# Camu-camu fruit extract · 12-week MRI liver fat — Evidence Check Verdict 2966 · Evidence Check Stored-material review date: Not recorded Original evidence cut-off: 2026-08-26 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-13 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - Population: 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 ## Checklist items ### N01 · What is the selected subclaim and its original record? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - 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. - Referenced methods: Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design - Related sources: R01 ### N02 · How are the subclaim C and parent C54, axes and history distinguished? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - 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. - Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design - Related sources: R01 ### N03 · Which selected adult population was actually studied? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original study was a camu-camu/placebo sequence crossover trial in 35 overweight adults with elevated fasting triglycerides. - 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. - 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. - 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. - Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap's own design - Related sources: R01 ### N04 · What was the tested extract? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Camu-camu is Myrciaria dubia fruit extract. The original safety account records gastrointestinal discomfort possibly related to capsules. - 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. - 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. - 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. - Referenced methods: M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design - Related sources: R01 ### N05 · What were the research exposure and actual implementation? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original trial used camu-camu fruit extract at 1.5 g/day for 12 weeks. This preserves the research exposure. - 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. - 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. - Remaining uncertainty: Within the preserved-summary preparation scope. Individual intake/adherence, discontinuation/dose reduction, capsule composition and direct comparisons with other doses are unverified. - Referenced methods: M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed - Related sources: R01 ### N06 · What was in the placebo and which comparison was made? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original double-blind crossover trial compared camu-camu with placebo. The relative-change contrast is camu-camu versus placebo. - 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. - 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. - Remaining uncertainty: Within the preserved-summary preparation scope. Placebo ingredients, calories, formulation, matching appearance/taste and actual delivery differences are absent from the summary. - Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application - Related sources: R01 ### N07 · How are intervention periods and washout distinguished? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original account describes each 12-week exposure followed by crossover after washout. The selected result concerns 12-week MRI liver fat. - 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. - 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. - Remaining uncertainty: Within the preserved-summary preparation scope. Washout length, total actual participation duration, visit windows and measurement timing between interventions are unverified. - 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 - Related sources: R01 ### N08 · What were crossover allocation and comparison units? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The double-blind crossover trial randomized 35 participants to camu-camu/placebo sequence. Thirty completed both periods. - 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. - 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. - Remaining uncertainty: Within the preserved-summary preparation scope. Sequence-specific allocation counts, allocation generation/concealment and actual intervention switching are unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original design was recorded as double-blind. - 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. - 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. - 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. - Referenced methods: M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application - Related sources: R01 ### N10 · What accompanying diet, weight and medication changes occurred? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: The preserved summary describes only camu-camu/placebo sequence comparison and liver-fat change. - 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. - 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. - Remaining uncertainty: Within the preserved-summary preparation scope. Diet, alcohol, exercise, medication, weight change, common management and period-specific differences are unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original evidence-list endpoint was change from baseline in MRI hepatic fat fraction. Results were recorded as imaging HFF. - 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. - 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. - Remaining uncertainty: Within the preserved-summary preparation scope. MRI technique/equipment, reading, reproducibility, detailed fat-fraction definition and unit handling are unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original research account states that mean HFF from five MRI regions per participant was used for the prespecified hepatic-steatosis analysis. - 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. - 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. - Remaining uncertainty: Within the preserved-summary preparation scope. Region locations/selection, missing regions, averaging and valid measurement criteria per participant are unverified. - 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 - Related sources: R01 ### N13 · Are relative change from baseline and final HFF distinguished? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The endpoint was change from baseline in MRI HFF; the original reader answer describes relative change. - 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. - 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. - 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. - 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 - Related sources: R01 ### N14 · What were the original relative changes by period? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Preserved relative MRI liver-fat changes were -7.43% with camu-camu versus +8.42% with placebo. - 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. - 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. - Remaining uncertainty: Within the preserved-summary preparation scope. Dispersion/intervals for each relative change, period baselines and links to actual analysis participants are unverified. - 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 - Related sources: R01 ### N15 · Which contrast does the original -15.85% relative difference represent? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Within the preserved-summary preparation scope. Exact paired estimand, model, adjustment, sequence/period handling and effect interval are unverified. - 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 - Related sources: R01 ### N16 · How is the approximately 1.6-percentage-point median absolute HFF decrease retained? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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%. - Remaining uncertainty: Within the preserved-summary preparation scope. The exact population, period, contrast definition, interval, dispersion and baseline for this median are unverified. - 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 - Related sources: R01 ### N17 · What is the scope of the account that the effect CI was unreported? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original result, reader answer and synthesis recorded that the treatment-effect CI was unreported. This historical account is retained. - 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. - 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. - 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. - 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 - Related sources: R01 ### N18 · What was the clinically important HFF threshold? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original rationale states that a prespecified clinically important between-treatment HFF threshold was unreported. - 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. - 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. - Remaining uncertainty: Within the preserved-summary preparation scope. Validated thresholds for that population/measure and original planning materials were not read here. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original evidence record states 35 randomized and 30 completing both periods analyzed. These numbers describe allocation and completion of both periods. - 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. - 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. - Remaining uncertainty: Within the preserved-summary preparation scope. Sequence-specific completer counts, period-specific discontinuation/withdrawal and completion definitions are unverified. - Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design - Related sources: R01 ### N20 · How do the MRI analysis counts of 20 and 25 differ? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original study crossed over after washout. Actual analysis is summarized as a treatment contrast in relative HFF change. - 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. - 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. - Remaining uncertainty: Within the preserved-summary preparation scope. Carryover assessment, sequence/period effects, paired correlation, model, adjustment and assumptions are unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The preserved research account records prespecified hepatic-steatosis analysis using mean HFF from five regions and the primary MRI endpoint. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: NCT04130321 appears in the original evidence registration field and research account. It is preserved as registration identity. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - 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. - 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. - Related sources: R01 ### N31 · How are original dates, corrections, empty values, Korean/English wording and history preserved? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - 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. - 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 ### N32 · What was actually read and what are the material-slot states? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - 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. - Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design - Related sources: R01 ### N33 · What should be linked when new evidence or corrections arrive? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original safety account records one participant discontinuing for mild gastrointestinal discomfort considered possibly capsule-related. - 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. - 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. - Remaining uncertainty: Within the preserved-summary preparation scope. Adverse-event definitions, severity criteria, collection methods, relatedness adjudication and complete event lists are unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original harms record concerns possibly capsule-related gastrointestinal discomfort leading to discontinuation in the crossover trial. - 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. - 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. - Remaining uncertainty: Within the preserved-summary preparation scope. Which intervention/sequence/period, onset/discontinuation timing, actual exposure and postdiscontinuation follow-up are unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The parent summary describes a safety-data gap because systematic adverse-event tables and arm-specific serious-event counts were absent. - 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. - 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. - Remaining uncertainty: Within the preserved-summary preparation scope. Current external tables remain unread. Complete period-specific adverse events, serious events and intervals are unverified. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - 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. - 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 - Related sources: R01 ### H05 · What level of signal does possible capsule relatedness represent? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original record is a case of discontinuation for mild gastrointestinal discomfort considered possibly capsule-related. - 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. - 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. - Remaining uncertainty: Within the preserved-summary preparation scope. Diagnosis, accompanying food/medication, background symptoms, rechallenge, independent relatedness review and confirmed cause are unverified. - 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 - Related sources: R01 ### H06 · Are unread, unreported, uncollected and actual zero outcomes distinguished? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: The original summary records absent systematic adverse-event tables and arm-specific serious-event counts. External papers/supplements were not read here. - 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. - 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. - Remaining uncertainty: Within the preserved-summary preparation scope. Actual distinctions in current external originals between uncollected, unreported, missing and zero events are unverified. - Referenced methods: M19 §§19.1.2–19.2.4 and M04 §4.6.3; Chamgap adaptation - Related sources: R01 ### H07 · Are crossover harms and reports protected from duplicate summing? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The crossover trial in this summary is one report in which the same participants undergo camu-camu and placebo periods. - 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. - 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. - 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. - Referenced methods: M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations - Related sources: R01 ### H08 · What gaps remain in long-term safety and other risk populations? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Parent safety is Caution. The original question concerns MRI liver-fat change with a specific extract and research exposure. - 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. - 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. - 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. - Referenced methods: M19 §§19.1.2–19.2.4; Chamgap adaptation - Related sources: R01 ### H09 · Are limitations of imaging benefits and harms signals retained together? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Within the preserved-summary preparation scope. No new benefit–harm synthesis, clinical treatment selection or usage guidance was created. - Referenced methods: Chamgap interpretive boundary informed by M19 principles; no formal causality tool was run - Related sources: R01 ## Evidence and sources ### 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](https://pubmed.ncbi.nlm.nih.gov/39168095/) Materials actually read: Summary read; external materials not read Findings recorded in the 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 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. | 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. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · 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/materials 1.0. Public pages and materials were created from the existing 42 items. No new clinical search, verification-status change, or scoring was performed.