts, green tea, Mankai and meat restriction
Materials to obtain first: Intervention specifications, provision and adherence records, and the original protocol
Further research: Research specifying the bundled pattern and exposure scope
Remaining uncertainty: Ingredients, preparation and provision, whole-diet and energy targets, and actual adherence details are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: The original package of walnuts, green tea, Mankai and meat restriction.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What did the bundled green-MED exposure include?
Application exceptions: No new implementation guidance for menus, intake, products or dose conversions is produced.
Referenced methods: M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed

Related sources R01

N06 · How are common physical activity and walnut exposure distinguished across groups?

Current findings: All three groups undertook a physical-activity program, and both MED groups received 28 g/day walnuts. Walnuts are not presented as unique to green-MED, and findings are not read as a diet-only effect without physical activity.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. Exercise, common support, walnut adherence and actual exposure differences by group are unverified.
Reason for missing information: Exercise, common support, walnut adherence and actual exposure differences by group are unverified.
Required materials and conditions: Physical activity in all groups and 28 g/day walnuts in both MED groups
Materials to obtain first: Common-program, food-provision and group adherence material
Further research: Research specifying common co-exposures and the dietary contrast of interest
Remaining uncertainty: Exercise, common support, walnut adherence and actual exposure differences by group are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Physical activity in all groups and 28 g/day walnuts in both MED groups.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are common physical activity and walnut exposure distinguished across groups?
Application exceptions: Common-exposure quantities are original research information, not exercise or intake instructions.
Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

Related sources R01

N07 · What were the separate green-MED, conventional MED and HDG comparisons?

Current findings: 294 participants were allocated to healthy-diet guidance (HDG), MED and green-MED. Healthy-diet guidance in the original classification fields does not erase the conventional-MED comparison; each contrast is distinguished.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. Detailed HDG and MED targets, support, composition and exact contrast-specific effects and CIs are unverified.
Reason for missing information: Detailed HDG and MED targets, support, composition and exact contrast-specific effects and CIs are unverified.
Required materials and conditions: Three-group comparisons and contrast-specific effects of interest
Materials to obtain first: Intervention and support specifications for each group and contrast-specific analysis tables
Further research: Research distinguishing comparator-specific effects of interest in advance
Remaining uncertainty: Detailed HDG and MED targets, support, composition and exact contrast-specific effects and CIs are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Three-group comparisons and contrast-specific effects of interest.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What were the separate green-MED, conventional MED and HDG comparisons?
Application exceptions: The adjusted green-MED versus MED P value is not copied into green-MED versus HDG or MED versus HDG.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are Chamgap design; M08 §8.2.2, M15 §15.3.1; Chamgap adaptation

Related sources R01

N08 · Were food provision and actual dietary adherence established?

Current findings: The original text describes receipt of foods and additional restrictions, but the summary does not provide detailed actual intake, adherence, cross-group contamination or exposure changes.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been established within the current summary and unread external-material scope. Actual diets, support participation, departures, contamination and adherence denominators are unverified.
Reason for missing information: Actual diets, support participation, departures, contamination and adherence denominators are unverified.
Required materials and conditions: Provided exposure, intake and meat restriction, and departures
Materials to obtain first: Diet and adherence records, provision history and the protocol
Further research: Research distinguishing exposure departures from allocation effects
Remaining uncertainty: Actual diets, support participation, departures, contamination and adherence denominators are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Provided exposure, intake and meat restriction, and departures.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Were food provision and actual dietary adherence established?
Application exceptions: Provision targets are not treated as every participant's actual intake or dose.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed

Related sources R01

N09 · How are the 18-month endpoint and persistence after stopping distinguished?

Current findings: The original trial lasted 18 months, and the selected outcome was 18-month MRS intrahepatic-fat change. Persistence, recurrence and longer-term outcomes after the intervention are not separately presented.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. Visit windows, outcomes after stopping exposure and persistence across time periods are unverified.
Reason for missing information: Visit windows, outcomes after stopping exposure and persistence across time periods are unverified.
Required materials and conditions: Intervention duration, outcome visits and additional follow-up
Materials to obtain first: Visit schedules and time-specific and post-treatment material
Further research: Research distinguishing the intervention endpoint from persistent effects
Remaining uncertainty: Visit windows, outcomes after stopping exposure and persistence across time periods are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Intervention duration, outcome visits and additional follow-up.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are the 18-month endpoint and persistence after stopping distinguished?
Application exceptions: 18 months is not recast as guaranteed persistence for everyone or a liver-disease management schedule.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed

Related sources R01

N10 · What were the units and methods for proton-MRS intrahepatic fat?

Current findings: Intrahepatic fat was measured by proton MRS. Preserved figures describe proportional reduction in percent; absolute liver-fat fractions and calculation or measurement specifications are not separately provided.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. MRS equipment and location, eligibility criteria, unit definitions, reproducibility and original absolute measurements are unverified.
Reason for missing information: MRS equipment and location, eligibility criteria, unit definitions, reproducibility and original absolute measurements are unverified.
Required materials and conditions: MRS liver-fat measurement, original units and calculation definitions
Materials to obtain first: MRS measurement and eligibility methods and original value tables
Further research: Intrahepatic-fat research with specified measurement and calculation methods
Remaining uncertainty: MRS equipment and location, eligibility criteria, unit definitions, reproducibility and original absolute measurements are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: MRS liver-fat measurement, original units and calculation definitions.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What were the units and methods for proton-MRS intrahepatic fat?
Application exceptions: Proportional reductions are not recast as absolute fat content, percentage-point change or disappearance of liver fat.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; Internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed

Related sources R01

N11 · How are the three group-specific proportional reductions preserved?

Current findings: Original proportional reductions are green-MED -38.9%, MED -19.6% and HDG -12.2%. These remain group-change descriptions; no new between-group differences, percentage points or effect estimates are calculated.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. Proportional-change formulas, aggregation, group variability, denominators and CIs are unverified.
Reason for missing information: Proportional-change formulas, aggregation, group variability, denominators and CIs are unverified.
Required materials and conditions: Original scope of green-MED -38.9%, MED -19.6% and HDG -12.2%
Materials to obtain first: Group proportional-change definitions, result tables and denominators
Further research: Plans distinguishing within-group changes from between-group effects of interest
Remaining uncertainty: Proportional-change formulas, aggregation, group variability, denominators and CIs are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Original scope of green-MED -38.9%, MED -19.6% and HDG -12.2%.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are the three group-specific proportional reductions preserved?
Application exceptions: -38.9% is not attributed to Mankai alone or presented as a guaranteed personal reduction.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application

Related sources R01

N12 · Were baseline and final absolute liver fat and absolute changes established?

Current findings: The original summary presents only proportional reductions. Baseline and final absolute liver fat, absolute changes, percentage points and absolute between-group effects remain unverified.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been established within the current summary and unread external-material scope. Absolute baseline and final values, changes, units and CIs are unverified.
Reason for missing information: Absolute baseline and final values, changes, units and CIs are unverified.
Required materials and conditions: Baseline and 18-month absolute MRS values, units and changes
Materials to obtain first: Original baseline and final MRS tables, definitions and denominators
Further research: Research specifying absolute and proportional effects of interest together
Remaining uncertainty: Absolute baseline and final values, changes, units and CIs are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Baseline and 18-month absolute MRS values, units and changes.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Were baseline and final absolute liver fat and absolute changes established?
Application exceptions: Absolute liver-fat quantities or percentage points are not reconstructed from original proportional values.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application

Related sources R01

N13 · Which contrast does weight-adjusted P=.035 describe?

Current findings: The weight-loss-adjusted green-MED versus conventional MED comparison is recorded as P=.035. This P value is not treated as the same quantity as original group proportional reductions or effects and CIs for other contrasts.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. Adjusted models, covariates, effect units and estimates, CIs and denominators are unverified.
Reason for missing information: Adjusted models, covariates, effect units and estimates, CIs and denominators are unverified.
Required materials and conditions: Green-MED versus MED adjusted for weight loss
Materials to obtain first: Adjusted models, contrast-specific result tables and the SAP
Further research: Research distinguishing allocation contrasts from adjusted effects of interest
Remaining uncertainty: Adjusted models, covariates, effect units and estimates, CIs and denominators are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Green-MED versus MED adjusted for weight loss.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Which contrast does weight-adjusted P=.035 describe?
Application exceptions: Weight adjustment does not isolate individual components or conclusively establish mechanisms beyond weight change.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application

Related sources R01

N14 · Are other contrasts and unadjusted or adjusted effects kept separate?

Current findings: The current summary specifies a significant P value only for weight-adjusted green-MED versus MED. Exact effects, CIs and P values for green-MED versus HDG, MED versus HDG and unadjusted comparisons are not separately established.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been established within the current summary and unread external-material scope. Other contrasts, unadjusted results, multiplicity handling and CIs are unverified.
Reason for missing information: Other contrasts, unadjusted results, multiplicity handling and CIs are unverified.
Required materials and conditions: Green-MED versus HDG and MED versus HDG, and adjustment status
Materials to obtain first: Analysis tables by contrast and adjustment status
Further research: Research specifying group changes and planned comparisons
Remaining uncertainty: Other contrasts, unadjusted results, multiplicity handling and CIs are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Green-MED versus HDG and MED versus HDG, and adjustment status.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are other contrasts and unadjusted or adjusted effects kept separate?
Application exceptions: The ordering of the three proportional reductions does not establish significance for every between-group comparison.
Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application

Related sources R01

N15 · What numerical scope supports the historical wording of a small standardized effect?

Current findings: The parent text describes a small standardized effect versus conventional MED. Exact standardized values, formulas and CIs are absent from the summary; no new d or effect grade is created.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. Standardized-effect units, definitions, values, CIs and importance thresholds are unverified.
Reason for missing information: Standardized-effect units, definitions, values, CIs and importance thresholds are unverified.
Required materials and conditions: Original small-effect wording and exact standardized values and CIs
Materials to obtain first: Original adjusted and standardized results and importance thresholds
Further research: Research prespecifying the effect of interest, precision and importance
Remaining uncertainty: Standardized-effect units, definitions, values, CIs and importance thresholds are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Original small-effect wording and exact standardized values and CIs.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What numerical scope supports the historical wording of a small standardized effect?
Application exceptions: Original E~, unrecorded precision and small-effect wording are historical values, not current recalculation or regrading results.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is internally designed; M15 §15.3.1–15.3.3; internal application

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N16 · What are the total 294 randomized participants and group denominators?

Current findings: The original total of 294 randomized participants is preserved. Group allocation, MRS analysis and valid contrast-specific denominators are not separately presented in the summary.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. Denominators by group, time point, outcome and adjusted model are unverified.
Reason for missing information: Denominators by group, time point, outcome and adjusted model are unverified.
Required materials and conditions: Total allocation, group allocation and analysis, and time-specific denominators
Materials to obtain first: Participant flow and group-specific and analysis-specific denominator tables
Further research: Research distinguishing allocation from measurement and analysis denominators
Remaining uncertainty: Denominators by group, time point, outcome and adjusted model are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Total allocation, group allocation and analysis, and time-specific denominators.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What are the total 294 randomized participants and group denominators?
Application exceptions: The total is not divided by the number of groups, and participant counts are not newly added or estimated.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

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N17 · Are 89.8% retention, 78% eligible MRS and the original 22% distinguished?

Current findings: The evidence list separately records 89.8% retention at 18 months and 78% eligible follow-up MRS. The original 22% in the parent rationale is preserved as absence of eligible MRS. Retention and imaging eligibility are not presented as the same status.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. Exact denominators for each proportion, group counts and reasons for ineligibility or missingness are unverified.
Reason for missing information: Exact denominators for each proportion, group counts and reasons for ineligibility or missingness are unverified.
Required materials and conditions: Overall follow-up retention, imaging eligibility and original missingness wording
Materials to obtain first: Follow-up retention and imaging eligibility flows with group-specific reasons
Further research: Plans distinguishing clinical follow-up from measurement eligibility
Remaining uncertainty: Exact denominators for each proportion, group counts and reasons for ineligibility or missingness are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Overall follow-up retention, imaging eligibility and original missingness wording.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are 89.8% retention, 78% eligible MRS and the original 22% distinguished?
Application exceptions: Original proportions are not converted into new participant counts or attrition rates, and 22% is not calculated from 89.8%.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design; M08 §8.2.2, M15 §15.3.1; own application; M19 §19.1.2–19.2.4, M04 §4.6.3; own application

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N18 · Are subgroup and baseline liver-fat analysis denominators available?

Current findings: The summary does not provide exact counts or analysis scope showing which baseline liver-fat levels or disease subgroups contributed valid observations to the current findings.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been established within the current summary and unread external-material scope. Subgroup eligibility, group denominators, prespecified plans and interactions are unverified.
Reason for missing information: Subgroup eligibility, group denominators, prespecified plans and interactions are unverified.
Required materials and conditions: Overall MRS population and denominators by subgroup and baseline status
Materials to obtain first: Subgroup analysis tables and baseline and follow-up MRS denominators
Further research: Research distinguishing overall and subgroup effects of interest
Remaining uncertainty: Subgroup eligibility, group denominators, prespecified plans and interactions are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Overall MRS population and denominators by subgroup and baseline status.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are subgroup and baseline liver-fat analysis denominators available?
Application exceptions: The overall 294 participants or 78% are not copied as analysis counts for every subgroup.
Referenced methods: M03 §3.2.1; detailed population conditions are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application

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N19 · Were imaging missingness, eligibility exclusions and analysis populations established?

Current findings: The original text records 78% eligible follow-up MRS and imaging missingness limitations. ITT, complete-case analysis, ineligibility, imputation and sensitivity details are not presented.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. Missingness and eligibility-exclusion reasons, group differences, imputation, sensitivity analyses and analysis populations are unverified.
Reason for missing information: Missingness and eligibility-exclusion reasons, group differences, imputation, sensitivity analyses and analysis populations are unverified.
Required materials and conditions: Reasons for missing MRS, analysis populations, imputation and sensitivity analyses
Materials to obtain first: SAP, imaging eligibility flow and missing-data analyses
Further research: Prespecified plans for imaging missingness and the effect of interest
Remaining uncertainty: Missingness and eligibility-exclusion reasons, group differences, imputation, sensitivity analyses and analysis populations are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Reasons for missing MRS, analysis populations, imputation and sensitivity analyses.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Were imaging missingness, eligibility exclusions and analysis populations established?
Application exceptions: All absent imaging is not recast as attrition or harm events, or treated as zero effect.
Referenced methods: M08 §8.2.2, M15 §15.3.1; Internal application; M08 Table 8.2.a, M04 §4.6.3; Internal application

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N20 · What were three-group randomization, allocation concealment and baseline balance?

Current findings: The original design is a three-arm 18-month randomized lifestyle trial. Actual allocation and concealment methods and baseline balance are not described in detail in the summary.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. Sequence generation, concealment, allocation responsibility and baseline balance are unverified.
Reason for missing information: Sequence generation, concealment, allocation responsibility and baseline balance are unverified.
Required materials and conditions: Random sequence, concealment and three-group baseline information
Materials to obtain first: Allocation procedures, baseline tables and protocol
Further research: Research with explicit three-group allocation, population and effects of interest
Remaining uncertainty: Sequence generation, concealment, allocation responsibility and baseline balance are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Random sequence, concealment and three-group baseline information.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What were three-group randomization, allocation concealment and baseline balance?
Application exceptions: The RCT label and historical parent B1/I1 axes do not certify adequate allocation or absence of bias in a current review.
Referenced methods: M08 §8.1–8.2.3; own application

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N21 · Were MRS masking, standardization and assessment procedures established?

Current findings: Use of proton MRS is preserved, but the summary does not provide assessor or reader masking, equipment and location standardization or reliability over time.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been established within the current summary and unread external-material scope. Measurement, reading, eligibility adjudication, masking and error ranges are unverified.
Reason for missing information: Measurement, reading, eligibility adjudication, masking and error ranges are unverified.
Required materials and conditions: Equipment, reader and time-point masking, and measurement consistency
Materials to obtain first: MRS methods and reading and eligibility procedures
Further research: Research with designated measurement and reading plans
Remaining uncertainty: Measurement, reading, eligibility adjudication, masking and error ranges are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Equipment, reader and time-point masking, and measurement consistency.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Were MRS masking, standardization and assessment procedures established?
Application exceptions: Objective imaging alone does not establish absence of measurement influences or bias.
Referenced methods: M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M08 §§8.1–8.2.3; Chamgap adaptation

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N22 · What were common exposures from baseline disease, medication and lifestyle?

Current findings: The original text records physical activity in all groups and walnuts in both MED groups. Group-specific medication, comorbidity and other lifestyle-change details are not presented.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been established within the current summary and unread external-material scope. Baseline and changed medications, diseases, concurrent exposures and support differences are unverified.
Reason for missing information: Baseline and changed medications, diseases, concurrent exposures and support differences are unverified.
Required materials and conditions: Concurrent treatment, baseline status and common support and activity
Materials to obtain first: Medical history, medication, lifestyle and support records
Further research: Research specifying common exposures and allocation contrasts
Remaining uncertainty: Baseline and changed medications, diseases, concurrent exposures and support differences are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Concurrent treatment, baseline status and common support and activity.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What were common exposures from baseline disease, medication and lifestyle?
Application exceptions: Unknown medications or diseases, or treatment replacement, are not added as original study components.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed

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N23 · Are weight loss, adherence, component contributions and effects of interest distinguished?

Current findings: Similar weight loss in both MED groups and the adjusted direction are preserved as originally described. These are not separated causal findings identifying a particular component or pathway beyond weight change.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. Weight and adherence models, mediation and component-specific effects of interest, and isolated-component comparisons are unverified.
Reason for missing information: Weight and adherence models, mediation and component-specific effects of interest, and isolated-component comparisons are unverified.
Required materials and conditions: Boundaries of weight adjustment, dietary adherence and single-component attribution
Materials to obtain first: Adjustment and adherence material and component-specific designs and analyses
Further research: Research distinguishing the bundled pattern from component and mediation questions
Remaining uncertainty: Weight and adherence models, mediation and component-specific effects of interest, and isolated-component comparisons are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Boundaries of weight adjustment, dietary adherence and single-component attribution.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are weight loss, adherence, component contributions and effects of interest distinguished?
Application exceptions: The adjusted P value and similar weight loss do not certify Mankai or green-tea efficacy alone.
Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.4; internally defined extension boundaries

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N24 · Are registration, outcome hierarchy, reports and prior plans distinguished?

Current findings: The evidence and citation lists record NCT03020186. MRS change in the original classification fields and historical registration-verification wording are preserved, but external registration, protocol and SAP material was not read in this work.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. Registration versions and timing, prespecified outcome hierarchy, analysis and multiplicity plans, and reporting changes are unverified.
Reason for missing information: Registration versions and timing, prespecified outcome hierarchy, analysis and multiplicity plans, and reporting changes are unverified.
Required materials and conditions: NCT03020186 identification, actual plan reading and primary-outcome hierarchy
Materials to obtain first: Registration versions, protocol, SAP and material comparing plans with results
Further research: Research preserving designated outcomes, effects of interest and plan changes
Remaining uncertainty: Registration versions and timing, prespecified outcome hierarchy, analysis and multiplicity plans, and reporting changes are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: NCT03020186 identification, actual plan reading and primary-outcome hierarchy.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are registration, outcome hierarchy, reports and prior plans distinguished?
Application exceptions: Identifiers, original outcome labels and false axis flags alone do not certify prespecified primary status or reading of registration content.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.5–4.6 material collection and selection principles; separation of access and reading and the hyperlink contract are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed

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N25 · How are identities of reports, trials, groups and time points linked?

Current findings: One existing evidence entry and one citation for Yaskolka Meir2021 DIRECT-PLUS are linked as one report. The three groups, 18 months, other time points and sibling questions are not added as new independent trials or participants.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. Relationships among other DIRECT-PLUS reports or populations and totals of unique trials and participants are unverified.
Reason for missing information: Relationships among other DIRECT-PLUS reports or populations and totals of unique trials and participants are unverified.
Required materials and conditions: DIRECT-PLUS report identity and duplicate observations and participants
Materials to obtain first: Identity material linking related reports, trials and participants
Further research: Records distinguishing reports from the same study family
Remaining uncertainty: Relationships among other DIRECT-PLUS reports or populations and totals of unique trials and participants are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: DIRECT-PLUS report identity and duplicate observations and participants.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are identities of reports, trials, groups and time points linked?
Application exceptions: The one currently linked report is not a total count of independent trials or new independence certification.
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

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N26 · Is independent confirmation or direct replication available?

Current findings: The original counterview states that independent confirmation trials are absent, while parent R1/I1 are historical axes. Other studies were not searched for or certified during this production.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been established within the current summary and unread external-material scope. Current external search scope, independent report identities and duplication are unverified.
Reason for missing information: Current external search scope, independent report identities and duplication are unverified.
Required materials and conditions: Independent studies and trial relationships for the same bundled-diet question
Materials to obtain first: Direct replication reports and trial identity material
Further research: Separate confirmation research explicitly addressing the same question
Remaining uncertainty: Current external search scope, independent report identities and duplication are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Independent studies and trial relationships for the same bundled-diet question.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Is independent confirmation or direct replication available?
Application exceptions: Original absence wording is not promoted into a current worldwide absence check, and reports from the same trial are not counted as independent replication.
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

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N27 · Can effects by component, other dietary patterns or subgroup be established?

Current findings: The isolated-component question has grade ? and a note that individual component effects were not separated. Findings from the bundled diet are not attributed to Mankai, green tea or walnuts alone, or to other diets or subgroups.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. Direct effects and CIs for isolated components, other patterns and population-specific comparisons are unverified.
Reason for missing information: Direct effects and CIs for isolated components, other patterns and population-specific comparisons are unverified.
Required materials and conditions: Direct comparisons of the bundled pattern with isolated components or other populations
Materials to obtain first: Direct comparisons of components and other patterns
Further research: Research distinguishing dietary-pattern contrasts from individual-component questions
Remaining uncertainty: Direct effects and CIs for isolated components, other patterns and population-specific comparisons are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Direct comparisons of the bundled pattern with isolated components or other populations.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Can effects by component, other dietary patterns or subgroup be established?
Application exceptions: The advertising example of 39% is not adopted as a new trial figure or component effect.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed

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N28 · Which clinical outcomes does MRS liver fat address?

Current findings: The original text identifies intrahepatic fat as a surrogate and states that clinical liver-disease events are absent. MRS change does not establish direct effects on liver-disease treatment, progression, fibrosis, hospitalization or quality of life.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. Direct clinical events, function, quality of life, follow-up, denominators and CIs are unverified.
Reason for missing information: Direct clinical events, function, quality of life, follow-up, denominators and CIs are unverified.
Required materials and conditions: Surrogates, liver-disease events and patient-important outcomes
Materials to obtain first: Material directly measuring clinical liver-disease outcomes
Further research: Plans distinguishing MRS from clinical events
Remaining uncertainty: Direct clinical events, function, quality of life, follow-up, denominators and CIs are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Surrogates, liver-disease events and patient-important outcomes.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Which clinical outcomes does MRS liver fat address?
Application exceptions: No new liver-disease management or treatment-replacement instructions or disease-event prevention efficacy are created.
Referenced methods: M03 §3.2.4; internally defined extension boundaries

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N29 · What are the boundaries of the original long-term wording, persistence and extrapolation?

Current findings: The parent text describes strengths of the 18-month duration. Findings do not guarantee persistence after stopping, longer follow-up or efficacy in other populations or environments.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. Direct effects after stopping, during longer follow-up and in other populations are unverified.
Reason for missing information: Direct effects after stopping, during longer follow-up and in other populations are unverified.
Required materials and conditions: 18-month results, post-treatment follow-up and other long-term exposures
Materials to obtain first: Long-term, post-treatment and population-specific outcome material
Further research: Research distinguishing persistence from extrapolation questions
Remaining uncertainty: Direct effects after stopping, during longer follow-up and in other populations are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: 18-month results, post-treatment follow-up and other long-term exposures.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What are the boundaries of the original long-term wording, persistence and extrapolation?
Application exceptions: 18 months is not recast as a lifelong management effect or a recommended diet for every liver-disease population.
Referenced methods: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap’s own design; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

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N30 · What original information describes mixed funding and product interests?

Current findings: Original funding wording describes German, Israeli and EU public support, California Walnut Commission support, the PI's disclosed Hinoman advisory role and funders' reported lack of involvement in design or analysis. Original disclosures have not been newly checked externally.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. Original disclosure details, product provision or access, and analysis roles are unverified.
Reason for missing information: Original disclosure details, product provision or access, and analysis roles are unverified.
Required materials and conditions: Public and industry funding, advisory roles and funder involvement
Materials to obtain first: Funding, interests, in-kind contributions and support-role disclosures
Further research: Explicit reporting of funding and decision-making and analysis roles
Remaining uncertainty: Original disclosure details, product provision or access, and analysis roles are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Public and industry funding, advisory roles and funder involvement.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What original information describes mixed funding and product interests?
Application exceptions: Reported non-involvement is not recast as current certification of no interests, and support alone does not lead to a verdict of ineffective treatment.
Referenced methods: Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item; M08 §8.1–8.2.3; internal application

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N31 · What do stored-summary reading, external reading and URL access indicators mean?

Current findings: The complete stored summary for 2984 was read for production and preserved as a copy. The PubMed URL, PMCID and registration identifier are original source links; external content reading, access and link testing were not performed.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. Current checks of external methods, results, registration and material content remain incomplete.
Reason for missing information: Current checks of external methods, results, registration and material content remain incomplete.
Required materials and conditions: Reading scope of the complete stored summary, abstract, full text, registration and needed material
Materials to obtain first: Actually acquired original material and reading and addition-event records
Further research: Production records distinguishing stored summaries from newly acquired material
Remaining uncertainty: Current checks of external methods, results, registration and material content remain incomplete.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Reading scope of the complete stored summary, abstract, full text, registration and needed material.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What do stored-summary reading, external reading and URL access indicators mean?
Application exceptions: The presence of a link, PMCID or NCT identifier is not assigned acquisition, reading or successful-access status.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

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N32 · What are the original Korean and English text, cut-off, empty values and historical axes?

Current findings: Complete Korean and English text, original cut-off 2026-09-07, an empty corrections array and empty deliberation text are preserved. Parent C with 46 points, B/S/R1/I1/E~/B1, unrecorded precision, four false flags and empty override reasons are historical context, not current review or regrading results.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. External detailed translation, corrections and registration comparisons were not performed in this work.
Reason for missing information: External detailed translation, corrections and registration comparisons were not performed in this work.
Required materials and conditions: Original language versions, dates, corrections, axes and parent verdict
Materials to obtain first: Original texts, language-specific changes, dates and correction events
Further research: Separation of original values from new material and changes
Remaining uncertainty: External detailed translation, corrections and registration comparisons were not performed in this work.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Original language versions, dates, corrections, axes and parent verdict.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What are the original Korean and English text, cut-off, empty values and historical axes?
Application exceptions: Historical Codex full-text, registry and scoring verification wording is not inherited as a current passed external reading or content review.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item

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N33 · How were adverse events collected?

Current findings: The original safety explanation states that adverse-event ascertainment was not central to the efficacy report. Actual event definitions, collection methods, scope, severity and event tables are absent from the summary.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been established within the current summary and unread external-material scope. Harm ascertainment and definitions, and complete event findings are unverified.
Reason for missing information: Harm ascertainment and definitions, and complete event findings are unverified.
Required materials and conditions: Event definitions, active or passive collection, severity and denominators
Materials to obtain first: Harm plans, symptom and event tables and discontinuation criteria
Further research: Research with explicit harm ascertainment alongside efficacy
Remaining uncertainty: Harm ascertainment and definitions, and complete event findings are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Event definitions, active or passive collection, severity and denominators.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How were adverse events collected?
Application exceptions: Not being central is not recast as zero adverse events or confirmed absence of actual collection.
Referenced methods: M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP

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N34 · Do nut-allergy and caffeine-sensitivity statements describe actual events?

Current findings: The original text separately mentions nut allergy, caffeine sensitivity and disease-specific dietary suitability. This is not a quantitative or causal finding that a particular event occurred in this trial.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. Enrollment, events, condition-specific denominators and severity in the relevant populations are unverified.
Reason for missing information: Enrollment, events, condition-specific denominators and severity in the relevant populations are unverified.
Required materials and conditions: Original cautionary context distinguished from collected harms
Materials to obtain first: Actual population, harm and relatedness material
Further research: Safety questions specifying the relevant vulnerable scope
Remaining uncertainty: Enrollment, events, condition-specific denominators and severity in the relevant populations are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Original cautionary context distinguished from collected harms.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Do nut-allergy and caffeine-sensitivity statements describe actual events?
Application exceptions: No new intake, product avoidance or recommendation, disease-specific diet or treatment instructions are written.
Referenced methods: M19 §19.1.2–19.2.4; detailed distinctions are internally designed; Internally defined Chamgap interpretation boundaries, referring to M19 principles without applying an official causality tool; M19 §19.1.2–19.2.4; internal application

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N35 · Were group-specific harm events, denominators and comparisons established?

Current findings: The summary lacks group-specific harm events and collection denominators. The total 294 participants, retention and eligible MRS are not automatically used as harm-analysis denominators.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been established within the current summary and unread external-material scope. Harm denominators, effects and CIs by group, event and period are unverified.
Reason for missing information: Harm denominators, effects and CIs by group, event and period are unverified.
Required materials and conditions: Valid harm ascertainment in three groups, event and exposure denominators and effects
Materials to obtain first: Harm flow and arm-specific event/denominator tables
Further research: Research distinguishing efficacy measurements from harm-collection populations
Remaining uncertainty: Harm denominators, effects and CIs by group, event and period are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Valid harm ascertainment in three groups, event and exposure denominators and effects.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Were group-specific harm events, denominators and comparisons established?
Application exceptions: No new zero-event counts, zero incidence, risk differences or CIs are calculated.
Referenced methods: M19 §19.2.2–19.2.4, M03 §3.2.3; internal application; M19 §19.1.2–19.2.4; internal application

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N36 · What were harm timing, exposure duration and delayed follow-up?

Current findings: An 18-month lifestyle trial is described, but the summary lacks harm onset times, repeated exposure and post-treatment or delayed harm observation.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been established within the current summary and unread external-material scope. Harm timing and observation, exposure changes and post-treatment findings are unverified.
Reason for missing information: Harm timing and observation, exposure changes and post-treatment findings are unverified.
Required materials and conditions: Time-specific symptoms and harm observation after discontinuation or study end
Materials to obtain first: Time-specific harm, exposure and follow-up material
Further research: Research with symptom, timing and delayed-observation plans
Remaining uncertainty: Harm timing and observation, exposure changes and post-treatment findings are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Time-specific symptoms and harm observation after discontinuation or study end.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What were harm timing, exposure duration and delayed follow-up?
Application exceptions: 18-month efficacy follow-up is not recast as completed verification of long-term safety.
Referenced methods: M19 §19.2 design-specific harm questions; temporal-relationship details are internally designed; M19 §19.1.2–19.2.4; internal application

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N37 · How is harm attribution handled for the bundled diet, common exposures and medical history?

Current findings: The diet was bundled, with common physical-activity and walnut exposures. Actual causal or relatedness material attributing harms to a particular food or the whole diet was not provided.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been established within the current summary and unread external-material scope. Event-specific exposure, history, concurrent medication, relatedness assessment and alternative causes are unverified.
Reason for missing information: Event-specific exposure, history, concurrent medication, relatedness assessment and alternative causes are unverified.
Required materials and conditions: Food, activity, concurrent medication, disease and event causality
Materials to obtain first: Actual event, exposure, history and relatedness records
Further research: Harm research distinguishing bundled interventions from alternative causes
Remaining uncertainty: Event-specific exposure, history, concurrent medication, relatedness assessment and alternative causes are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Food, activity, concurrent medication, disease and event causality.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How is harm attribution handled for the bundled diet, common exposures and medical history?
Application exceptions: General food-risk warnings are not recast as confirmed causes or events in this trial.
Referenced methods: M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation

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N38 · Are retention, imaging missingness, harms and discontinuation reasons distinguished?

Current findings: Original retention of 89.8% and eligible MRS of 78% are recorded. Harm, motivation and examination-related reasons for each missing or ineligible observation, and harm collection in participants with missing data, remain unverified.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been established within the current summary and unread external-material scope. Group-specific missingness and discontinuation reasons, relationships to harms and collection of missing harm data are unverified.
Reason for missing information: Group-specific missingness and discontinuation reasons, relationships to harms and collection of missing harm data are unverified.
Required materials and conditions: Harm-related discontinuation, missingness and ineligibility reasons, and collection
Materials to obtain first: Participant and imaging flows, discontinuation reasons and harm material
Further research: A plan separating missingness from harm-related discontinuation
Remaining uncertainty: Group-specific missingness and discontinuation reasons, relationships to harms and collection of missing harm data are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Harm-related discontinuation, missingness and ineligibility reasons, and collection.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are retention, imaging missingness, harms and discontinuation reasons distinguished?
Application exceptions: The original 22% is not converted into an adverse-effect rate or a count of participants lost to follow-up.
Referenced methods: M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application

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N39 · Were independent harm studies or separate event material acquired?

Current findings: The current preserved list contains this one efficacy report. Independent original harm material was not searched for or acquired here, and results from the same trial are not counted as a separate harm trial.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been established within the current summary and unread external-material scope. Independent harm-report identity, populations, exposures and duplication are unverified.
Reason for missing information: Independent harm-report identity, populations, exposures and duplication are unverified.
Required materials and conditions: Independent safety material matching the diet, population and exposure
Materials to obtain first: Separate harm studies, surveillance and event reports
Further research: Independent harm research with explicit population and dietary exposure
Remaining uncertainty: Independent harm-report identity, populations, exposures and duplication are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Independent safety material matching the diet, population and exposure.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Were independent harm studies or separate event material acquired?
Application exceptions: Absence of a separate current slot does not establish worldwide absence of harm reports.
Referenced methods: M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations

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N40 · What are the safety boundaries for vulnerable populations, baseline liver disease and long-term exposure?

Current findings: Original wording separately mentions individual disease, dietary suitability, allergy and sensitivity. Safety findings in particular liver-disease subtypes, vulnerable populations or longer exposures are not presented.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been established within the current summary and unread external-material scope. Population-specific history, medication, exposure, direct events and follow-up are unverified.
Reason for missing information: Population-specific history, medication, exposure, direct events and follow-up are unverified.
Required materials and conditions: Subtypes, disease, medication, allergy, sensitivity and long-term observation
Materials to obtain first: Direct harm material for vulnerable and disease-specific populations
Further research: Research specifying population and long-term safety questions
Remaining uncertainty: Population-specific history, medication, exposure, direct events and follow-up are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Subtypes, disease, medication, allergy, sensitivity and long-term observation.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What are the safety boundaries for vulnerable populations, baseline liver disease and long-term exposure?
Application exceptions: No new dietary management, product or intake, weight-management or liver-disease treatment-replacement guidance is produced.
Referenced methods: M19 §19.1.2–19.2.4; Internal application; Design considerations in M19 §19.2.2–19.2.4; Detailed confounding records are internally designed

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N41 · Are liver-fat reduction, unknown safety and causal judgments distinguished?

Current findings: Parent safety is unknown. Liver-fat reduction does not establish comparative safety, clinical liver-disease events or component-specific causal safety.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. Direct comparative events, causality, precision and long-term harm findings are unverified.
Reason for missing information: Direct comparative events, causality, precision and long-term harm findings are unverified.
Required materials and conditions: Efficacy surrogates, original safety and comparative harms
Materials to obtain first: Harm and clinical-event material separate from efficacy
Further research: Research separating safety from surrogate effects of interest
Remaining uncertainty: Direct comparative events, causality, precision and long-term harm findings are unverified.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Efficacy surrogates, original safety and comparative harms.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are liver-fat reduction, unknown safety and causal judgments distinguished?
Application exceptions: Unknown is not recast as zero events, confirmed harm or guaranteed safety.
Referenced methods: Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool; M03 §3.2.4; Internally defined extrapolation boundaries

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N42 · How are later material, condition versions and original values updated?

Current findings: The complete stored summary is preserved and conditions are saved and frozen before separate application. Additional material is linked to events distinguishing absolute and proportional values, adjustment, denominators, populations, comparisons, original values and actual reading.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. Later original material and actual reading or change events are not yet available.
Reason for missing information: Later original material and actual reading or change events are not yet available.
Required materials and conditions: Identity, population, comparator, units, denominators, timing, reading and change events
Materials to obtain first: Additional original material, before and after values and condition-version change records
Further research: Research addressing direct gaps in the selected bundled-diet question
Remaining uncertainty: Later original material and actual reading or change events are not yet available.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Identity, population, comparator, units, denominators, timing, reading and change events.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are later material, condition versions and original values updated?
Application exceptions: Production completion does not establish completed clinical review or publication.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application

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N43 · How are historical candidate records distinguished from current content-review status?

Current findings: Original candidate review-pending and eligibility indicators are preserved. No new model, content or question-boundary review was performed; incomplete review, false completion flags, zero new units and unrecorded final independent counts are retained.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish completed clinical verification or content review. Later review decisions and final independence counts remain unresolved.
Reason for missing information: Later review decisions and final independence counts remain unresolved.
Required materials and conditions: Historical candidate records, production status and new-unit counts
Materials to obtain first: Review and change-decision records
Further research: Records distinguishing the original question, production and review decisions
Remaining uncertainty: Later review decisions and final independence counts remain unresolved.
Conditions for verification: Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Historical candidate records, production status and new-unit counts.
Why this condition is needed: This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are historical candidate records distinguished from current content-review status?
Application exceptions: Historical full-text, registration and scoring verification wording is not invented as a current passed clinical review or external reading.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

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