# Bundled green-MED diet × Eighteen-month MRS intrahepatic-fat reduction Verdict 2984 · Evidence Check Stored-material review date: Not recorded Original evidence cut-off: 2026-09-07 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-15 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - 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 ## Checklist items ### N01 · How are the selected question and the isolated-component question distinguished? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Clinical independence and isolated-component effects have not been newly certified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: The selected subclaim score, status and axes are absent from the original. - 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? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Exact eligibility and exclusion criteria, diagnoses, baseline liver disease, severity and demographic characteristics are unverified. - 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? Verification status: Unverified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Sex, baseline liver fat, subgroup denominators and effects, and interactions are unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Ingredients, preparation and provision, whole-diet and energy targets, and actual adherence details are unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Exercise, common support, walnut adherence and actual exposure differences by group are unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Detailed HDG and MED targets, support, composition and exact contrast-specific effects and CIs are unverified. - 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? Verification status: Unverified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Actual diets, support participation, departures, contamination and adherence denominators are unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Visit windows, outcomes after stopping exposure and persistence across time periods are unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: MRS equipment and location, eligibility criteria, unit definitions, reproducibility and original absolute measurements are unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Proportional-change formulas, aggregation, group variability, denominators and CIs are unverified. - 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? Verification status: Unverified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Absolute baseline and final values, changes, units and CIs are unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Adjusted models, covariates, effect units and estimates, CIs and denominators are unverified. - 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? Verification status: Unverified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Other contrasts, unadjusted results, multiplicity handling and CIs are unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Standardized-effect units, definitions, values, CIs and importance thresholds are unverified. - 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 - Related sources: R01 ### N16 · What are the total 294 randomized participants and group denominators? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Denominators by group, time point, outcome and adjusted model are unverified. - 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 - Related sources: R01 ### N17 · Are 89.8% retention, 78% eligible MRS and the original 22% distinguished? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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%. - Remaining uncertainty: Exact denominators for each proportion, group counts and reasons for ineligibility or missingness are unverified. - 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 - Related sources: R01 ### N18 · Are subgroup and baseline liver-fat analysis denominators available? Verification status: Unverified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Subgroup eligibility, group denominators, prespecified plans and interactions are unverified. - 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 - Related sources: R01 ### N19 · Were imaging missingness, eligibility exclusions and analysis populations established? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Missingness and eligibility-exclusion reasons, group differences, imputation, sensitivity analyses and analysis populations are unverified. - Referenced methods: M08 §8.2.2, M15 §15.3.1; Internal application; M08 Table 8.2.a, M04 §4.6.3; Internal application - Related sources: R01 ### N20 · What were three-group randomization, allocation concealment and baseline balance? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Sequence generation, concealment, allocation responsibility and baseline balance are unverified. - Referenced methods: M08 §8.1–8.2.3; own application - Related sources: R01 ### N21 · Were MRS masking, standardization and assessment procedures established? Verification status: Unverified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Measurement, reading, eligibility adjudication, masking and error ranges are unverified. - Referenced methods: M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M08 §§8.1–8.2.3; Chamgap adaptation - Related sources: R01 ### N22 · What were common exposures from baseline disease, medication and lifestyle? Verification status: Unverified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Baseline and changed medications, diseases, concurrent exposures and support differences are unverified. - 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 - Related sources: R01 ### N23 · Are weight loss, adherence, component contributions and effects of interest distinguished? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Weight and adherence models, mediation and component-specific effects of interest, and isolated-component comparisons are unverified. - 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 - Related sources: R01 ### N24 · Are registration, outcome hierarchy, reports and prior plans distinguished? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Registration versions and timing, prespecified outcome hierarchy, analysis and multiplicity plans, and reporting changes are unverified. - 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 - Related sources: R01 ### N25 · How are identities of reports, trials, groups and time points linked? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Relationships among other DIRECT-PLUS reports or populations and totals of unique trials and participants are unverified. - 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 - Related sources: R01 ### N26 · Is independent confirmation or direct replication available? Verification status: Unverified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Current external search scope, independent report identities and duplication are unverified. - 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 - Related sources: R01 ### N27 · Can effects by component, other dietary patterns or subgroup be established? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Direct effects and CIs for isolated components, other patterns and population-specific comparisons are unverified. - 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 - Related sources: R01 ### N28 · Which clinical outcomes does MRS liver fat address? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Direct clinical events, function, quality of life, follow-up, denominators and CIs are unverified. - Referenced methods: M03 §3.2.4; internally defined extension boundaries - Related sources: R01 ### N29 · What are the boundaries of the original long-term wording, persistence and extrapolation? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Direct effects after stopping, during longer follow-up and in other populations are unverified. - 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 - Related sources: R01 ### N30 · What original information describes mixed funding and product interests? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Original disclosure details, product provision or access, and analysis roles are unverified. - 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 - Related sources: R01 ### N31 · What do stored-summary reading, external reading and URL access indicators mean? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Current checks of external methods, results, registration and material content remain incomplete. - 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 - Related sources: R01 ### N32 · What are the original Korean and English text, cut-off, empty values and historical axes? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: External detailed translation, corrections and registration comparisons were not performed in this work. - 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 - Related sources: R01 ### N33 · How were adverse events collected? Verification status: Unverified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Harm ascertainment and definitions, and complete event findings are unverified. - Referenced methods: M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP - Related sources: R01 ### N34 · Do nut-allergy and caffeine-sensitivity statements describe actual events? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Enrollment, events, condition-specific denominators and severity in the relevant populations are unverified. - 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 - Related sources: R01 ### N35 · Were group-specific harm events, denominators and comparisons established? Verification status: Unverified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Harm denominators, effects and CIs by group, event and period are unverified. - Referenced methods: M19 §19.2.2–19.2.4, M03 §3.2.3; internal application; M19 §19.1.2–19.2.4; internal application - Related sources: R01 ### N36 · What were harm timing, exposure duration and delayed follow-up? Verification status: Unverified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Harm timing and observation, exposure changes and post-treatment findings are unverified. - Referenced methods: M19 §19.2 design-specific harm questions; temporal-relationship details are internally designed; M19 §19.1.2–19.2.4; internal application - Related sources: R01 ### N37 · How is harm attribution handled for the bundled diet, common exposures and medical history? Verification status: Unverified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Event-specific exposure, history, concurrent medication, relatedness assessment and alternative causes are unverified. - 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 - Related sources: R01 ### N38 · Are retention, imaging missingness, harms and discontinuation reasons distinguished? Verification status: Unverified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Group-specific missingness and discontinuation reasons, relationships to harms and collection of missing harm data are unverified. - 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 - Related sources: R01 ### N39 · Were independent harm studies or separate event material acquired? Verification status: Unverified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Independent harm-report identity, populations, exposures and duplication are unverified. - 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 - Related sources: R01 ### N40 · What are the safety boundaries for vulnerable populations, baseline liver disease and long-term exposure? Verification status: Unverified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Population-specific history, medication, exposure, direct events and follow-up are unverified. - 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 - Related sources: R01 ### N41 · Are liver-fat reduction, unknown safety and causal judgments distinguished? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - Current findings: Parent safety is unknown. Liver-fat reduction does not establish comparative safety, clinical liver-disease events or component-specific causal safety. - 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 - 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. - Remaining uncertainty: Direct comparative events, causality, precision and long-term harm findings are unverified. - Referenced methods: Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool; M03 §3.2.4; Internally defined extrapolation boundaries - Related sources: R01 ### N42 · How are later material, condition versions and original values updated? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Later original material and actual reading or change events are not yet available. - 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 - Related sources: R01 ### N43 · How are historical candidate records distinguished from current content-review status? Verification status: Partly verified Reading scope: Summary read; external materials unread, access not attempted - 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. - 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 - 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. - Remaining uncertainty: Later review decisions and final independence counts remain unresolved. - 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 ## Evidence and sources ### 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](https://pubmed.ncbi.nlm.nih.gov/33461965/) Materials actually read: Summary read; external materials unread, access not attempted Findings recorded in the 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. 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. | 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. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · 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/materials 1.0. Public pages and materials were prepared from the existing 43 items. No new clinical search, verification-status change or scoring was performed.