Camu-camu fruit extract · 12-week MRI liver fat — Evidence Check

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Efficacy, boundaries and materialsWhat is the selected subclaim and its original record?Required	The selected existing subclaim is reduced MRI liver fat at 12 weeks; its original verdict record is distinguished from the question. The parent question concerns reduced 12-week liver fat in overweight adults with elevated triglycerides. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Independent-claim status was not certified. The single existing subclaim is not newly split and no hypothetical main claim is created.	Original Korean/English wording and the question/record relationship for reduced 12-week MRI liver fat	If the question boundary changes, retain the original wording separately from the change event.
2	Partly verified	Full text not readStored summary read	N02 · Efficacy, boundaries and materialsHow are the subclaim C and parent C54, axes and history distinguished?Required	Subclaim C and the note that the relative difference was -15.85%, P=0.003, but the endpoint was an imaging surrogate are retained. Subclaim score/status/axes keys are absent. Parent C54/Caution and B/S/R1/I2/E+/B2, with precision not recorded, are parent context. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Subclaim score, status and axes remain unrecorded. Parent scores or historical cross-checks are not assigned as current subclaim review or verdict values.	Subclaim grade/note, absence of score/status/axes and preservation of parent values	When a separate evidence-update event occurs, distinguish preservation of original values from the new decision.
3	Partly verified	Full text not readStored summary read	N03 · Efficacy, boundaries and materialsWhich selected adult population was actually studied?Required	The original study was a camu-camu/placebo sequence crossover trial in 35 overweight adults with elevated fasting triglycerides. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Numeric BMI/triglyceride thresholds, age/sex, liver-disease diagnosis, baseline HFF, metabolic conditions and detailed inclusion/exclusion criteria are absent from the summary.	Eligibility and baseline liver fat in overweight adults with elevated fasting triglycerides	Distinguish applicability to other populations using direct eligibility and baseline-characteristic materials.
4	Partly verified	Full text not readStored summary read	N04 · Efficacy, boundaries and materialsWhat was the tested extract?Required	Camu-camu is Myrciaria dubia fruit extract. The original safety account records gastrointestinal discomfort possibly related to capsules. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Extract standardization, raw-material equivalents, vitamin C/polyphenol quantification, manufacturer/batches, capsule count and composition are unverified.	Actual formulation, quantification and manufacture of Myrciaria dubia fruit extract	Distinguish other camu-camu products when actual composition/formulation and direct materials are available.
5	Partly verified	Full text not readStored summary read	N05 · Efficacy, boundaries and materialsWhat were the research exposure and actual implementation?Required	The original trial used camu-camu fruit extract at 1.5 g/day for 12 weeks. This preserves the research exposure. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Individual intake/adherence, discontinuation/dose reduction, capsule composition and direct comparisons with other doses are unverified.	Research exposure of 1.5 g/day for each 12-week period and actual adherence	Link follow-up materials while distinguishing nominal exposure from actual exposure.
6	Partly verified	Full text not readStored summary read	N06 · Efficacy, boundaries and materialsWhat was in the placebo and which comparison was made?Required	The original double-blind crossover trial compared camu-camu with placebo. The relative-change contrast is camu-camu versus placebo. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Placebo ingredients, calories, formulation, matching appearance/taste and actual delivery differences are absent from the summary.	Placebo composition/appearance, masking and treatment comparison	Do not automatically combine materials using a different control into the same contrast.
7	Partly verified	Full text not readStored summary read	N07 · Efficacy, boundaries and materialsHow are intervention periods and washout distinguished?Required	The original account describes each 12-week exposure followed by crossover after washout. The selected result concerns 12-week MRI liver fat. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Washout length, total actual participation duration, visit windows and measurement timing between interventions are unverified.	Each 12-week period, crossover after washout and actual schedule	When timing materials become available, link baseline/end measurements separately for each period.
8	Partly verified	Full text not readStored summary read	N08 · Efficacy, boundaries and materialsWhat were crossover allocation and comparison units?Required	The double-blind crossover trial randomized 35 participants to camu-camu/placebo sequence. Thirty completed both periods. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Sequence-specific allocation counts, allocation generation/concealment and actual intervention switching are unverified.	Randomized intervention sequence and repeated comparison in the same participants	Retain distinctions between sequence, period and the same participants in new reports.
9	Partly verified	Full text not readStored summary read	N09 · Efficacy, boundaries and materialsAre the actual roles and maintenance of double blinding known?Required	The original design was recorded as double-blind. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Who was blinded, product distinguishability, MRI reader/analyst masking and unmasking timing are unverified because external materials remain unread.	Masking/unmasking of participants, assessors and analysts	Distinguish the double-blind label from actual roles and procedures in additional materials.
10	Unverified	Full text not readStored summary read	N10 · Efficacy, boundaries and materialsWhat accompanying diet, weight and medication changes occurred?Required	The preserved summary describes only camu-camu/placebo sequence comparison and liver-fat change. R01	Required direct definitions, values and materials are unverified within the current preserved-summary/unread-external scope. Diet, alcohol, exercise, medication, weight change, common management and period-specific differences are unverified.	Period-specific co-exposure, weight changes and medication/behavior conditions	Retain actual measurement/adjustment of accompanying changes together with extract exposure in follow-up research.
11	Partly verified	Full text not readStored summary read	N11 · Efficacy, boundaries and materialsHow was MRI liver fat actually measured?Required	The original evidence-list endpoint was change from baseline in MRI hepatic fat fraction. Results were recorded as imaging HFF. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. MRI technique/equipment, reading, reproducibility, detailed fat-fraction definition and unit handling are unverified.	MRI hepatic fat fraction, change from baseline and equipment/methods	When methods are supplied, link actual technique, units and reading scope to the result.
12	Partly verified	Full text not readStored summary read	N12 · Efficacy, boundaries and materialsAre five regions of interest distinguished from participant counts?Required	The original research account states that mean HFF from five MRI regions per participant was used for the prespecified hepatic-steatosis analysis. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Region locations/selection, missing regions, averaging and valid measurement criteria per participant are unverified.	Mean MRI regions of interest per participant and analysis unit	Distinguish regions, averages and participant-level analysis units in new measurement reports.
13	Partly verified	Full text not readStored summary read	N13 · Efficacy, boundaries and materialsAre relative change from baseline and final HFF distinguished?Required	The endpoint was change from baseline in MRI HFF; the original reader answer describes relative change. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Period-specific baseline HFF, final absolute HFF, change dispersion and the original definition of relative-change calculation are absent from the summary.	Period-specific baseline, change, relative/absolute measures and final values	Link baseline, final values, absolute change and relative change separately when result tables are added.
14	Partly verified	Full text not readStored summary read	N14 · Efficacy, boundaries and materialsWhat were the original relative changes by period?Required	Preserved relative MRI liver-fat changes were -7.43% with camu-camu versus +8.42% with placebo. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Dispersion/intervals for each relative change, period baselines and links to actual analysis participants are unverified.	Attribution of -7.43% to camu-camu and +8.42% to placebo	When original results are supplemented, link each period/measure and preserve current original values.
15	Partly verified	Full text not readStored summary read	N15 · Efficacy, boundaries and materialsWhich contrast does the original -15.85% relative difference represent?Required	The original between-treatment relative difference was -15.85%, P=0.003. The summary explicitly describes a relative-change contrast, not a 15.85-percentage-point absolute reduction. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Exact paired estimand, model, adjustment, sequence/period handling and effect interval are unverified.	Between-treatment contrast in relative change from baseline and P value	When analysis materials arrive, link the relative-change contrast and original adjustment to that analysis.
16	Partly verified	Full text not readStored summary read	N16 · Efficacy, boundaries and materialsHow is the approximately 1.6-percentage-point median absolute HFF decrease retained?Required	The preserved median absolute HFF decrease was approximately 1.6 percentage points. The original summary states that it should be presented alongside the relative difference. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. The exact population, period, contrast definition, interval, dispersion and baseline for this median are unverified.	Absolute-change median, population/contrast and separate relative-measure labeling	When materials are added, link the original median to its actual population, measure and interval.
17	Partly verified	Full text not readStored summary read	N17 · Efficacy, boundaries and materialsWhat is the scope of the account that the effect CI was unreported?Required	The original result, reader answer and synthesis recorded that the treatment-effect CI was unreported. This historical account is retained. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. External result tables, supplements and interval reporting were not read here. Nonreporting across all current materials was not newly verified.	Original unreported-CI record and actual external reading scope	Link supplied intervals with their actual original location, measure and analysis while preserving the original record.
18	Partly verified	Full text not readStored summary read	N18 · Efficacy, boundaries and materialsWhat was the clinically important HFF threshold?Required	The original rationale states that a prespecified clinically important between-treatment HFF threshold was unreported. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Validated thresholds for that population/measure and original planning materials were not read here.	Prespecified importance criterion, measure and uncertainty	When direct criteria are supplied, distinguish prespecified/post hoc status, measure and applicable population.
19	Partly verified	Full text not readStored summary read	N19 · Efficacy, boundaries and materialsWhich denominators are 35 allocated and 30 completing both periods?Required	The original evidence record states 35 randomized and 30 completing both periods analyzed. These numbers describe allocation and completion of both periods. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Sequence-specific completer counts, period-specific discontinuation/withdrawal and completion definitions are unverified.	Allocation, sequence, period completion and completer analysis	When flow is supplemented, record allocation, each-period completion and both-period completion separately.
20	Partly verified	Full text not readStored summary read	N20 · Efficacy, boundaries and materialsHow do the MRI analysis counts of 20 and 25 differ?Required	The original research account and grade rationale specify 20 in the camu-camu period and 25 in the placebo period for primary MRI liver-fat analysis, distinct from 30 completing both periods. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Number of the same participants with MRI in both periods, sequence-specific n, valid paired data and missingness reasons are unverified.	Actual endpoint denominators of 20 in the camu-camu period and 25 in the placebo period	Link completer counts separately from actual endpoint-analysis denominators in new analysis materials.
21	Partly verified	Full text not readStored summary read	N21 · Efficacy, boundaries and materialsHow were completion, MRI selection and missingness handled?Required	The parent summary identifies analysis of 30 completers from 35 randomized and period-specific MRI counts of 20/25 as key limitations of the positive result. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Reasons for MRI nonmeasurement/exclusion, whole-randomized-population analysis, imputation, missingness assumptions and sensitivity analyses are unverified.	Completer analysis, missing MRI, missingness reasons/handling and sensitivity	Retain reasons/assumptions for differences between all allocated participants and actual outcome analysis in follow-up research.
22	Partly verified	Full text not readStored summary read	N22 · Efficacy, boundaries and materialsHow were sequence, period and carryover effects handled?Required	The original study crossed over after washout. Actual analysis is summarized as a treatment contrast in relative HFF change. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Carryover assessment, sequence/period effects, paired correlation, model, adjustment and assumptions are unverified.	Crossover model, washout, sequence/period/carryover effects and correlation	Link both periods in the same participants and report carryover/period assumptions separately in crossover analysis materials.
23	Partly verified	Full text not readStored summary read	N23 · Efficacy, boundaries and materialsWhat was the hierarchy of the prespecified MRI endpoint and other outcomes?Required	The preserved research account records prespecified hepatic-steatosis analysis using mean HFF from five regions and the primary MRI endpoint. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Original plan dates/definitions, multiplicity and hierarchy of other liver-injury/microbiome results are unverified because external materials remain unread.	Hepatic-steatosis planning, primary MRI and other markers	When plans are supplied, distinguish actual prespecified/post hoc and primary/supporting results.
24	Partly verified	Full text not readStored summary read	N24 · Efficacy, boundaries and materialsWhat is the status of NCT04130321 and the current original registration?Required	NCT04130321 appears in the original evidence registration field and research account. It is preserved as registration identity. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Registration full text/date, change history, current recruitment/result disclosure and endpoint correspondence were not newly checked. The citation has no separate registration-number key.	Original registration identity, planning/change history and actual reading	Distinguish the original number, historical records and current reading scope when registration materials are supplied.
25	Partly verified	Full text not readStored summary read	N25 · Efficacy, boundaries and materialsWhat are the report identity and actual preserved-summary locations?Required	R01 is the Marette A et al. camu-camu randomized crossover report, Cell Rep Med 2024;5:101682, PMID 39168095, linked to original evidence and citation records. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. DOI, PMCID and current external bibliography/full-text locations are unspecified in this summary and were not looked up here.	Marette 2024, Cell Reports Medicine, PMID and original evidence/citation records	When bibliography is supplemented, retain original literal wording together with the change event.
26	Partly verified	Full text not readStored summary read	N26 · Efficacy, boundaries and materialsAre the same trial, periods and regions kept separate from new independent replication?Required	The original summary contains one evidence record, one citation and one existing subclaim. Period crossover in the same participants and averaging regions belong to the same trial result structure. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Unique trial/participant totals were not newly certified or summed during preparation. No new direct independent-replication materials were sought.	Same crossover population, two periods, regions of interest and report family	Distinguish recruitment, registration and participant relationships when new independent materials are supplied.
27	Partly verified	Full text not readStored summary read	N27 · Efficacy, boundaries and materialsAre MRI reduction and actual liver-disease outcomes distinguished?Required	The original crux/product facts explicitly distinguish MRI liver fat as an imaging surrogate from clinical events such as cirrhosis, hospitalization or death. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Direct long-term fibrosis, cirrhosis, hospitalization, death, symptom and quality-of-life outcomes are unverified within the preserved scope.	Imaging surrogate versus cirrhosis, hospitalization, death and other clinical events	Link new clinical outcomes with definitions, timing and denominators separate from MRI.
28	Partly verified	Full text not readStored summary read	N28 · Efficacy, boundaries and materialsWhat are the product, duration and ingredient boundaries?Required	The original counterview describes differing green-tea, curcumin, resveratrol and hesperidin results and rejects generalization to polyphenol efficacy. The verdict is limited to this extract, dose, duration and MRI endpoint. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Direct comparisons of other camu-camu products, isolated ingredients, doses/durations, populations/diseases and long-term maintenance are unverified.	Tested extract, 1.5 g/day, 12 weeks and other polyphenols	Distinguish replication of the same question from applicability to different ingredients/products in independent follow-up research.
29	Partly verified	Full text not readStored summary read	N29 · Efficacy, boundaries and materialsWhat is the scope of opposing, conflicting and individual-difference materials?Required	The summary retains a single small positive imaging result alongside completer/MRI denominator limitations. Differences between other polyphenols provide context for separate questions. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Other direct trials for the same camu-camu question, individual responses and sequence/sex/baseline-liver-fat subgroup results were not sought or checked here.	Positive result, uncertainty and differences between ingredients/subgroups	Distinguish actual conflict for the same question from differences between ingredients/measures in new materials.
30	Partly verified	Full text not readStored summary read	N30 · Efficacy, boundaries and materialsWhich original records describe support and industry relationships?Required	The original record describes Weston Family Microbiome Initiative/CIHR support and unreported manufacturer funding, free product, commercial analysis, writing and publication costs. It records A. Marette’s Pfizer/CIHR joint research chair and Y. Desjardins’s NSERC–Diana Food industrial research chair disclosures. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Original contracts, supply details, current relationships and company analysis/publication roles remain unread. No separate sponsor name appears in the summary.	Nonprofit/public support, manufacturer-reporting status and research-chair disclosures	Distinguish direct support, external relationships and analysis/publication roles in newly disclosed materials.
31	Partly verified	Full text not readStored summary read	N31 · Efficacy, boundaries and materialsHow are original dates, corrections, empty values, Korean/English wording and history preserved?Required	The original verified date is 2026-08-26; corrections are an empty array and deliberation an empty string. Korean/English wording, synthesis, grade-decision records, axes and false flags are preserved in the complete summary. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Separate facets and primary-failed/secondary-positive keys are absent. Empty corrections do not establish a current external correction/retraction check.	2026-08-26, empty correction/deliberation records and original verdict/axes	When materials change, record the complete earlier text, event, version and separate application distinctly.
32	Partly verified	Full text not readStored summary read	N32 · Efficacy, boundaries and materialsWhat was actually read and what are the material-slot states?Required	Preparation read the complete 2966 summary and its selected existing subclaim. One report’s summary-read slot is distinguished from unread external/required-material slots. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. External abstract, full text, registration, protocol, SAP, supplementary results/harms and support declarations were not accessed or obtained.	Distinction between preserved summary and external abstract, full text, registration and plans	When materials are supplied, separately record acquisition, publication, access, actual reading scope and dates.
33	Partly verified	Full text not readStored summary read	N33 · Efficacy, boundaries and materialsWhat should be linked when new evidence or corrections arrive?Required	Preparation transfers the existing question and original verdict into the same seven-column format. Conditions were saved/frozen before writing at a separate application time. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. No new clinical search, calculation, regrading, effect/CI, independence certification or model/self content review was performed.	Separation of conditions, original materials, observations, reading and change events	Only for new materials and actual changes, distinguish complete earlier files, events, condition version/freeze, separate application and current handoff.
34	Partly verified	Full text not readStored summary read	H01 · HarmsHow were gastrointestinal discomfort and adverse events defined and collected?Supporting harm information	The original safety account records one participant discontinuing for mild gastrointestinal discomfort considered possibly capsule-related. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Adverse-event definitions, severity criteria, collection methods, relatedness adjudication and complete event lists are unverified.	Mild gastrointestinal discomfort, relatedness and adverse-event collection/grading	Retain consistent collection/grading for gastrointestinal events and other harms in follow-up research.
35	Partly verified	Full text not readStored summary read	H02 · HarmsWhat were actual event timing and exposure?Supporting harm information	The original harms record concerns possibly capsule-related gastrointestinal discomfort leading to discontinuation in the crossover trial. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Which intervention/sequence/period, onset/discontinuation timing, actual exposure and postdiscontinuation follow-up are unverified.	Intervention period, washout/switching and onset/discontinuation timing	Distinguish event periods, actual exposure at risk and postdiscontinuation course in harms reports.
36	Partly verified	Full text not readStored summary read	H03 · HarmsAre harms compared by camu-camu/placebo period?Supporting harm information	The parent summary describes a safety-data gap because systematic adverse-event tables and arm-specific serious-event counts were absent. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Current external tables remain unread. Complete period-specific adverse events, serious events and intervals are unverified.	Period-specific events, relatedness, severity and control comparison	When actual harms materials are added, link period-specific exposure in the same participants to original definitions.
37	Partly verified	Full text not readStored summary read	H04 · HarmsHow do withdrawal and harms denominators differ?Supporting harm information	The original summary states that one of five withdrawals followed mild gastrointestinal discomfort possibly capsule-related. This harms record is separate from allocation of 35, completion of 30 and MRI counts of 20/25. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Other withdrawal reasons, period-specific harms-exposure n, collection/analysis denominators and repeated event counts are unverified.	Original five withdrawals, one gastrointestinal-discomfort withdrawal and actual safety population	Distinguish allocation, exposure, period-specific collection and analysis denominators in harms materials.
38	Partly verified	Full text not readStored summary read	H05 · HarmsWhat level of signal does possible capsule relatedness represent?Supporting harm information	The original record is a case of discontinuation for mild gastrointestinal discomfort considered possibly capsule-related. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Diagnosis, accompanying food/medication, background symptoms, rechallenge, independent relatedness review and confirmed cause are unverified.	Discomfort timing, alternative factors and possible-relatedness judgment	Distinguish a possible-relatedness signal from direct causal judgment in additional harms materials.
39	Unverified	Full text not readStored summary read	H06 · HarmsAre unread, unreported, uncollected and actual zero outcomes distinguished?Supporting harm information	The original summary records absent systematic adverse-event tables and arm-specific serious-event counts. External papers/supplements were not read here. R01	Required direct definitions, values and materials are unverified within the current preserved-summary/unread-external scope. Actual distinctions in current external originals between uncollected, unreported, missing and zero events are unverified.	Unread external scope and gaps in harms results	Link actual zero, missing, unreported and uncollected states separately only for supplied materials.
40	Partly verified	Full text not readStored summary read	H07 · HarmsAre crossover harms and reports protected from duplicate summing?Supporting harm information	The crossover trial in this summary is one report in which the same participants undergo camu-camu and placebo periods. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Duplicate/repeated relationships of participants/events by sequence and period and new independent harms materials are unverified.	Harms linkage in the same participants across two periods and one report	Distinguish rereporting of the same event from new events when harms materials are supplemented.
41	Partly verified	Full text not readStored summary read	H08 · HarmsWhat gaps remain in long-term safety and other risk populations?Supporting harm information	Parent safety is Caution. The original question concerns MRI liver-fat change with a specific extract and research exposure. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Direct harms from longer exposure, other doses/formulations, liver-disease severity, vulnerable populations and drug interactions were not checked here.	12-week research exposure and safety for longer periods, other formulations/populations/diseases	Retain actual exposure, population, duration and collection methods in long-term safety research.
42	Partly verified	Full text not readStored summary read	H09 · HarmsAre limitations of imaging benefits and harms signals retained together?Supporting harm information	The selected original MRI result is grade C/positive, alongside small-crossover/completer/MRI denominator limitations, a gastrointestinal-discomfort case and harms-data gaps. R01	Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. No new benefit–harm synthesis, clinical treatment selection or usage guidance was created.	Separation of positive MRI, uncertainty, gastrointestinal discomfort and systematic-harms gaps	When new materials are supplied, link imaging, clinical and harms results and their change events separately.

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42 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: Overweight adults with elevated fasting triglycerides. Diagnosis, numeric eligibility thresholds, baseline HFF and detailed characteristics are unverified.
Ingredient, formulation and route: Camu-camu fruit extract, 1.5 g/day
Dose: Original extract exposure of 1.5 g/day for each 12-week intervention period. Ingredient quantification, raw-material equivalents and actual adherence are unverified; this is not usage guidance.
Comparator: Placebo sequence crossover. Placebo composition, actual masking and accompanying management details are unverified.
Measured outcome: Change from baseline in MRI hepatic fat fraction. Relative changes were -7.43% versus +8.42%; the original relative difference was -15.85%, P=0.003. Approximately 1.6 percentage points as the median absolute HFF decrease is a separate measure. The original record of unreported treatment-effect CI is retained.
Duration: Each 12-week intervention followed by crossover after washout. Washout length, total actual duration and visit windows are unverified.
Questions outside this scope: Transferring the 30 completers wholesale into actual MRI analysis denominators of 20/25; Turning the -15.85% relative difference into a 15.85-percentage-point absolute decrease; Defining the approximately 1.6-percentage-point median as a new adjusted between-treatment mean difference or relative-difference conversion; Summing participants or independent trials across periods, regions of interest and parent/subclaim sheets; Extending MRI imaging results to cirrhosis, hospitalization, death or long-term treatment/prevention efficacy; Generalizing efficacy/safety to other polyphenols, products, ingredients, doses or durations; Implementation guidance for product intake/usage, diet, liver-disease management or treatment replacement

Evidence and sources

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

R01 · Marette A, et al. Camu-camu decreases hepatic steatosis and liver injury markers in overweight, hypertriglyceridemic individuals: a randomized crossover trial. Cell Rep Med. 2024;5:101682. PMID: 39168095.

PubMed

Material type: Double-blind randomized placebo-controlled crossover report
Materials actually read: Summary read; external materials not read
Findings recorded in the stored summary: -7.43% versus +8.42%; relative difference -15.85%, P=0.003; median absolute HFF decrease approximately 1.6 percentage points; CI unreported. The original 30 completers are distinguished from actual MRI analysis of 20 in the camu-camu period and 25 in the placebo period. Relative difference is not converted into percentage-point absolute decrease.
Record level: Preserved first evidence record and complete parent summary
Study overlap and independent replication: Single preserved-summary crossover population of Marette 2024/NCT04130321. The same participants’ periods, regions, allocation of 35, completion of 30, MRI counts of 20/25 and parent/subclaim sheets are not summed into new independent trials or participants.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Local preserved summary	Local copy acquired	Summary read	The corresponding bibliography, results, MRI denominators and harms context in the complete 2966 preserved summary were read. This is not external-paper reading.
External abstract	Current publication/access unverified	Access not attempted; not obtained	Not read	Only the preserved-summary citation link is connected. Abstract content or successful current access was not confirmed.
External full text	Current publication/access unverified	Access not attempted; not obtained	Not read	Only the preserved bibliographic-identity link is connected. Full-text location, publication and access are unverified.
Registration	Current publication/access unverified	Access not attempted; not obtained	Not read	The original registration number is preserved; current content, dates and endpoint correspondence remain unread.
Protocol	Current publication/access unverified	Access not attempted; not obtained	Not read	Required-material slot. Actual file existence/publication, washout and MRI plans are unverified.
Statistical analysis plan	Current publication/access unverified	Access not attempted; not obtained	Not read	Required-material slot. Actual sequence, period, carryover, paired/missingness and estimand plans are unverified.
Results, denominator and harm details	Current publication/access unverified	Access not attempted; not obtained	Not read	Slot requiring original tables linking actual MRI counts of 20/25 with 30 completers, intervals, absolute median and period-specific harms.
Support and interests	Current publication/access unverified	Access not attempted; not obtained	Not read	Historical support, nonreporting and research-chair disclosure accounts in the preserved summary are distinguished from current external original declarations.

Report counts versus independent study counts

Single preserved-summary crossover population of Marette 2024/NCT04130321. The same participants’ periods, regions, allocation of 35, completion of 30, MRI counts of 20/25 and parent/subclaim sheets are not summed into new independent trials or participants.

Review criteria

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

N01 · What is the selected subclaim and its original record?

Required materials and conditions: Original Korean/English wording and the question/record relationship for reduced 12-week MRI liver fat
Conditions for verification: Link original Korean/English wording and the question/record relationship for reduced 12-week MRI liver fat to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Do not turn parent/subclaim overlap into new independent trials or additional structural units.
Why this condition is needed: Preparation condition retaining the actual scope of original Korean/English wording and the question/record relationship for reduced 12-week MRI liver fat.
Referenced methods: Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design

N02 · How are the subclaim C and parent C54, axes and history distinguished?

Required materials and conditions: Subclaim grade/note, absence of score/status/axes and preservation of parent values
Conditions for verification: Link subclaim grade/note, absence of score/status/axes and preservation of parent values to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: C54, B2 and historical cross-checks are preserved history, not new score calculation, RoB execution or completed content review.
Why this condition is needed: Preparation condition retaining the actual scope of subclaim grade/note, absence of score/status/axes and preservation of parent values.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

N03 · Which selected adult population was actually studied?

Required materials and conditions: Eligibility and baseline liver fat in overweight adults with elevated fasting triglycerides
Conditions for verification: Link eligibility and baseline liver fat in overweight adults with elevated fasting triglycerides to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Fatty-liver/MASLD tag names alone do not establish every participant’s diagnosis or severity.
Why this condition is needed: Preparation condition retaining the actual scope of eligibility and baseline liver fat in overweight adults with elevated fasting triglycerides.
Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap's own design

N04 · What was the tested extract?

Required materials and conditions: Actual formulation, quantification and manufacture of Myrciaria dubia fruit extract
Conditions for verification: Link actual formulation, quantification and manufacture of Myrciaria dubia fruit extract to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Do not convert 1.5 g of extract into 1.5 g of vitamin C, fruit raw-material quantity or equivalents of other products.
Why this condition is needed: Preparation condition retaining the actual scope of actual formulation, quantification and manufacture of Myrciaria dubia fruit extract.
Referenced methods: M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design

N05 · What were the research exposure and actual implementation?

Required materials and conditions: Research exposure of 1.5 g/day for each 12-week period and actual adherence
Conditions for verification: Link research exposure of 1.5 g/day for each 12-week period and actual adherence to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: No intake, capsule-count, dose-conversion, product-selection or treatment-implementation guidance is written.
Why this condition is needed: Preparation condition retaining the actual scope of research exposure of 1.5 g/day for each 12-week period and actual adherence.
Referenced methods: M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed

N06 · What was in the placebo and which comparison was made?

Required materials and conditions: Placebo composition/appearance, masking and treatment comparison
Conditions for verification: Link placebo composition/appearance, masking and treatment comparison to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Prepare only the preserved-summary scope without adding definitions, values or denominators absent from original materials.
Why this condition is needed: Preparation condition retaining the actual scope of placebo composition/appearance, masking and treatment comparison.
Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

N07 · How are intervention periods and washout distinguished?

Required materials and conditions: Each 12-week period, crossover after washout and actual schedule
Conditions for verification: Link each 12-week period, crossover after washout and actual schedule to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Do not add the two 12-week periods into a new total duration or claim that everyone completed identical total exposure.
Why this condition is needed: Preparation condition retaining the actual scope of each 12-week period, crossover after washout and actual schedule.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP; Design-specific harm questions in M19 §19.2; Detailed temporal relationships are internally designed

N08 · What were crossover allocation and comparison units?

Required materials and conditions: Randomized intervention sequence and repeated comparison in the same participants
Conditions for verification: Link randomized intervention sequence and repeated comparison in the same participants to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Do not count camu-camu and placebo periods as independent parallel groups or two trials.
Why this condition is needed: Preparation condition retaining the actual scope of randomized intervention sequence and repeated comparison in the same participants.
Referenced methods: M08 §8.1–8.2.3; CHAMGAP adaptation; Distinction between studies and reports in M04 §4.6.1–4.6.2; Cohort/outcome connections are CHAMGAP adaptations

N09 · Are the actual roles and maintenance of double blinding known?

Required materials and conditions: Masking/unmasking of participants, assessors and analysts
Conditions for verification: Link masking/unmasking of participants, assessors and analysts to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Prepare only the preserved-summary scope without adding definitions, values or denominators absent from original materials.
Why this condition is needed: Preparation condition retaining the actual scope of masking/unmasking of participants, assessors and analysts.
Referenced methods: M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application

N10 · What accompanying diet, weight and medication changes occurred?

Required materials and conditions: Period-specific co-exposure, weight changes and medication/behavior conditions
Conditions for verification: Link period-specific co-exposure, weight changes and medication/behavior conditions to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Do not newly establish a weight-independent effect or causal effect of an individual ingredient.
Why this condition is needed: Preparation condition retaining the actual scope of period-specific co-exposure, weight changes and medication/behavior conditions.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design

N11 · How was MRI liver fat actually measured?

Required materials and conditions: MRI hepatic fat fraction, change from baseline and equipment/methods
Conditions for verification: Link mRI hepatic fat fraction, change from baseline and equipment/methods to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Prepare only the preserved-summary scope without adding definitions, values or denominators absent from original materials.
Why this condition is needed: Preparation condition retaining the actual scope of mRI hepatic fat fraction, change from baseline and equipment/methods.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application

N12 · Are five regions of interest distinguished from participant counts?

Required materials and conditions: Mean MRI regions of interest per participant and analysis unit
Conditions for verification: Link mean MRI regions of interest per participant and analysis unit to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Do not count five regions as five times the participants, independent observations or new trials.
Why this condition is needed: Preparation condition retaining the actual scope of mean MRI regions of interest per participant and analysis unit.
Referenced methods: M08 Table 8.2.a, M03 §3.2.4; Chamgap application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own design

N13 · Are relative change from baseline and final HFF distinguished?

Required materials and conditions: Period-specific baseline, change, relative/absolute measures and final values
Conditions for verification: Link period-specific baseline, change, relative/absolute measures and final values to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Do not turn relative-change proportions into final hepatic fat fraction or percentage-point absolute decreases.
Why this condition is needed: Preparation condition retaining the actual scope of period-specific baseline, change, relative/absolute measures and final values.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 §8.2.2, M15 §15.3.1; our own application

N14 · What were the original relative changes by period?

Required materials and conditions: Attribution of -7.43% to camu-camu and +8.42% to placebo
Conditions for verification: Link attribution of -7.43% to camu-camu and +8.42% to placebo to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Do not turn placebo increases or extract decreases into guaranteed individual effects or changes in everyone.
Why this condition is needed: Preparation condition retaining the actual scope of attribution of -7.43% to camu-camu and +8.42% to placebo.
Referenced methods: M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M04 §4.6.3 and M15 §§15.3.1–15.3.3; status separation is Chamgap-designed

N15 · Which contrast does the original -15.85% relative difference represent?

Required materials and conditions: Between-treatment contrast in relative change from baseline and P value
Conditions for verification: Link between-treatment contrast in relative change from baseline and P value to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Do not recalculate from -7.43 and +8.42 or newly define -15.85 as an absolute percentage-point or adjusted effect.
Why this condition is needed: Preparation condition retaining the actual scope of between-treatment contrast in relative change from baseline and P value.
Referenced methods: M08 §8.2.2, M15 §15.3.1; CHAMGAP adaptation; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP

N16 · How is the approximately 1.6-percentage-point median absolute HFF decrease retained?

Required materials and conditions: Absolute-change median, population/contrast and separate relative-measure labeling
Conditions for verification: Link absolute-change median, population/contrast and separate relative-measure labeling to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Do not assert that approximately 1.6 percentage points is a new adjusted between-treatment mean difference or conversion of -15.85%.
Why this condition is needed: Preparation condition retaining the actual scope of absolute-change median, population/contrast and separate relative-measure labeling.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations by question are our own design; M15 §15.3.1–15.3.3; our own application

N17 · What is the scope of the account that the effect CI was unreported?

Required materials and conditions: Original unreported-CI record and actual external reading scope
Conditions for verification: Link original unreported-CI record and actual external reading scope to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Do not newly calculate CI, variance or effect size from P values or sample size.
Why this condition is needed: Preparation condition retaining the actual scope of original unreported-CI record and actual external reading scope.
Referenced methods: M15 §15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design

N18 · What was the clinically important HFF threshold?

Required materials and conditions: Prespecified importance criterion, measure and uncertainty
Conditions for verification: Link prespecified importance criterion, measure and uncertainty to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Do not newly establish clinically sufficient reduction from a positive P value or 1.6 percentage points.
Why this condition is needed: Preparation condition retaining the actual scope of prespecified importance criterion, measure and uncertainty.
Referenced methods: M15 §§15.3.1–15.3.3; Chamgap adaptation

N19 · Which denominators are 35 allocated and 30 completing both periods?

Required materials and conditions: Allocation, sequence, period completion and completer analysis
Conditions for verification: Link allocation, sequence, period completion and completer analysis to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Do not copy the 30 completers as the actual MRI analysis denominator for every result.
Why this condition is needed: Preparation condition retaining the actual scope of allocation, sequence, period completion and completer analysis.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design

N20 · How do the MRI analysis counts of 20 and 25 differ?

Required materials and conditions: Actual endpoint denominators of 20 in the camu-camu period and 25 in the placebo period
Conditions for verification: Link actual endpoint denominators of 20 in the camu-camu period and 25 in the placebo period to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Do not calculate 20+25 as total participants or interpret them as two independent groups.
Why this condition is needed: Preparation condition retaining the actual scope of actual endpoint denominators of 20 in the camu-camu period and 25 in the placebo period.
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

N21 · How were completion, MRI selection and missingness handled?

Required materials and conditions: Completer analysis, missing MRI, missingness reasons/handling and sensitivity
Conditions for verification: Link completer analysis, missing MRI, missingness reasons/handling and sensitivity to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Do not calculate or invent unmeasured counts, withdrawal/analysis-exclusion rates or new ITT results.
Why this condition is needed: Preparation condition retaining the actual scope of completer analysis, missing MRI, missingness reasons/handling and sensitivity.
Referenced methods: M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.

N22 · How were sequence, period and carryover effects handled?

Required materials and conditions: Crossover model, washout, sequence/period/carryover effects and correlation
Conditions for verification: Link crossover model, washout, sequence/period/carryover effects and correlation to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Washout alone does not establish no carryover, independent periods or a complete paired analysis.
Why this condition is needed: Preparation condition retaining the actual scope of crossover model, washout, sequence/period/carryover effects and correlation.
Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M08 §8.1–8.2.3; internal application

N23 · What was the hierarchy of the prespecified MRI endpoint and other outcomes?

Required materials and conditions: Hepatic-steatosis planning, primary MRI and other markers
Conditions for verification: Link hepatic-steatosis planning, primary MRI and other markers to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Do not use liver injury markers in the paper title to create the same numerical effect as MRI or additional clinical efficacy.
Why this condition is needed: Preparation condition retaining the actual scope of hepatic-steatosis planning, primary MRI and other markers.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design

N24 · What is the status of NCT04130321 and the current original registration?

Required materials and conditions: Original registration identity, planning/change history and actual reading
Conditions for verification: Link original registration identity, planning/change history and actual reading to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: A number’s presence does not establish registration reading, prespecification certification or a completed link check.
Why this condition is needed: Preparation condition retaining the actual scope of original registration identity, planning/change history and actual reading.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.6.1–4.6.2 distinguish studies from reports; cohort/outcome linkage is internally applied

N25 · What are the report identity and actual preserved-summary locations?

Required materials and conditions: Marette 2024, Cell Reports Medicine, PMID and original evidence/citation records
Conditions for verification: Link marette 2024, Cell Reports Medicine, PMID and original evidence/citation records to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Do not infer or generate DOI/PMCID from the PMID or article number.
Why this condition is needed: Preparation condition retaining the actual scope of marette 2024, Cell Reports Medicine, PMID and original evidence/citation records.
Referenced methods: M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations

N26 · Are the same trial, periods and regions kept separate from new independent replication?

Required materials and conditions: Same crossover population, two periods, regions of interest and report family
Conditions for verification: Link same crossover population, two periods, regions of interest and report family to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Do not sum 35, 30, 20, 25, five regions or parent/subclaim sheets into new participant or independent-trial totals.
Why this condition is needed: Preparation condition retaining the actual scope of same crossover population, two periods, regions of interest and report family.
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

N27 · Are MRI reduction and actual liver-disease outcomes distinguished?

Required materials and conditions: Imaging surrogate versus cirrhosis, hospitalization, death and other clinical events
Conditions for verification: Link imaging surrogate versus cirrhosis, hospitalization, death and other clinical events to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Do not extend positive 12-week MRI results to liver-disease treatment, complication/death prevention or long-term efficacy.
Why this condition is needed: Preparation condition retaining the actual scope of imaging surrogate versus cirrhosis, hospitalization, death and other clinical events.
Referenced methods: M03 §3.2.4; internally defined extension boundary; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed

N28 · What are the product, duration and ingredient boundaries?

Required materials and conditions: Tested extract, 1.5 g/day, 12 weeks and other polyphenols
Conditions for verification: Link tested extract, 1.5 g/day, 12 weeks and other polyphenols to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Preserve the historical mention of verdict 2962 for a different plant extract without opening its materials/page or treating it as the same trial.
Why this condition is needed: Preparation condition retaining the actual scope of tested extract, 1.5 g/day, 12 weeks and other polyphenols.
Referenced methods: M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed; M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed

N29 · What is the scope of opposing, conflicting and individual-difference materials?

Required materials and conditions: Positive result, uncertainty and differences between ingredients/subgroups
Conditions for verification: Link positive result, uncertainty and differences between ingredients/subgroups to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: No search does not mean no other studies; results for other ingredients do not become direct refutation of this trial.
Why this condition is needed: Preparation condition retaining the actual scope of positive result, uncertainty and differences between ingredients/subgroups.
Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed

N30 · Which original records describe support and industry relationships?

Required materials and conditions: Nonprofit/public support, manufacturer-reporting status and research-chair disclosures
Conditions for verification: Link nonprofit/public support, manufacturer-reporting status and research-chair disclosures to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Do not convert public/nonprofit funding or unreported-support records into new certification of no conflicts or no manufacturer support.
Why this condition is needed: Preparation condition retaining the actual scope of nonprofit/public support, manufacturer-reporting status and research-chair disclosures.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

N31 · How are original dates, corrections, empty values, Korean/English wording and history preserved?

Required materials and conditions: 2026-08-26, empty correction/deliberation records and original verdict/axes
Conditions for verification: Link 2026-08-26, empty correction/deliberation records and original verdict/axes to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Do not fill unrecorded original precision/empty values with new numbers or axes, or transfer historical cross-checks into current review.
Why this condition is needed: Preparation condition retaining the actual scope of 2026-08-26, empty correction/deliberation records and original verdict/axes.
Referenced methods: M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design

N32 · What was actually read and what are the material-slot states?

Required materials and conditions: Distinction between preserved summary and external abstract, full text, registration and plans
Conditions for verification: Link distinction between preserved summary and external abstract, full text, registration and plans to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: URLs, citations or preserved copies do not establish external reading, successful access or a completed link check.
Why this condition is needed: Preparation condition retaining the actual scope of distinction between preserved summary and external abstract, full text, registration and plans.
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

N33 · What should be linked when new evidence or corrections arrive?

Required materials and conditions: Separation of conditions, original materials, observations, reading and change events
Conditions for verification: Link separation of conditions, original materials, observations, reading and change events to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Required
Application exceptions: Original candidate review-pending/production-eligibility markers are history; they do not revive an active review wait or approval process.
Why this condition is needed: Preparation condition retaining the actual scope of separation of conditions, original materials, observations, reading and change events.
Referenced methods: M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design

H01 · How were gastrointestinal discomfort and adverse events defined and collected?

Required materials and conditions: Mild gastrointestinal discomfort, relatedness and adverse-event collection/grading
Conditions for verification: Link mild gastrointestinal discomfort, relatedness and adverse-event collection/grading to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Supporting harm information
Application exceptions: Prepare only the preserved-summary scope without adding definitions, values or denominators absent from original materials.
Why this condition is needed: Preparation condition retaining the actual scope of mild gastrointestinal discomfort, relatedness and adverse-event collection/grading.
Referenced methods: M19 §§19.1.2–19.2.4; detailed distinctions are Chamgap-designed; M19 §§19.1.2–19.2.4; Chamgap adaptation

H02 · What were actual event timing and exposure?

Required materials and conditions: Intervention period, washout/switching and onset/discontinuation timing
Conditions for verification: Link intervention period, washout/switching and onset/discontinuation timing to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Supporting harm information
Application exceptions: Without original timing, do not convert the record into a confirmed camu-camu-period event rate or long-term harm.
Why this condition is needed: Preparation condition retaining the actual scope of intervention period, washout/switching and onset/discontinuation timing.
Referenced methods: M19 §19.2 design-specific harm questions; timing details are Chamgap-designed

H03 · Are harms compared by camu-camu/placebo period?

Required materials and conditions: Period-specific events, relatedness, severity and control comparison
Conditions for verification: Link period-specific events, relatedness, severity and control comparison to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Supporting harm information
Application exceptions: Historical absence of arm-specific counts does not establish zero events or safety equivalence.
Why this condition is needed: Preparation condition retaining the actual scope of period-specific events, relatedness, severity and control comparison.
Referenced methods: M19 §§19.2.2–19.2.4 and M03 §3.2.3; Chamgap adaptation

H04 · How do withdrawal and harms denominators differ?

Required materials and conditions: Original five withdrawals, one gastrointestinal-discomfort withdrawal and actual safety population
Conditions for verification: Link original five withdrawals, one gastrointestinal-discomfort withdrawal and actual safety population to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Supporting harm information
Application exceptions: Do not use new calculations such as 35-30 or 1/5 to create withdrawal reasons or adverse-effect rates.
Why this condition is needed: Preparation condition retaining the actual scope of original five withdrawals, one gastrointestinal-discomfort withdrawal and actual safety population.
Referenced methods: M19 §§19.1.2–19.2.4; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed

H05 · What level of signal does possible capsule relatedness represent?

Required materials and conditions: Discomfort timing, alternative factors and possible-relatedness judgment
Conditions for verification: Link discomfort timing, alternative factors and possible-relatedness judgment to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Supporting harm information
Application exceptions: One case does not establish confirmed camu-camu toxicity, a general incidence rate or absence of harm.
Why this condition is needed: Preparation condition retaining the actual scope of discomfort timing, alternative factors and possible-relatedness judgment.
Referenced methods: M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed; Chamgap’s own interpretation boundaries. M19 principles are referenced; no official causality tool was executed

H06 · Are unread, unreported, uncollected and actual zero outcomes distinguished?

Required materials and conditions: Unread external scope and gaps in harms results
Conditions for verification: Link unread external scope and gaps in harms results to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Supporting harm information
Application exceptions: Unread external materials do not mean zero adverse effects, no paper or failed access.
Why this condition is needed: Preparation condition retaining the actual scope of unread external scope and gaps in harms results.
Referenced methods: M19 §§19.1.2–19.2.4 and M04 §4.6.3; Chamgap adaptation

H07 · Are crossover harms and reports protected from duplicate summing?

Required materials and conditions: Harms linkage in the same participants across two periods and one report
Conditions for verification: Link harms linkage in the same participants across two periods and one report to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Supporting harm information
Application exceptions: Do not sum the two periods or allocation/completion/measurement counts as harms participants or independent trials.
Why this condition is needed: Preparation condition retaining the actual scope of harms linkage in the same participants across two periods and one report.
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

H08 · What gaps remain in long-term safety and other risk populations?

Required materials and conditions: 12-week research exposure and safety for longer periods, other formulations/populations/diseases
Conditions for verification: Link 12-week research exposure and safety for longer periods, other formulations/populations/diseases to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Supporting harm information
Application exceptions: Do not extend positive 12-week imaging results into long-term safety guarantees or safety of other polyphenols.
Why this condition is needed: Preparation condition retaining the actual scope of 12-week research exposure and safety for longer periods, other formulations/populations/diseases.
Referenced methods: M19 §§19.1.2–19.2.4; Chamgap adaptation

H09 · Are limitations of imaging benefits and harms signals retained together?

Required materials and conditions: Separation of positive MRI, uncertainty, gastrointestinal discomfort and systematic-harms gaps
Conditions for verification: Link separation of positive MRI, uncertainty, gastrointestinal discomfort and systematic-harms gaps to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Requirement and applicability: Supporting harm information
Application exceptions: Do not turn positive imaging results into liver-treatment recommendations, usage/product-selection or treatment-replacement guidance, or a definitive harms verdict.
Why this condition is needed: Preparation condition retaining the actual scope of separation of positive MRI, uncertainty, gastrointestinal discomfort and systematic-harms gaps.
Referenced methods: Chamgap interpretive boundary informed by M19 principles; no formal causality tool was run

Referenced methods and the sections actually reviewed

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

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

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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

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

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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

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

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again 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

2026-10-13 · Public page/material version 1.0

Public pages and materials were created from the existing 42 items. No new clinical search, verification-status change, or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

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

View all item details

N01 · What is the selected subclaim and its original record?

Current findings: The selected existing subclaim is reduced MRI liver fat at 12 weeks; its original verdict record is distinguished from the question. The parent question concerns reduced 12-week liver fat in overweight adults with elevated triglycerides.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Independent-claim status was not certified. The single existing subclaim is not newly split and no hypothetical main claim is created.
Reason for missing information: Independent-claim status was not certified. The single existing subclaim is not newly split and no hypothetical main claim is created.
Required materials and conditions: Original Korean/English wording and the question/record relationship for reduced 12-week MRI liver fat
Materials to obtain first: Preserved copies of the selected subclaim and complete parent summary
Further research: If the question boundary changes, retain the original wording separately from the change event.
Remaining uncertainty: Within the preserved-summary preparation scope. Independent-claim status was not certified. The single existing subclaim is not newly split and no hypothetical main claim is created.
Conditions for verification: Link original Korean/English wording and the question/record relationship for reduced 12-week MRI liver fat to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of original Korean/English wording and the question/record relationship for reduced 12-week MRI liver fat.
Application exceptions: Do not turn parent/subclaim overlap into new independent trials or additional structural units.
Referenced methods: Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design

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N02 · How are the subclaim C and parent C54, axes and history distinguished?

Current findings: Subclaim C and the note that the relative difference was -15.85%, P=0.003, but the endpoint was an imaging surrogate are retained. Subclaim score/status/axes keys are absent. Parent C54/Caution and B/S/R1/I2/E+/B2, with precision not recorded, are parent context.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Subclaim score, status and axes remain unrecorded. Parent scores or historical cross-checks are not assigned as current subclaim review or verdict values.
Reason for missing information: Subclaim score, status and axes remain unrecorded. Parent scores or historical cross-checks are not assigned as current subclaim review or verdict values.
Required materials and conditions: Subclaim grade/note, absence of score/status/axes and preservation of parent values
Materials to obtain first: Subclaim record, parent grade/score/axes and Korean/English verdict history
Further research: When a separate evidence-update event occurs, distinguish preservation of original values from the new decision.
Remaining uncertainty: Within the preserved-summary preparation scope. Subclaim score, status and axes remain unrecorded. Parent scores or historical cross-checks are not assigned as current subclaim review or verdict values.
Conditions for verification: Link subclaim grade/note, absence of score/status/axes and preservation of parent values to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of subclaim grade/note, absence of score/status/axes and preservation of parent values.
Application exceptions: C54, B2 and historical cross-checks are preserved history, not new score calculation, RoB execution or completed content review.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

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N03 · Which selected adult population was actually studied?

Current findings: The original study was a camu-camu/placebo sequence crossover trial in 35 overweight adults with elevated fasting triglycerides.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Numeric BMI/triglyceride thresholds, age/sex, liver-disease diagnosis, baseline HFF, metabolic conditions and detailed inclusion/exclusion criteria are absent from the summary.
Reason for missing information: Numeric BMI/triglyceride thresholds, age/sex, liver-disease diagnosis, baseline HFF, metabolic conditions and detailed inclusion/exclusion criteria are absent from the summary.
Required materials and conditions: Eligibility and baseline liver fat in overweight adults with elevated fasting triglycerides
Materials to obtain first: Original eligibility, baseline characteristics/liver fat and diagnostic definitions
Further research: Distinguish applicability to other populations using direct eligibility and baseline-characteristic materials.
Remaining uncertainty: Within the preserved-summary preparation scope. Numeric BMI/triglyceride thresholds, age/sex, liver-disease diagnosis, baseline HFF, metabolic conditions and detailed inclusion/exclusion criteria are absent from the summary.
Conditions for verification: Link eligibility and baseline liver fat in overweight adults with elevated fasting triglycerides to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of eligibility and baseline liver fat in overweight adults with elevated fasting triglycerides.
Application exceptions: Fatty-liver/MASLD tag names alone do not establish every participant’s diagnosis or severity.
Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap's own design

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N04 · What was the tested extract?

Current findings: Camu-camu is Myrciaria dubia fruit extract. The original safety account records gastrointestinal discomfort possibly related to capsules.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Extract standardization, raw-material equivalents, vitamin C/polyphenol quantification, manufacturer/batches, capsule count and composition are unverified.
Reason for missing information: Extract standardization, raw-material equivalents, vitamin C/polyphenol quantification, manufacturer/batches, capsule count and composition are unverified.
Required materials and conditions: Actual formulation, quantification and manufacture of Myrciaria dubia fruit extract
Materials to obtain first: Test-product composition, standardization, batches and manufacturing/supply records
Further research: Distinguish other camu-camu products when actual composition/formulation and direct materials are available.
Remaining uncertainty: Within the preserved-summary preparation scope. Extract standardization, raw-material equivalents, vitamin C/polyphenol quantification, manufacturer/batches, capsule count and composition are unverified.
Conditions for verification: Link actual formulation, quantification and manufacture of Myrciaria dubia fruit extract to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of actual formulation, quantification and manufacture of Myrciaria dubia fruit extract.
Application exceptions: Do not convert 1.5 g of extract into 1.5 g of vitamin C, fruit raw-material quantity or equivalents of other products.
Referenced methods: M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design

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N05 · What were the research exposure and actual implementation?

Current findings: The original trial used camu-camu fruit extract at 1.5 g/day for 12 weeks. This preserves the research exposure.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Individual intake/adherence, discontinuation/dose reduction, capsule composition and direct comparisons with other doses are unverified.
Reason for missing information: Individual intake/adherence, discontinuation/dose reduction, capsule composition and direct comparisons with other doses are unverified.
Required materials and conditions: Research exposure of 1.5 g/day for each 12-week period and actual adherence
Materials to obtain first: Exposure/adherence/discontinuation records and test-product details
Further research: Link follow-up materials while distinguishing nominal exposure from actual exposure.
Remaining uncertainty: Within the preserved-summary preparation scope. Individual intake/adherence, discontinuation/dose reduction, capsule composition and direct comparisons with other doses are unverified.
Conditions for verification: Link research exposure of 1.5 g/day for each 12-week period and actual adherence to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of research exposure of 1.5 g/day for each 12-week period and actual adherence.
Application exceptions: No intake, capsule-count, dose-conversion, product-selection or treatment-implementation guidance is written.
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

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N06 · What was in the placebo and which comparison was made?

Current findings: The original double-blind crossover trial compared camu-camu with placebo. The relative-change contrast is camu-camu versus placebo.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Placebo ingredients, calories, formulation, matching appearance/taste and actual delivery differences are absent from the summary.
Reason for missing information: Placebo ingredients, calories, formulation, matching appearance/taste and actual delivery differences are absent from the summary.
Required materials and conditions: Placebo composition/appearance, masking and treatment comparison
Materials to obtain first: Placebo composition, product comparison and actual exposure records
Further research: Do not automatically combine materials using a different control into the same contrast.
Remaining uncertainty: Within the preserved-summary preparation scope. Placebo ingredients, calories, formulation, matching appearance/taste and actual delivery differences are absent from the summary.
Conditions for verification: Link placebo composition/appearance, masking and treatment comparison to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of placebo composition/appearance, masking and treatment comparison.
Application exceptions: Prepare only the preserved-summary scope without adding definitions, values or denominators absent from original materials.
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

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N07 · How are intervention periods and washout distinguished?

Current findings: The original account describes each 12-week exposure followed by crossover after washout. The selected result concerns 12-week MRI liver fat.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Washout length, total actual participation duration, visit windows and measurement timing between interventions are unverified.
Reason for missing information: Washout length, total actual participation duration, visit windows and measurement timing between interventions are unverified.
Required materials and conditions: Each 12-week period, crossover after washout and actual schedule
Materials to obtain first: Original visit schedule, washout, crossover timing and actual implementation
Further research: When timing materials become available, link baseline/end measurements separately for each period.
Remaining uncertainty: Within the preserved-summary preparation scope. Washout length, total actual participation duration, visit windows and measurement timing between interventions are unverified.
Conditions for verification: Link each 12-week period, crossover after washout and actual schedule to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of each 12-week period, crossover after washout and actual schedule.
Application exceptions: Do not add the two 12-week periods into a new total duration or claim that everyone completed identical total exposure.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP; Design-specific harm questions in M19 §19.2; Detailed temporal relationships are internally designed

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N08 · What were crossover allocation and comparison units?

Current findings: The double-blind crossover trial randomized 35 participants to camu-camu/placebo sequence. Thirty completed both periods.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Sequence-specific allocation counts, allocation generation/concealment and actual intervention switching are unverified.
Reason for missing information: Sequence-specific allocation counts, allocation generation/concealment and actual intervention switching are unverified.
Required materials and conditions: Randomized intervention sequence and repeated comparison in the same participants
Materials to obtain first: Sequence allocation, concealment methods and crossover flow diagram
Further research: Retain distinctions between sequence, period and the same participants in new reports.
Remaining uncertainty: Within the preserved-summary preparation scope. Sequence-specific allocation counts, allocation generation/concealment and actual intervention switching are unverified.
Conditions for verification: Link randomized intervention sequence and repeated comparison in the same participants to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of randomized intervention sequence and repeated comparison in the same participants.
Application exceptions: Do not count camu-camu and placebo periods as independent parallel groups or two trials.
Referenced methods: M08 §8.1–8.2.3; CHAMGAP adaptation; Distinction between studies and reports in M04 §4.6.1–4.6.2; Cohort/outcome connections are CHAMGAP adaptations

Related sources R01

N09 · Are the actual roles and maintenance of double blinding known?

Current findings: The original design was recorded as double-blind.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Who was blinded, product distinguishability, MRI reader/analyst masking and unmasking timing are unverified because external materials remain unread.
Reason for missing information: Who was blinded, product distinguishability, MRI reader/analyst masking and unmasking timing are unverified because external materials remain unread.
Required materials and conditions: Masking/unmasking of participants, assessors and analysts
Materials to obtain first: Methods, masking/unmasking records and reading procedures
Further research: Distinguish the double-blind label from actual roles and procedures in additional materials.
Remaining uncertainty: Within the preserved-summary preparation scope. Who was blinded, product distinguishability, MRI reader/analyst masking and unmasking timing are unverified because external materials remain unread.
Conditions for verification: Link masking/unmasking of participants, assessors and analysts to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of masking/unmasking of participants, assessors and analysts.
Application exceptions: Prepare only the preserved-summary scope without adding definitions, values or denominators absent from original materials.
Referenced methods: M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application

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N10 · What accompanying diet, weight and medication changes occurred?

Current findings: The preserved summary describes only camu-camu/placebo sequence comparison and liver-fat change.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct definitions, values and materials are unverified within the current preserved-summary/unread-external scope. Diet, alcohol, exercise, medication, weight change, common management and period-specific differences are unverified.
Reason for missing information: Diet, alcohol, exercise, medication, weight change, common management and period-specific differences are unverified.
Required materials and conditions: Period-specific co-exposure, weight changes and medication/behavior conditions
Materials to obtain first: Period-specific co-exposure, weight, diet and medication records
Further research: Retain actual measurement/adjustment of accompanying changes together with extract exposure in follow-up research.
Remaining uncertainty: Within the preserved-summary preparation scope. Diet, alcohol, exercise, medication, weight change, common management and period-specific differences are unverified.
Conditions for verification: Link period-specific co-exposure, weight changes and medication/behavior conditions to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of period-specific co-exposure, weight changes and medication/behavior conditions.
Application exceptions: Do not newly establish a weight-independent effect or causal effect of an individual ingredient.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design

Related sources R01

N11 · How was MRI liver fat actually measured?

Current findings: The original evidence-list endpoint was change from baseline in MRI hepatic fat fraction. Results were recorded as imaging HFF.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. MRI technique/equipment, reading, reproducibility, detailed fat-fraction definition and unit handling are unverified.
Reason for missing information: MRI technique/equipment, reading, reproducibility, detailed fat-fraction definition and unit handling are unverified.
Required materials and conditions: MRI hepatic fat fraction, change from baseline and equipment/methods
Materials to obtain first: MRI measurement/reading methods and endpoint definitions
Further research: When methods are supplied, link actual technique, units and reading scope to the result.
Remaining uncertainty: Within the preserved-summary preparation scope. MRI technique/equipment, reading, reproducibility, detailed fat-fraction definition and unit handling are unverified.
Conditions for verification: Link mRI hepatic fat fraction, change from baseline and equipment/methods to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of mRI hepatic fat fraction, change from baseline and equipment/methods.
Application exceptions: Prepare only the preserved-summary scope without adding definitions, values or denominators absent from original materials.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application

Related sources R01

N12 · Are five regions of interest distinguished from participant counts?

Current findings: The original research account states that mean HFF from five MRI regions per participant was used for the prespecified hepatic-steatosis analysis.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Region locations/selection, missing regions, averaging and valid measurement criteria per participant are unverified.
Reason for missing information: Region locations/selection, missing regions, averaging and valid measurement criteria per participant are unverified.
Required materials and conditions: Mean MRI regions of interest per participant and analysis unit
Materials to obtain first: Region selection, participant-level HFF aggregation and valid measurement criteria
Further research: Distinguish regions, averages and participant-level analysis units in new measurement reports.
Remaining uncertainty: Within the preserved-summary preparation scope. Region locations/selection, missing regions, averaging and valid measurement criteria per participant are unverified.
Conditions for verification: Link mean MRI regions of interest per participant and analysis unit to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of mean MRI regions of interest per participant and analysis unit.
Application exceptions: Do not count five regions as five times the participants, independent observations or new trials.
Referenced methods: M08 Table 8.2.a, M03 §3.2.4; Chamgap application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own design

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N13 · Are relative change from baseline and final HFF distinguished?

Current findings: The endpoint was change from baseline in MRI HFF; the original reader answer describes relative change.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Period-specific baseline HFF, final absolute HFF, change dispersion and the original definition of relative-change calculation are absent from the summary.
Reason for missing information: Period-specific baseline HFF, final absolute HFF, change dispersion and the original definition of relative-change calculation are absent from the summary.
Required materials and conditions: Period-specific baseline, change, relative/absolute measures and final values
Materials to obtain first: Period-specific baseline/end/change values and original analysis definitions
Further research: Link baseline, final values, absolute change and relative change separately when result tables are added.
Remaining uncertainty: Within the preserved-summary preparation scope. Period-specific baseline HFF, final absolute HFF, change dispersion and the original definition of relative-change calculation are absent from the summary.
Conditions for verification: Link period-specific baseline, change, relative/absolute measures and final values to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of period-specific baseline, change, relative/absolute measures and final values.
Application exceptions: Do not turn relative-change proportions into final hepatic fat fraction or percentage-point absolute decreases.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 §8.2.2, M15 §15.3.1; our own application

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N14 · What were the original relative changes by period?

Current findings: Preserved relative MRI liver-fat changes were -7.43% with camu-camu versus +8.42% with placebo.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Dispersion/intervals for each relative change, period baselines and links to actual analysis participants are unverified.
Reason for missing information: Dispersion/intervals for each relative change, period baselines and links to actual analysis participants are unverified.
Required materials and conditions: Attribution of -7.43% to camu-camu and +8.42% to placebo
Materials to obtain first: Period-specific relative changes, denominators, dispersion and baselines
Further research: When original results are supplemented, link each period/measure and preserve current original values.
Remaining uncertainty: Within the preserved-summary preparation scope. Dispersion/intervals for each relative change, period baselines and links to actual analysis participants are unverified.
Conditions for verification: Link attribution of -7.43% to camu-camu and +8.42% to placebo to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of attribution of -7.43% to camu-camu and +8.42% to placebo.
Application exceptions: Do not turn placebo increases or extract decreases into guaranteed individual effects or changes in everyone.
Referenced methods: M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M04 §4.6.3 and M15 §§15.3.1–15.3.3; status separation is Chamgap-designed

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N15 · Which contrast does the original -15.85% relative difference represent?

Current findings: The original between-treatment relative difference was -15.85%, P=0.003. The summary explicitly describes a relative-change contrast, not a 15.85-percentage-point absolute reduction.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Exact paired estimand, model, adjustment, sequence/period handling and effect interval are unverified.
Reason for missing information: Exact paired estimand, model, adjustment, sequence/period handling and effect interval are unverified.
Required materials and conditions: Between-treatment contrast in relative change from baseline and P value
Materials to obtain first: Treatment-contrast model, original result tables and estimand definition
Further research: When analysis materials arrive, link the relative-change contrast and original adjustment to that analysis.
Remaining uncertainty: Within the preserved-summary preparation scope. Exact paired estimand, model, adjustment, sequence/period handling and effect interval are unverified.
Conditions for verification: Link between-treatment contrast in relative change from baseline and P value to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of between-treatment contrast in relative change from baseline and P value.
Application exceptions: Do not recalculate from -7.43 and +8.42 or newly define -15.85 as an absolute percentage-point or adjusted effect.
Referenced methods: M08 §8.2.2, M15 §15.3.1; CHAMGAP adaptation; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP

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N16 · How is the approximately 1.6-percentage-point median absolute HFF decrease retained?

Current findings: The preserved median absolute HFF decrease was approximately 1.6 percentage points. The original summary states that it should be presented alongside the relative difference.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. The exact population, period, contrast definition, interval, dispersion and baseline for this median are unverified.
Reason for missing information: The exact population, period, contrast definition, interval, dispersion and baseline for this median are unverified.
Required materials and conditions: Absolute-change median, population/contrast and separate relative-measure labeling
Materials to obtain first: Absolute HFF change tables, median population/contrast definitions and dispersion
Further research: When materials are added, link the original median to its actual population, measure and interval.
Remaining uncertainty: Within the preserved-summary preparation scope. The exact population, period, contrast definition, interval, dispersion and baseline for this median are unverified.
Conditions for verification: Link absolute-change median, population/contrast and separate relative-measure labeling to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of absolute-change median, population/contrast and separate relative-measure labeling.
Application exceptions: Do not assert that approximately 1.6 percentage points is a new adjusted between-treatment mean difference or conversion of -15.85%.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations by question are our own design; M15 §15.3.1–15.3.3; our own application

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N17 · What is the scope of the account that the effect CI was unreported?

Current findings: The original result, reader answer and synthesis recorded that the treatment-effect CI was unreported. This historical account is retained.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. External result tables, supplements and interval reporting were not read here. Nonreporting across all current materials was not newly verified.
Reason for missing information: External result tables, supplements and interval reporting were not read here. Nonreporting across all current materials was not newly verified.
Required materials and conditions: Original unreported-CI record and actual external reading scope
Materials to obtain first: Original full text, supplementary tables, estimation intervals and denominators
Further research: Link supplied intervals with their actual original location, measure and analysis while preserving the original record.
Remaining uncertainty: Within the preserved-summary preparation scope. External result tables, supplements and interval reporting were not read here. Nonreporting across all current materials was not newly verified.
Conditions for verification: Link original unreported-CI record and actual external reading scope to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of original unreported-CI record and actual external reading scope.
Application exceptions: Do not newly calculate CI, variance or effect size from P values or sample size.
Referenced methods: M15 §15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design

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N18 · What was the clinically important HFF threshold?

Current findings: The original rationale states that a prespecified clinically important between-treatment HFF threshold was unreported.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Validated thresholds for that population/measure and original planning materials were not read here.
Reason for missing information: Validated thresholds for that population/measure and original planning materials were not read here.
Required materials and conditions: Prespecified importance criterion, measure and uncertainty
Materials to obtain first: Clinical-importance validation and criteria in prespecified plans
Further research: When direct criteria are supplied, distinguish prespecified/post hoc status, measure and applicable population.
Remaining uncertainty: Within the preserved-summary preparation scope. Validated thresholds for that population/measure and original planning materials were not read here.
Conditions for verification: Link prespecified importance criterion, measure and uncertainty to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of prespecified importance criterion, measure and uncertainty.
Application exceptions: Do not newly establish clinically sufficient reduction from a positive P value or 1.6 percentage points.
Referenced methods: M15 §§15.3.1–15.3.3; Chamgap adaptation

Related sources R01

N19 · Which denominators are 35 allocated and 30 completing both periods?

Current findings: The original evidence record states 35 randomized and 30 completing both periods analyzed. These numbers describe allocation and completion of both periods.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Sequence-specific completer counts, period-specific discontinuation/withdrawal and completion definitions are unverified.
Reason for missing information: Sequence-specific completer counts, period-specific discontinuation/withdrawal and completion definitions are unverified.
Required materials and conditions: Allocation, sequence, period completion and completer analysis
Materials to obtain first: Crossover flow, sequence-specific completion and discontinuation reasons
Further research: When flow is supplemented, record allocation, each-period completion and both-period completion separately.
Remaining uncertainty: Within the preserved-summary preparation scope. Sequence-specific completer counts, period-specific discontinuation/withdrawal and completion definitions are unverified.
Conditions for verification: Link allocation, sequence, period completion and completer analysis to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of allocation, sequence, period completion and completer analysis.
Application exceptions: Do not copy the 30 completers as the actual MRI analysis denominator for every result.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design

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N20 · How do the MRI analysis counts of 20 and 25 differ?

Current findings: The original research account and grade rationale specify 20 in the camu-camu period and 25 in the placebo period for primary MRI liver-fat analysis, distinct from 30 completing both periods.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Number of the same participants with MRI in both periods, sequence-specific n, valid paired data and missingness reasons are unverified.
Reason for missing information: Number of the same participants with MRI in both periods, sequence-specific n, valid paired data and missingness reasons are unverified.
Required materials and conditions: Actual endpoint denominators of 20 in the camu-camu period and 25 in the placebo period
Materials to obtain first: MRI endpoint flow, valid paired/unilateral observations and period/sequence-specific n
Further research: Link completer counts separately from actual endpoint-analysis denominators in new analysis materials.
Remaining uncertainty: Within the preserved-summary preparation scope. Number of the same participants with MRI in both periods, sequence-specific n, valid paired data and missingness reasons are unverified.
Conditions for verification: Link actual endpoint denominators of 20 in the camu-camu period and 25 in the placebo period to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of actual endpoint denominators of 20 in the camu-camu period and 25 in the placebo period.
Application exceptions: Do not calculate 20+25 as total participants or interpret them as two independent groups.
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

N21 · How were completion, MRI selection and missingness handled?

Current findings: The parent summary identifies analysis of 30 completers from 35 randomized and period-specific MRI counts of 20/25 as key limitations of the positive result.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Reasons for MRI nonmeasurement/exclusion, whole-randomized-population analysis, imputation, missingness assumptions and sensitivity analyses are unverified.
Reason for missing information: Reasons for MRI nonmeasurement/exclusion, whole-randomized-population analysis, imputation, missingness assumptions and sensitivity analyses are unverified.
Required materials and conditions: Completer analysis, missing MRI, missingness reasons/handling and sensitivity
Materials to obtain first: Missingness reasons, analysis populations, MRI selection and sensitivity results
Further research: Retain reasons/assumptions for differences between all allocated participants and actual outcome analysis in follow-up research.
Remaining uncertainty: Within the preserved-summary preparation scope. Reasons for MRI nonmeasurement/exclusion, whole-randomized-population analysis, imputation, missingness assumptions and sensitivity analyses are unverified.
Conditions for verification: Link completer analysis, missing MRI, missingness reasons/handling and sensitivity to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of completer analysis, missing MRI, missingness reasons/handling and sensitivity.
Application exceptions: Do not calculate or invent unmeasured counts, withdrawal/analysis-exclusion rates or new ITT results.
Referenced methods: M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.

Related sources R01

N22 · How were sequence, period and carryover effects handled?

Current findings: The original study crossed over after washout. Actual analysis is summarized as a treatment contrast in relative HFF change.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Carryover assessment, sequence/period effects, paired correlation, model, adjustment and assumptions are unverified.
Reason for missing information: Carryover assessment, sequence/period effects, paired correlation, model, adjustment and assumptions are unverified.
Required materials and conditions: Crossover model, washout, sequence/period/carryover effects and correlation
Materials to obtain first: Crossover statistical model, period baselines and carryover/sequence analyses
Further research: Link both periods in the same participants and report carryover/period assumptions separately in crossover analysis materials.
Remaining uncertainty: Within the preserved-summary preparation scope. Carryover assessment, sequence/period effects, paired correlation, model, adjustment and assumptions are unverified.
Conditions for verification: Link crossover model, washout, sequence/period/carryover effects and correlation to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of crossover model, washout, sequence/period/carryover effects and correlation.
Application exceptions: Washout alone does not establish no carryover, independent periods or a complete paired analysis.
Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M08 §8.1–8.2.3; internal application

Related sources R01

N23 · What was the hierarchy of the prespecified MRI endpoint and other outcomes?

Current findings: The preserved research account records prespecified hepatic-steatosis analysis using mean HFF from five regions and the primary MRI endpoint.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Original plan dates/definitions, multiplicity and hierarchy of other liver-injury/microbiome results are unverified because external materials remain unread.
Reason for missing information: Original plan dates/definitions, multiplicity and hierarchy of other liver-injury/microbiome results are unverified because external materials remain unread.
Required materials and conditions: Hepatic-steatosis planning, primary MRI and other markers
Materials to obtain first: Endpoint/timing and multiple-testing plans in protocol, SAP and registration history
Further research: When plans are supplied, distinguish actual prespecified/post hoc and primary/supporting results.
Remaining uncertainty: Within the preserved-summary preparation scope. Original plan dates/definitions, multiplicity and hierarchy of other liver-injury/microbiome results are unverified because external materials remain unread.
Conditions for verification: Link hepatic-steatosis planning, primary MRI and other markers to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of hepatic-steatosis planning, primary MRI and other markers.
Application exceptions: Do not use liver injury markers in the paper title to create the same numerical effect as MRI or additional clinical efficacy.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design

Related sources R01

N24 · What is the status of NCT04130321 and the current original registration?

Current findings: NCT04130321 appears in the original evidence registration field and research account. It is preserved as registration identity.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Registration full text/date, change history, current recruitment/result disclosure and endpoint correspondence were not newly checked. The citation has no separate registration-number key.
Reason for missing information: Registration full text/date, change history, current recruitment/result disclosure and endpoint correspondence were not newly checked. The citation has no separate registration-number key.
Required materials and conditions: Original registration identity, planning/change history and actual reading
Materials to obtain first: Original registration/history and links between actual plans and results
Further research: Distinguish the original number, historical records and current reading scope when registration materials are supplied.
Remaining uncertainty: Within the preserved-summary preparation scope. Registration full text/date, change history, current recruitment/result disclosure and endpoint correspondence were not newly checked. The citation has no separate registration-number key.
Conditions for verification: Link original registration identity, planning/change history and actual reading to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of original registration identity, planning/change history and actual reading.
Application exceptions: A number’s presence does not establish registration reading, prespecification certification or a completed link check.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.6.1–4.6.2 distinguish studies from reports; cohort/outcome linkage is internally applied

Related sources R01

N25 · What are the report identity and actual preserved-summary locations?

Current findings: R01 is the Marette A et al. camu-camu randomized crossover report, Cell Rep Med 2024;5:101682, PMID 39168095, linked to original evidence and citation records.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. DOI, PMCID and current external bibliography/full-text locations are unspecified in this summary and were not looked up here.
Reason for missing information: DOI, PMCID and current external bibliography/full-text locations are unspecified in this summary and were not looked up here.
Required materials and conditions: Marette 2024, Cell Reports Medicine, PMID and original evidence/citation records
Materials to obtain first: Original bibliography, abstract/full text and trial linkage
Further research: When bibliography is supplemented, retain original literal wording together with the change event.
Remaining uncertainty: Within the preserved-summary preparation scope. DOI, PMCID and current external bibliography/full-text locations are unspecified in this summary and were not looked up here.
Conditions for verification: Link marette 2024, Cell Reports Medicine, PMID and original evidence/citation records to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of marette 2024, Cell Reports Medicine, PMID and original evidence/citation records.
Application exceptions: Do not infer or generate DOI/PMCID from the PMID or article number.
Referenced methods: M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations

Related sources R01

N26 · Are the same trial, periods and regions kept separate from new independent replication?

Current findings: The original summary contains one evidence record, one citation and one existing subclaim. Period crossover in the same participants and averaging regions belong to the same trial result structure.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Unique trial/participant totals were not newly certified or summed during preparation. No new direct independent-replication materials were sought.
Reason for missing information: Unique trial/participant totals were not newly certified or summed during preparation. No new direct independent-replication materials were sought.
Required materials and conditions: Same crossover population, two periods, regions of interest and report family
Materials to obtain first: Report–trial–sequence–participant–period–MRI region linkage
Further research: Distinguish recruitment, registration and participant relationships when new independent materials are supplied.
Remaining uncertainty: Within the preserved-summary preparation scope. Unique trial/participant totals were not newly certified or summed during preparation. No new direct independent-replication materials were sought.
Conditions for verification: Link same crossover population, two periods, regions of interest and report family to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of same crossover population, two periods, regions of interest and report family.
Application exceptions: Do not sum 35, 30, 20, 25, five regions or parent/subclaim sheets into new participant or independent-trial totals.
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 · Are MRI reduction and actual liver-disease outcomes distinguished?

Current findings: The original crux/product facts explicitly distinguish MRI liver fat as an imaging surrogate from clinical events such as cirrhosis, hospitalization or death.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Direct long-term fibrosis, cirrhosis, hospitalization, death, symptom and quality-of-life outcomes are unverified within the preserved scope.
Reason for missing information: Direct long-term fibrosis, cirrhosis, hospitalization, death, symptom and quality-of-life outcomes are unverified within the preserved scope.
Required materials and conditions: Imaging surrogate versus cirrhosis, hospitalization, death and other clinical events
Materials to obtain first: Direct comparisons of clinical events and long-term outcomes
Further research: Link new clinical outcomes with definitions, timing and denominators separate from MRI.
Remaining uncertainty: Within the preserved-summary preparation scope. Direct long-term fibrosis, cirrhosis, hospitalization, death, symptom and quality-of-life outcomes are unverified within the preserved scope.
Conditions for verification: Link imaging surrogate versus cirrhosis, hospitalization, death and other clinical events to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of imaging surrogate versus cirrhosis, hospitalization, death and other clinical events.
Application exceptions: Do not extend positive 12-week MRI results to liver-disease treatment, complication/death prevention or long-term efficacy.
Referenced methods: M03 §3.2.4; internally defined extension boundary; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed

Related sources R01

N28 · What are the product, duration and ingredient boundaries?

Current findings: The original counterview describes differing green-tea, curcumin, resveratrol and hesperidin results and rejects generalization to polyphenol efficacy. The verdict is limited to this extract, dose, duration and MRI endpoint.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Direct comparisons of other camu-camu products, isolated ingredients, doses/durations, populations/diseases and long-term maintenance are unverified.
Reason for missing information: Direct comparisons of other camu-camu products, isolated ingredients, doses/durations, populations/diseases and long-term maintenance are unverified.
Required materials and conditions: Tested extract, 1.5 g/day, 12 weeks and other polyphenols
Materials to obtain first: Actual product, duration, population and direct-result materials
Further research: Distinguish replication of the same question from applicability to different ingredients/products in independent follow-up research.
Remaining uncertainty: Within the preserved-summary preparation scope. Direct comparisons of other camu-camu products, isolated ingredients, doses/durations, populations/diseases and long-term maintenance are unverified.
Conditions for verification: Link tested extract, 1.5 g/day, 12 weeks and other polyphenols to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of tested extract, 1.5 g/day, 12 weeks and other polyphenols.
Application exceptions: Preserve the historical mention of verdict 2962 for a different plant extract without opening its materials/page or treating it as the same trial.
Referenced methods: M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed; M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed

Related sources R01

N29 · What is the scope of opposing, conflicting and individual-difference materials?

Current findings: The summary retains a single small positive imaging result alongside completer/MRI denominator limitations. Differences between other polyphenols provide context for separate questions.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Other direct trials for the same camu-camu question, individual responses and sequence/sex/baseline-liver-fat subgroup results were not sought or checked here.
Reason for missing information: Other direct trials for the same camu-camu question, individual responses and sequence/sex/baseline-liver-fat subgroup results were not sought or checked here.
Required materials and conditions: Positive result, uncertainty and differences between ingredients/subgroups
Materials to obtain first: Independent direct results for the same question and prespecified subgroup tables
Further research: Distinguish actual conflict for the same question from differences between ingredients/measures in new materials.
Remaining uncertainty: Within the preserved-summary preparation scope. Other direct trials for the same camu-camu question, individual responses and sequence/sex/baseline-liver-fat subgroup results were not sought or checked here.
Conditions for verification: Link positive result, uncertainty and differences between ingredients/subgroups to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of positive result, uncertainty and differences between ingredients/subgroups.
Application exceptions: No search does not mean no other studies; results for other ingredients do not become direct refutation of this trial.
Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed

Related sources R01

N30 · Which original records describe support and industry relationships?

Current findings: The original record describes Weston Family Microbiome Initiative/CIHR support and unreported manufacturer funding, free product, commercial analysis, writing and publication costs. It records A. Marette’s Pfizer/CIHR joint research chair and Y. Desjardins’s NSERC–Diana Food industrial research chair disclosures.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Original contracts, supply details, current relationships and company analysis/publication roles remain unread. No separate sponsor name appears in the summary.
Reason for missing information: Original contracts, supply details, current relationships and company analysis/publication roles remain unread. No separate sponsor name appears in the summary.
Required materials and conditions: Nonprofit/public support, manufacturer-reporting status and research-chair disclosures
Materials to obtain first: Report-specific funding, support/product supply and author-conflict declarations
Further research: Distinguish direct support, external relationships and analysis/publication roles in newly disclosed materials.
Remaining uncertainty: Within the preserved-summary preparation scope. Original contracts, supply details, current relationships and company analysis/publication roles remain unread. No separate sponsor name appears in the summary.
Conditions for verification: Link nonprofit/public support, manufacturer-reporting status and research-chair disclosures to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of nonprofit/public support, manufacturer-reporting status and research-chair disclosures.
Application exceptions: Do not convert public/nonprofit funding or unreported-support records into new certification of no conflicts or no manufacturer support.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

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N31 · How are original dates, corrections, empty values, Korean/English wording and history preserved?

Current findings: The original verified date is 2026-08-26; corrections are an empty array and deliberation an empty string. Korean/English wording, synthesis, grade-decision records, axes and false flags are preserved in the complete summary.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Separate facets and primary-failed/secondary-positive keys are absent. Empty corrections do not establish a current external correction/retraction check.
Reason for missing information: Separate facets and primary-failed/secondary-positive keys are absent. Empty corrections do not establish a current external correction/retraction check.
Required materials and conditions: 2026-08-26, empty correction/deliberation records and original verdict/axes
Materials to obtain first: Complete previous summary and actual change/correction events
Further research: When materials change, record the complete earlier text, event, version and separate application distinctly.
Remaining uncertainty: Within the preserved-summary preparation scope. Separate facets and primary-failed/secondary-positive keys are absent. Empty corrections do not establish a current external correction/retraction check.
Conditions for verification: Link 2026-08-26, empty correction/deliberation records and original verdict/axes to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of 2026-08-26, empty correction/deliberation records and original verdict/axes.
Application exceptions: Do not fill unrecorded original precision/empty values with new numbers or axes, or transfer historical cross-checks into current review.
Referenced methods: M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design

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N32 · What was actually read and what are the material-slot states?

Current findings: Preparation read the complete 2966 summary and its selected existing subclaim. One report’s summary-read slot is distinguished from unread external/required-material slots.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. External abstract, full text, registration, protocol, SAP, supplementary results/harms and support declarations were not accessed or obtained.
Reason for missing information: External abstract, full text, registration, protocol, SAP, supplementary results/harms and support declarations were not accessed or obtained.
Required materials and conditions: Distinction between preserved summary and external abstract, full text, registration and plans
Materials to obtain first: Original materials or user-supplied files and actual reading records
Further research: When materials are supplied, separately record acquisition, publication, access, actual reading scope and dates.
Remaining uncertainty: Within the preserved-summary preparation scope. External abstract, full text, registration, protocol, SAP, supplementary results/harms and support declarations were not accessed or obtained.
Conditions for verification: Link distinction between preserved summary and external abstract, full text, registration and plans to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of distinction between preserved summary and external abstract, full text, registration and plans.
Application exceptions: URLs, citations or preserved copies do not establish external reading, successful access or a completed link check.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

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N33 · What should be linked when new evidence or corrections arrive?

Current findings: Preparation transfers the existing question and original verdict into the same seven-column format. Conditions were saved/frozen before writing at a separate application time.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. No new clinical search, calculation, regrading, effect/CI, independence certification or model/self content review was performed.
Reason for missing information: No new clinical search, calculation, regrading, effect/CI, independence certification or model/self content review was performed.
Required materials and conditions: Separation of conditions, original materials, observations, reading and change events
Materials to obtain first: User-supplied MRI analysis/crossover flow, plans, corrections and harms materials
Further research: Only for new materials and actual changes, distinguish complete earlier files, events, condition version/freeze, separate application and current handoff.
Remaining uncertainty: Within the preserved-summary preparation scope. No new clinical search, calculation, regrading, effect/CI, independence certification or model/self content review was performed.
Conditions for verification: Link separation of conditions, original materials, observations, reading and change events to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of separation of conditions, original materials, observations, reading and change events.
Application exceptions: Original candidate review-pending/production-eligibility markers are history; they do not revive an active review wait or approval process.
Referenced methods: M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design

Related sources R01

H01 · How were gastrointestinal discomfort and adverse events defined and collected?

Current findings: The original safety account records one participant discontinuing for mild gastrointestinal discomfort considered possibly capsule-related.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Adverse-event definitions, severity criteria, collection methods, relatedness adjudication and complete event lists are unverified.
Reason for missing information: Adverse-event definitions, severity criteria, collection methods, relatedness adjudication and complete event lists are unverified.
Required materials and conditions: Mild gastrointestinal discomfort, relatedness and adverse-event collection/grading
Materials to obtain first: Original harms definitions, collection/relatedness review and complete result tables
Further research: Retain consistent collection/grading for gastrointestinal events and other harms in follow-up research.
Remaining uncertainty: Within the preserved-summary preparation scope. Adverse-event definitions, severity criteria, collection methods, relatedness adjudication and complete event lists are unverified.
Conditions for verification: Link mild gastrointestinal discomfort, relatedness and adverse-event collection/grading to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of mild gastrointestinal discomfort, relatedness and adverse-event collection/grading.
Application exceptions: Prepare only the preserved-summary scope without adding definitions, values or denominators absent from original materials.
Referenced methods: M19 §§19.1.2–19.2.4; detailed distinctions are Chamgap-designed; M19 §§19.1.2–19.2.4; Chamgap adaptation

Related sources R01

H02 · What were actual event timing and exposure?

Current findings: The original harms record concerns possibly capsule-related gastrointestinal discomfort leading to discontinuation in the crossover trial.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Which intervention/sequence/period, onset/discontinuation timing, actual exposure and postdiscontinuation follow-up are unverified.
Reason for missing information: Which intervention/sequence/period, onset/discontinuation timing, actual exposure and postdiscontinuation follow-up are unverified.
Required materials and conditions: Intervention period, washout/switching and onset/discontinuation timing
Materials to obtain first: Event–sequence–period–exposure–discontinuation linkage and observation duration
Further research: Distinguish event periods, actual exposure at risk and postdiscontinuation course in harms reports.
Remaining uncertainty: Within the preserved-summary preparation scope. Which intervention/sequence/period, onset/discontinuation timing, actual exposure and postdiscontinuation follow-up are unverified.
Conditions for verification: Link intervention period, washout/switching and onset/discontinuation timing to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of intervention period, washout/switching and onset/discontinuation timing.
Application exceptions: Without original timing, do not convert the record into a confirmed camu-camu-period event rate or long-term harm.
Referenced methods: M19 §19.2 design-specific harm questions; timing details are Chamgap-designed

Related sources R01

H03 · Are harms compared by camu-camu/placebo period?

Current findings: The parent summary describes a safety-data gap because systematic adverse-event tables and arm-specific serious-event counts were absent.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Current external tables remain unread. Complete period-specific adverse events, serious events and intervals are unverified.
Reason for missing information: Current external tables remain unread. Complete period-specific adverse events, serious events and intervals are unverified.
Required materials and conditions: Period-specific events, relatedness, severity and control comparison
Materials to obtain first: Crossover period-specific adverse/serious events, controls and intervals
Further research: When actual harms materials are added, link period-specific exposure in the same participants to original definitions.
Remaining uncertainty: Within the preserved-summary preparation scope. Current external tables remain unread. Complete period-specific adverse events, serious events and intervals are unverified.
Conditions for verification: Link period-specific events, relatedness, severity and control comparison to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of period-specific events, relatedness, severity and control comparison.
Application exceptions: Historical absence of arm-specific counts does not establish zero events or safety equivalence.
Referenced methods: M19 §§19.2.2–19.2.4 and M03 §3.2.3; Chamgap adaptation

Related sources R01

H04 · How do withdrawal and harms denominators differ?

Current findings: The original summary states that one of five withdrawals followed mild gastrointestinal discomfort possibly capsule-related. This harms record is separate from allocation of 35, completion of 30 and MRI counts of 20/25.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Other withdrawal reasons, period-specific harms-exposure n, collection/analysis denominators and repeated event counts are unverified.
Reason for missing information: Other withdrawal reasons, period-specific harms-exposure n, collection/analysis denominators and repeated event counts are unverified.
Required materials and conditions: Original five withdrawals, one gastrointestinal-discomfort withdrawal and actual safety population
Materials to obtain first: Withdrawal reasons, period-specific exposure and safety-analysis flow
Further research: Distinguish allocation, exposure, period-specific collection and analysis denominators in harms materials.
Remaining uncertainty: Within the preserved-summary preparation scope. Other withdrawal reasons, period-specific harms-exposure n, collection/analysis denominators and repeated event counts are unverified.
Conditions for verification: Link original five withdrawals, one gastrointestinal-discomfort withdrawal and actual safety population to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of original five withdrawals, one gastrointestinal-discomfort withdrawal and actual safety population.
Application exceptions: Do not use new calculations such as 35-30 or 1/5 to create withdrawal reasons or adverse-effect rates.
Referenced methods: M19 §§19.1.2–19.2.4; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed

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H05 · What level of signal does possible capsule relatedness represent?

Current findings: The original record is a case of discontinuation for mild gastrointestinal discomfort considered possibly capsule-related.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Diagnosis, accompanying food/medication, background symptoms, rechallenge, independent relatedness review and confirmed cause are unverified.
Reason for missing information: Diagnosis, accompanying food/medication, background symptoms, rechallenge, independent relatedness review and confirmed cause are unverified.
Required materials and conditions: Discomfort timing, alternative factors and possible-relatedness judgment
Materials to obtain first: Original case course, alternative explanations and relatedness judgment
Further research: Distinguish a possible-relatedness signal from direct causal judgment in additional harms materials.
Remaining uncertainty: Within the preserved-summary preparation scope. Diagnosis, accompanying food/medication, background symptoms, rechallenge, independent relatedness review and confirmed cause are unverified.
Conditions for verification: Link discomfort timing, alternative factors and possible-relatedness judgment to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of discomfort timing, alternative factors and possible-relatedness judgment.
Application exceptions: One case does not establish confirmed camu-camu toxicity, a general incidence rate or absence of harm.
Referenced methods: M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed; Chamgap’s own interpretation boundaries. M19 principles are referenced; no official causality tool was executed

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H06 · Are unread, unreported, uncollected and actual zero outcomes distinguished?

Current findings: The original summary records absent systematic adverse-event tables and arm-specific serious-event counts. External papers/supplements were not read here.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct definitions, values and materials are unverified within the current preserved-summary/unread-external scope. Actual distinctions in current external originals between uncollected, unreported, missing and zero events are unverified.
Reason for missing information: Actual distinctions in current external originals between uncollected, unreported, missing and zero events are unverified.
Required materials and conditions: Unread external scope and gaps in harms results
Materials to obtain first: Harms collection plans, complete results, missingness reasons and supplementary tables
Further research: Link actual zero, missing, unreported and uncollected states separately only for supplied materials.
Remaining uncertainty: Within the preserved-summary preparation scope. Actual distinctions in current external originals between uncollected, unreported, missing and zero events are unverified.
Conditions for verification: Link unread external scope and gaps in harms results to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of unread external scope and gaps in harms results.
Application exceptions: Unread external materials do not mean zero adverse effects, no paper or failed access.
Referenced methods: M19 §§19.1.2–19.2.4 and M04 §4.6.3; Chamgap adaptation

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H07 · Are crossover harms and reports protected from duplicate summing?

Current findings: The crossover trial in this summary is one report in which the same participants undergo camu-camu and placebo periods.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Duplicate/repeated relationships of participants/events by sequence and period and new independent harms materials are unverified.
Reason for missing information: Duplicate/repeated relationships of participants/events by sequence and period and new independent harms materials are unverified.
Required materials and conditions: Harms linkage in the same participants across two periods and one report
Materials to obtain first: Participant–sequence–period–event–report linkage
Further research: Distinguish rereporting of the same event from new events when harms materials are supplemented.
Remaining uncertainty: Within the preserved-summary preparation scope. Duplicate/repeated relationships of participants/events by sequence and period and new independent harms materials are unverified.
Conditions for verification: Link harms linkage in the same participants across two periods and one report to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of harms linkage in the same participants across two periods and one report.
Application exceptions: Do not sum the two periods or allocation/completion/measurement counts as harms participants or independent trials.
Referenced methods: M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations

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H08 · What gaps remain in long-term safety and other risk populations?

Current findings: Parent safety is Caution. The original question concerns MRI liver-fat change with a specific extract and research exposure.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Direct harms from longer exposure, other doses/formulations, liver-disease severity, vulnerable populations and drug interactions were not checked here.
Reason for missing information: Direct harms from longer exposure, other doses/formulations, liver-disease severity, vulnerable populations and drug interactions were not checked here.
Required materials and conditions: 12-week research exposure and safety for longer periods, other formulations/populations/diseases
Materials to obtain first: Direct population/product/period-specific harms and long-term collection materials
Further research: Retain actual exposure, population, duration and collection methods in long-term safety research.
Remaining uncertainty: Within the preserved-summary preparation scope. Direct harms from longer exposure, other doses/formulations, liver-disease severity, vulnerable populations and drug interactions were not checked here.
Conditions for verification: Link 12-week research exposure and safety for longer periods, other formulations/populations/diseases to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of 12-week research exposure and safety for longer periods, other formulations/populations/diseases.
Application exceptions: Do not extend positive 12-week imaging results into long-term safety guarantees or safety of other polyphenols.
Referenced methods: M19 §§19.1.2–19.2.4; Chamgap adaptation

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H09 · Are limitations of imaging benefits and harms signals retained together?

Current findings: The selected original MRI result is grade C/positive, alongside small-crossover/completer/MRI denominator limitations, a gastrointestinal-discomfort case and harms-data gaps.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. No new benefit–harm synthesis, clinical treatment selection or usage guidance was created.
Reason for missing information: No new benefit–harm synthesis, clinical treatment selection or usage guidance was created.
Required materials and conditions: Separation of positive MRI, uncertainty, gastrointestinal discomfort and systematic-harms gaps
Materials to obtain first: Additional original direct-result, harms and follow-up materials
Further research: When new materials are supplied, link imaging, clinical and harms results and their change events separately.
Remaining uncertainty: Within the preserved-summary preparation scope. No new benefit–harm synthesis, clinical treatment selection or usage guidance was created.
Conditions for verification: Link separation of positive MRI, uncertainty, gastrointestinal discomfort and systematic-harms gaps to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.
Why this condition is needed: Preparation condition retaining the actual scope of separation of positive MRI, uncertainty, gastrointestinal discomfort and systematic-harms gaps.
Application exceptions: Do not turn positive imaging results into liver-treatment recommendations, usage/product-selection or treatment-replacement guidance, or a definitive harms verdict.
Referenced methods: Chamgap interpretive boundary informed by M19 principles; no formal causality tool was run

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