{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2984-s0", "verdict_number": "2984", "title": "Bundled green-MED diet × Eighteen-month MRS intrahepatic-fat reduction", "view_version": "1.0", "view_created_date": "2026-10-15", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-09-07", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "Adults with abdominal obesity or dyslipidemia; the original 294 randomized participants, retention and eligible-MRS proportions remain within their reported scope.", "intervention": "A green Mediterranean diet combining walnuts, green tea, Mankai and restriction of red and processed meat.", "dose": "Original research exposures: both MED groups received 28 g/day walnuts; green-MED added 3-4 cups/day green tea, 100 g/day frozen Mankai and greater red and processed meat restriction. These are preserved study conditions, not diet or intake instructions.", "comparator": "Conventional MED and healthy-diet guidance, HDG; physical activity was common to all groups and walnuts to both MED groups.", "endpoint": "18-month intrahepatic-fat change by proton MRS; distinguish original proportional reductions from the weight-adjusted green-MED versus MED P value.", "duration": "18 months", "excluded_extensions": [ "Attributing effects to Mankai, green tea or walnuts alone, or creating new isolated-component question splits", "Converting proportional reductions into absolute fat, percentage points, adjusted between-group effects or CIs", "Adding the same trial, participants, groups or time points as independent trials or participants", "Extending MRS changes into clinical liver-disease events or successful treatment replacement", "Diet, product or intake, weight or liver-disease management, or treatment-replacement instructions" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "How are the selected question and the isolated-component question distinguished?", "needed": "Selected question and verdict record, with parent and isolated-component boundaries", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are the selected question and the isolated-component question distinguished?", "application_exception": "The original isolated-component question has grade ? and a note that individual effects were not separated. These are not filled with the bundled-diet grade C.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Selected question and verdict record, with parent and isolated-component boundaries.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M03 §3.2.4; internally defined extension boundaries", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research questions distinguishing bundled diets from individual components", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The selected existing question is 18-month intrahepatic-fat reduction from the bundled green-MED pattern, linked to its subclaim record. Liver-fat reduction from Mankai or green tea alone is preserved as context; no new split or verdict is created.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. Clinical independence and isolated-component effects have not been newly certified.", "missingness": "Clinical independence and isolated-component effects have not been newly certified.", "uncertainty": "Clinical independence and isolated-component effects have not been newly certified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Records of changes to the original question, intervention, population, comparator, duration and scope" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "How are the original subclaim grade, note and absent values preserved?", "needed": "Subclaim C and note, absent score, status and axes, and parent history", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are the original subclaim grade, note and absent values preserved?", "application_exception": "Parent 46 points are not transferred into the subclaim score, and C is not inherited as a current passed content review or efficacy certification.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Subclaim C and note, absent score, status and axes, and parent history.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Records distinguishing additional evidence from preservation of the original grade", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Subclaim grade C and the note, weight-adjusted P=.035 versus conventional MED, are preserved. Subclaim score, status and axes are absent; parent C with 46 points and axes provide separate historical context.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. The selected subclaim score, status and axes are absent from the original.", "missingness": "The selected subclaim score, status and axes are absent from the original.", "uncertainty": "The selected subclaim score, status and axes are absent from the original.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original subclaim and an explicit change event" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What was the actual study population?", "needed": "Adults with abdominal obesity or dyslipidemia and enrollment scope", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What was the actual study population?", "application_exception": "MRS liver-fat changes are not extended into treatment effects for liver disease generally.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Adults with abdominal obesity or dyslipidemia and enrollment scope.", "basis": "M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Diet research with an explicit population boundary", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original research explanation records 294 adults with abdominal obesity or dyslipidemia. This is not recast as requiring both conditions together or as findings in every patient with liver disease.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. Exact eligibility and exclusion criteria, diagnoses, baseline liver disease, severity and demographic characteristics are unverified.", "missingness": "Exact eligibility and exclusion criteria, diagnoses, baseline liver disease, severity and demographic characteristics are unverified.", "uncertainty": "Exact eligibility and exclusion criteria, diagnoses, baseline liver disease, severity and demographic characteristics are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility, baseline characteristics and liver-disease diagnostic material" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "How are sex, baseline liver fat and subgroups distinguished?", "needed": "Baseline characteristics, liver-fat levels and population-specific denominators", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are sex, baseline liver fat and subgroups distinguished?", "application_exception": "Population counts or proportions possibly known from other reports are not newly added, and overall findings are not copied into subgroups.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Baseline characteristics, liver-fat levels and population-specific denominators.", "basis": "M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research with explicit population and subgroup plans", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The current summary provides abdominal obesity or dyslipidemia and the total allocation count. It does not present findings and denominators by sex, baseline liver fat or disease-defined subgroups.", "condition_status": "Unverified", "status_reason": "Required direct material has not been established within the current summary and unread external-material scope. Sex, baseline liver fat, subgroup denominators and effects, and interactions are unverified.", "missingness": "Sex, baseline liver fat, subgroup denominators and effects, and interactions are unverified.", "uncertainty": "Sex, baseline liver fat, subgroup denominators and effects, and interactions are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline and subgroup tables and prespecified analyses" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "What did the bundled green-MED exposure include?", "needed": "The original package of walnuts, green tea, Mankai and meat restriction", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What did the bundled green-MED exposure include?", "application_exception": "No new implementation guidance for menus, intake, products or dose conversions is produced.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: The original package of walnuts, green tea, Mankai and meat restriction.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research specifying the bundled pattern and exposure scope", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Green-MED combined walnuts, green tea, Mankai and greater restriction of red and processed meat. Original research exposures of 3-4 cups/day green tea and 100 g/day frozen Mankai are preserved only as study conditions.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. Ingredients, preparation and provision, whole-diet and energy targets, and actual adherence details are unverified.", "missingness": "Ingredients, preparation and provision, whole-diet and energy targets, and actual adherence details are unverified.", "uncertainty": "Ingredients, preparation and provision, whole-diet and energy targets, and actual adherence details are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Intervention specifications, provision and adherence records, and the original protocol" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "How are common physical activity and walnut exposure distinguished across groups?", "needed": "Physical activity in all groups and 28 g/day walnuts in both MED groups", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are common physical activity and walnut exposure distinguished across groups?", "application_exception": "Common-exposure quantities are original research information, not exercise or intake instructions.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Physical activity in all groups and 28 g/day walnuts in both MED groups.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research specifying common co-exposures and the dietary contrast of interest", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "All three groups undertook a physical-activity program, and both MED groups received 28 g/day walnuts. Walnuts are not presented as unique to green-MED, and findings are not read as a diet-only effect without physical activity.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. Exercise, common support, walnut adherence and actual exposure differences by group are unverified.", "missingness": "Exercise, common support, walnut adherence and actual exposure differences by group are unverified.", "uncertainty": "Exercise, common support, walnut adherence and actual exposure differences by group are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Common-program, food-provision and group adherence material" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "What were the separate green-MED, conventional MED and HDG comparisons?", "needed": "Three-group comparisons and contrast-specific effects of interest", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What were the separate green-MED, conventional MED and HDG comparisons?", "application_exception": "The adjusted green-MED versus MED P value is not copied into green-MED versus HDG or MED versus HDG.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Three-group comparisons and contrast-specific effects of interest.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are Chamgap design; M08 §8.2.2, M15 §15.3.1; Chamgap adaptation", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research distinguishing comparator-specific effects of interest in advance", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "294 participants were allocated to healthy-diet guidance (HDG), MED and green-MED. Healthy-diet guidance in the original classification fields does not erase the conventional-MED comparison; each contrast is distinguished.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. Detailed HDG and MED targets, support, composition and exact contrast-specific effects and CIs are unverified.", "missingness": "Detailed HDG and MED targets, support, composition and exact contrast-specific effects and CIs are unverified.", "uncertainty": "Detailed HDG and MED targets, support, composition and exact contrast-specific effects and CIs are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Intervention and support specifications for each group and contrast-specific analysis tables" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Were food provision and actual dietary adherence established?", "needed": "Provided exposure, intake and meat restriction, and departures", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Were food provision and actual dietary adherence established?", "application_exception": "Provision targets are not treated as every participant's actual intake or dose.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Provided exposure, intake and meat restriction, and departures.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research distinguishing exposure departures from allocation effects", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original text describes receipt of foods and additional restrictions, but the summary does not provide detailed actual intake, adherence, cross-group contamination or exposure changes.", "condition_status": "Unverified", "status_reason": "Required direct material has not been established within the current summary and unread external-material scope. Actual diets, support participation, departures, contamination and adherence denominators are unverified.", "missingness": "Actual diets, support participation, departures, contamination and adherence denominators are unverified.", "uncertainty": "Actual diets, support participation, departures, contamination and adherence denominators are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Diet and adherence records, provision history and the protocol" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "How are the 18-month endpoint and persistence after stopping distinguished?", "needed": "Intervention duration, outcome visits and additional follow-up", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are the 18-month endpoint and persistence after stopping distinguished?", "application_exception": "18 months is not recast as guaranteed persistence for everyone or a liver-disease management schedule.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Intervention duration, outcome visits and additional follow-up.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research distinguishing the intervention endpoint from persistent effects", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original trial lasted 18 months, and the selected outcome was 18-month MRS intrahepatic-fat change. Persistence, recurrence and longer-term outcomes after the intervention are not separately presented.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. Visit windows, outcomes after stopping exposure and persistence across time periods are unverified.", "missingness": "Visit windows, outcomes after stopping exposure and persistence across time periods are unverified.", "uncertainty": "Visit windows, outcomes after stopping exposure and persistence across time periods are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Visit schedules and time-specific and post-treatment material" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "What were the units and methods for proton-MRS intrahepatic fat?", "needed": "MRS liver-fat measurement, original units and calculation definitions", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What were the units and methods for proton-MRS intrahepatic fat?", "application_exception": "Proportional reductions are not recast as absolute fat content, percentage-point change or disappearance of liver fat.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: MRS liver-fat measurement, original units and calculation definitions.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; Internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Intrahepatic-fat research with specified measurement and calculation methods", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Intrahepatic fat was measured by proton MRS. Preserved figures describe proportional reduction in percent; absolute liver-fat fractions and calculation or measurement specifications are not separately provided.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. MRS equipment and location, eligibility criteria, unit definitions, reproducibility and original absolute measurements are unverified.", "missingness": "MRS equipment and location, eligibility criteria, unit definitions, reproducibility and original absolute measurements are unverified.", "uncertainty": "MRS equipment and location, eligibility criteria, unit definitions, reproducibility and original absolute measurements are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "MRS measurement and eligibility methods and original value tables" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "How are the three group-specific proportional reductions preserved?", "needed": "Original scope of green-MED -38.9%, MED -19.6% and HDG -12.2%", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are the three group-specific proportional reductions preserved?", "application_exception": "-38.9% is not attributed to Mankai alone or presented as a guaranteed personal reduction.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Original scope of green-MED -38.9%, MED -19.6% and HDG -12.2%.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Plans distinguishing within-group changes from between-group effects of interest", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Original proportional reductions are green-MED -38.9%, MED -19.6% and HDG -12.2%. These remain group-change descriptions; no new between-group differences, percentage points or effect estimates are calculated.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. Proportional-change formulas, aggregation, group variability, denominators and CIs are unverified.", "missingness": "Proportional-change formulas, aggregation, group variability, denominators and CIs are unverified.", "uncertainty": "Proportional-change formulas, aggregation, group variability, denominators and CIs are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group proportional-change definitions, result tables and denominators" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Were baseline and final absolute liver fat and absolute changes established?", "needed": "Baseline and 18-month absolute MRS values, units and changes", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Were baseline and final absolute liver fat and absolute changes established?", "application_exception": "Absolute liver-fat quantities or percentage points are not reconstructed from original proportional values.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Baseline and 18-month absolute MRS values, units and changes.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research specifying absolute and proportional effects of interest together", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original summary presents only proportional reductions. Baseline and final absolute liver fat, absolute changes, percentage points and absolute between-group effects remain unverified.", "condition_status": "Unverified", "status_reason": "Required direct material has not been established within the current summary and unread external-material scope. Absolute baseline and final values, changes, units and CIs are unverified.", "missingness": "Absolute baseline and final values, changes, units and CIs are unverified.", "uncertainty": "Absolute baseline and final values, changes, units and CIs are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original baseline and final MRS tables, definitions and denominators" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Which contrast does weight-adjusted P=.035 describe?", "needed": "Green-MED versus MED adjusted for weight loss", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Which contrast does weight-adjusted P=.035 describe?", "application_exception": "Weight adjustment does not isolate individual components or conclusively establish mechanisms beyond weight change.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Green-MED versus MED adjusted for weight loss.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research distinguishing allocation contrasts from adjusted effects of interest", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The weight-loss-adjusted green-MED versus conventional MED comparison is recorded as P=.035. This P value is not treated as the same quantity as original group proportional reductions or effects and CIs for other contrasts.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. Adjusted models, covariates, effect units and estimates, CIs and denominators are unverified.", "missingness": "Adjusted models, covariates, effect units and estimates, CIs and denominators are unverified.", "uncertainty": "Adjusted models, covariates, effect units and estimates, CIs and denominators are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Adjusted models, contrast-specific result tables and the SAP" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Are other contrasts and unadjusted or adjusted effects kept separate?", "needed": "Green-MED versus HDG and MED versus HDG, and adjustment status", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are other contrasts and unadjusted or adjusted effects kept separate?", "application_exception": "The ordering of the three proportional reductions does not establish significance for every between-group comparison.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Green-MED versus HDG and MED versus HDG, and adjustment status.", "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research specifying group changes and planned comparisons", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The current summary specifies a significant P value only for weight-adjusted green-MED versus MED. Exact effects, CIs and P values for green-MED versus HDG, MED versus HDG and unadjusted comparisons are not separately established.", "condition_status": "Unverified", "status_reason": "Required direct material has not been established within the current summary and unread external-material scope. Other contrasts, unadjusted results, multiplicity handling and CIs are unverified.", "missingness": "Other contrasts, unadjusted results, multiplicity handling and CIs are unverified.", "uncertainty": "Other contrasts, unadjusted results, multiplicity handling and CIs are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Analysis tables by contrast and adjustment status" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "What numerical scope supports the historical wording of a small standardized effect?", "needed": "Original small-effect wording and exact standardized values and CIs", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What numerical scope supports the historical wording of a small standardized effect?", "application_exception": "Original E~, unrecorded precision and small-effect wording are historical values, not current recalculation or regrading results.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Original small-effect wording and exact standardized values and CIs.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is internally designed; M15 §15.3.1–15.3.3; internal application", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research prespecifying the effect of interest, precision and importance", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The parent text describes a small standardized effect versus conventional MED. Exact standardized values, formulas and CIs are absent from the summary; no new d or effect grade is created.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. Standardized-effect units, definitions, values, CIs and importance thresholds are unverified.", "missingness": "Standardized-effect units, definitions, values, CIs and importance thresholds are unverified.", "uncertainty": "Standardized-effect units, definitions, values, CIs and importance thresholds are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original adjusted and standardized results and importance thresholds" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "What are the total 294 randomized participants and group denominators?", "needed": "Total allocation, group allocation and analysis, and time-specific denominators", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What are the total 294 randomized participants and group denominators?", "application_exception": "The total is not divided by the number of groups, and participant counts are not newly added or estimated.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Total allocation, group allocation and analysis, and time-specific denominators.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research distinguishing allocation from measurement and analysis denominators", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original total of 294 randomized participants is preserved. Group allocation, MRS analysis and valid contrast-specific denominators are not separately presented in the summary.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. Denominators by group, time point, outcome and adjusted model are unverified.", "missingness": "Denominators by group, time point, outcome and adjusted model are unverified.", "uncertainty": "Denominators by group, time point, outcome and adjusted model are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant flow and group-specific and analysis-specific denominator tables" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Are 89.8% retention, 78% eligible MRS and the original 22% distinguished?", "needed": "Overall follow-up retention, imaging eligibility and original missingness wording", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are 89.8% retention, 78% eligible MRS and the original 22% distinguished?", "application_exception": "Original proportions are not converted into new participant counts or attrition rates, and 22% is not calculated from 89.8%.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Overall follow-up retention, imaging eligibility and original missingness wording.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design; M08 §8.2.2, M15 §15.3.1; own application; M19 §19.1.2–19.2.4, M04 §4.6.3; own application", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Plans distinguishing clinical follow-up from measurement eligibility", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The evidence list separately records 89.8% retention at 18 months and 78% eligible follow-up MRS. The original 22% in the parent rationale is preserved as absence of eligible MRS. Retention and imaging eligibility are not presented as the same status.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. Exact denominators for each proportion, group counts and reasons for ineligibility or missingness are unverified.", "missingness": "Exact denominators for each proportion, group counts and reasons for ineligibility or missingness are unverified.", "uncertainty": "Exact denominators for each proportion, group counts and reasons for ineligibility or missingness are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Follow-up retention and imaging eligibility flows with group-specific reasons" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Are subgroup and baseline liver-fat analysis denominators available?", "needed": "Overall MRS population and denominators by subgroup and baseline status", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are subgroup and baseline liver-fat analysis denominators available?", "application_exception": "The overall 294 participants or 78% are not copied as analysis counts for every subgroup.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Overall MRS population and denominators by subgroup and baseline status.", "basis": "M03 §3.2.1; detailed population conditions are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research distinguishing overall and subgroup effects of interest", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The summary does not provide exact counts or analysis scope showing which baseline liver-fat levels or disease subgroups contributed valid observations to the current findings.", "condition_status": "Unverified", "status_reason": "Required direct material has not been established within the current summary and unread external-material scope. Subgroup eligibility, group denominators, prespecified plans and interactions are unverified.", "missingness": "Subgroup eligibility, group denominators, prespecified plans and interactions are unverified.", "uncertainty": "Subgroup eligibility, group denominators, prespecified plans and interactions are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Subgroup analysis tables and baseline and follow-up MRS denominators" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Were imaging missingness, eligibility exclusions and analysis populations established?", "needed": "Reasons for missing MRS, analysis populations, imputation and sensitivity analyses", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Were imaging missingness, eligibility exclusions and analysis populations established?", "application_exception": "All absent imaging is not recast as attrition or harm events, or treated as zero effect.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Reasons for missing MRS, analysis populations, imputation and sensitivity analyses.", "basis": "M08 §8.2.2, M15 §15.3.1; Internal application; M08 Table 8.2.a, M04 §4.6.3; Internal application", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Prespecified plans for imaging missingness and the effect of interest", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original text records 78% eligible follow-up MRS and imaging missingness limitations. ITT, complete-case analysis, ineligibility, imputation and sensitivity details are not presented.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. Missingness and eligibility-exclusion reasons, group differences, imputation, sensitivity analyses and analysis populations are unverified.", "missingness": "Missingness and eligibility-exclusion reasons, group differences, imputation, sensitivity analyses and analysis populations are unverified.", "uncertainty": "Missingness and eligibility-exclusion reasons, group differences, imputation, sensitivity analyses and analysis populations are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "SAP, imaging eligibility flow and missing-data analyses" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "What were three-group randomization, allocation concealment and baseline balance?", "needed": "Random sequence, concealment and three-group baseline information", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What were three-group randomization, allocation concealment and baseline balance?", "application_exception": "The RCT label and historical parent B1/I1 axes do not certify adequate allocation or absence of bias in a current review.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Random sequence, concealment and three-group baseline information.", "basis": "M08 §8.1–8.2.3; own application", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research with explicit three-group allocation, population and effects of interest", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original design is a three-arm 18-month randomized lifestyle trial. Actual allocation and concealment methods and baseline balance are not described in detail in the summary.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. Sequence generation, concealment, allocation responsibility and baseline balance are unverified.", "missingness": "Sequence generation, concealment, allocation responsibility and baseline balance are unverified.", "uncertainty": "Sequence generation, concealment, allocation responsibility and baseline balance are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation procedures, baseline tables and protocol" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Were MRS masking, standardization and assessment procedures established?", "needed": "Equipment, reader and time-point masking, and measurement consistency", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Were MRS masking, standardization and assessment procedures established?", "application_exception": "Objective imaging alone does not establish absence of measurement influences or bias.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Equipment, reader and time-point masking, and measurement consistency.", "basis": "M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M08 §§8.1–8.2.3; Chamgap adaptation", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research with designated measurement and reading plans", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Use of proton MRS is preserved, but the summary does not provide assessor or reader masking, equipment and location standardization or reliability over time.", "condition_status": "Unverified", "status_reason": "Required direct material has not been established within the current summary and unread external-material scope. Measurement, reading, eligibility adjudication, masking and error ranges are unverified.", "missingness": "Measurement, reading, eligibility adjudication, masking and error ranges are unverified.", "uncertainty": "Measurement, reading, eligibility adjudication, masking and error ranges are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "MRS methods and reading and eligibility procedures" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "What were common exposures from baseline disease, medication and lifestyle?", "needed": "Concurrent treatment, baseline status and common support and activity", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What were common exposures from baseline disease, medication and lifestyle?", "application_exception": "Unknown medications or diseases, or treatment replacement, are not added as original study components.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Concurrent treatment, baseline status and common support and activity.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research specifying common exposures and allocation contrasts", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original text records physical activity in all groups and walnuts in both MED groups. Group-specific medication, comorbidity and other lifestyle-change details are not presented.", "condition_status": "Unverified", "status_reason": "Required direct material has not been established within the current summary and unread external-material scope. Baseline and changed medications, diseases, concurrent exposures and support differences are unverified.", "missingness": "Baseline and changed medications, diseases, concurrent exposures and support differences are unverified.", "uncertainty": "Baseline and changed medications, diseases, concurrent exposures and support differences are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Medical history, medication, lifestyle and support records" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are weight loss, adherence, component contributions and effects of interest distinguished?", "needed": "Boundaries of weight adjustment, dietary adherence and single-component attribution", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are weight loss, adherence, component contributions and effects of interest distinguished?", "application_exception": "The adjusted P value and similar weight loss do not certify Mankai or green-tea efficacy alone.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Boundaries of weight adjustment, dietary adherence and single-component attribution.", "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.4; internally defined extension boundaries", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research distinguishing the bundled pattern from component and mediation questions", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Similar weight loss in both MED groups and the adjusted direction are preserved as originally described. These are not separated causal findings identifying a particular component or pathway beyond weight change.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. Weight and adherence models, mediation and component-specific effects of interest, and isolated-component comparisons are unverified.", "missingness": "Weight and adherence models, mediation and component-specific effects of interest, and isolated-component comparisons are unverified.", "uncertainty": "Weight and adherence models, mediation and component-specific effects of interest, and isolated-component comparisons are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Adjustment and adherence material and component-specific designs and analyses" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are registration, outcome hierarchy, reports and prior plans distinguished?", "needed": "NCT03020186 identification, actual plan reading and primary-outcome hierarchy", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are registration, outcome hierarchy, reports and prior plans distinguished?", "application_exception": "Identifiers, original outcome labels and false axis flags alone do not certify prespecified primary status or reading of registration content.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: NCT03020186 identification, actual plan reading and primary-outcome hierarchy.", "basis": "M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.5–4.6 material collection and selection principles; separation of access and reading and the hyperlink contract are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research preserving designated outcomes, effects of interest and plan changes", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The evidence and citation lists record NCT03020186. MRS change in the original classification fields and historical registration-verification wording are preserved, but external registration, protocol and SAP material was not read in this work.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. Registration versions and timing, prespecified outcome hierarchy, analysis and multiplicity plans, and reporting changes are unverified.", "missingness": "Registration versions and timing, prespecified outcome hierarchy, analysis and multiplicity plans, and reporting changes are unverified.", "uncertainty": "Registration versions and timing, prespecified outcome hierarchy, analysis and multiplicity plans, and reporting changes are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration versions, protocol, SAP and material comparing plans with results" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "How are identities of reports, trials, groups and time points linked?", "needed": "DIRECT-PLUS report identity and duplicate observations and participants", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are identities of reports, trials, groups and time points linked?", "application_exception": "The one currently linked report is not a total count of independent trials or new independence certification.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: DIRECT-PLUS report identity and duplicate observations and participants.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Records distinguishing reports from the same study family", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "One existing evidence entry and one citation for Yaskolka Meir2021 DIRECT-PLUS are linked as one report. The three groups, 18 months, other time points and sibling questions are not added as new independent trials or participants.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. Relationships among other DIRECT-PLUS reports or populations and totals of unique trials and participants are unverified.", "missingness": "Relationships among other DIRECT-PLUS reports or populations and totals of unique trials and participants are unverified.", "uncertainty": "Relationships among other DIRECT-PLUS reports or populations and totals of unique trials and participants are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Identity material linking related reports, trials and participants" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Is independent confirmation or direct replication available?", "needed": "Independent studies and trial relationships for the same bundled-diet question", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Is independent confirmation or direct replication available?", "application_exception": "Original absence wording is not promoted into a current worldwide absence check, and reports from the same trial are not counted as independent replication.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Independent studies and trial relationships for the same bundled-diet question.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Separate confirmation research explicitly addressing the same question", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original counterview states that independent confirmation trials are absent, while parent R1/I1 are historical axes. Other studies were not searched for or certified during this production.", "condition_status": "Unverified", "status_reason": "Required direct material has not been established within the current summary and unread external-material scope. Current external search scope, independent report identities and duplication are unverified.", "missingness": "Current external search scope, independent report identities and duplication are unverified.", "uncertainty": "Current external search scope, independent report identities and duplication are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct replication reports and trial identity material" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Can effects by component, other dietary patterns or subgroup be established?", "needed": "Direct comparisons of the bundled pattern with isolated components or other populations", "role": "Supplementary", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Can effects by component, other dietary patterns or subgroup be established?", "application_exception": "The advertising example of 39% is not adopted as a new trial figure or component effect.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Direct comparisons of the bundled pattern with isolated components or other populations.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research distinguishing dietary-pattern contrasts from individual-component questions", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The isolated-component question has grade ? and a note that individual component effects were not separated. Findings from the bundled diet are not attributed to Mankai, green tea or walnuts alone, or to other diets or subgroups.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. Direct effects and CIs for isolated components, other patterns and population-specific comparisons are unverified.", "missingness": "Direct effects and CIs for isolated components, other patterns and population-specific comparisons are unverified.", "uncertainty": "Direct effects and CIs for isolated components, other patterns and population-specific comparisons are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct comparisons of components and other patterns" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Which clinical outcomes does MRS liver fat address?", "needed": "Surrogates, liver-disease events and patient-important outcomes", "role": "Supplementary", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Which clinical outcomes does MRS liver fat address?", "application_exception": "No new liver-disease management or treatment-replacement instructions or disease-event prevention efficacy are created.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Surrogates, liver-disease events and patient-important outcomes.", "basis": "M03 §3.2.4; internally defined extension boundaries", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Plans distinguishing MRS from clinical events", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original text identifies intrahepatic fat as a surrogate and states that clinical liver-disease events are absent. MRS change does not establish direct effects on liver-disease treatment, progression, fibrosis, hospitalization or quality of life.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. Direct clinical events, function, quality of life, follow-up, denominators and CIs are unverified.", "missingness": "Direct clinical events, function, quality of life, follow-up, denominators and CIs are unverified.", "uncertainty": "Direct clinical events, function, quality of life, follow-up, denominators and CIs are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Material directly measuring clinical liver-disease outcomes" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "What are the boundaries of the original long-term wording, persistence and extrapolation?", "needed": "18-month results, post-treatment follow-up and other long-term exposures", "role": "Supplementary", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What are the boundaries of the original long-term wording, persistence and extrapolation?", "application_exception": "18 months is not recast as a lifelong management effect or a recommended diet for every liver-disease population.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: 18-month results, post-treatment follow-up and other long-term exposures.", "basis": "M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap’s own design; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research distinguishing persistence from extrapolation questions", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The parent text describes strengths of the 18-month duration. Findings do not guarantee persistence after stopping, longer follow-up or efficacy in other populations or environments.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. Direct effects after stopping, during longer follow-up and in other populations are unverified.", "missingness": "Direct effects after stopping, during longer follow-up and in other populations are unverified.", "uncertainty": "Direct effects after stopping, during longer follow-up and in other populations are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term, post-treatment and population-specific outcome material" }, { "item_id": "N30", "question_type": "Evidence condition", "question": "What original information describes mixed funding and product interests?", "needed": "Public and industry funding, advisory roles and funder involvement", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What original information describes mixed funding and product interests?", "application_exception": "Reported non-involvement is not recast as current certification of no interests, and support alone does not lead to a verdict of ineffective treatment.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Public and industry funding, advisory roles and funder involvement.", "basis": "Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item; M08 §8.1–8.2.3; internal application", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Explicit reporting of funding and decision-making and analysis roles", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Original funding wording describes German, Israeli and EU public support, California Walnut Commission support, the PI's disclosed Hinoman advisory role and funders' reported lack of involvement in design or analysis. Original disclosures have not been newly checked externally.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. Original disclosure details, product provision or access, and analysis roles are unverified.", "missingness": "Original disclosure details, product provision or access, and analysis roles are unverified.", "uncertainty": "Original disclosure details, product provision or access, and analysis roles are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Funding, interests, in-kind contributions and support-role disclosures" }, { "item_id": "N31", "question_type": "Evidence condition", "question": "What do stored-summary reading, external reading and URL access indicators mean?", "needed": "Reading scope of the complete stored summary, abstract, full text, registration and needed material", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What do stored-summary reading, external reading and URL access indicators mean?", "application_exception": "The presence of a link, PMCID or NCT identifier is not assigned acquisition, reading or successful-access status.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Reading scope of the complete stored summary, abstract, full text, registration and needed material.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Production records distinguishing stored summaries from newly acquired material", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The complete stored summary for 2984 was read for production and preserved as a copy. The PubMed URL, PMCID and registration identifier are original source links; external content reading, access and link testing were not performed.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. Current checks of external methods, results, registration and material content remain incomplete.", "missingness": "Current checks of external methods, results, registration and material content remain incomplete.", "uncertainty": "Current checks of external methods, results, registration and material content remain incomplete.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actually acquired original material and reading and addition-event records" }, { "item_id": "N32", "question_type": "Evidence condition", "question": "What are the original Korean and English text, cut-off, empty values and historical axes?", "needed": "Original language versions, dates, corrections, axes and parent verdict", "role": "Required", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What are the original Korean and English text, cut-off, empty values and historical axes?", "application_exception": "Historical Codex full-text, registry and scoring verification wording is not inherited as a current passed external reading or content review.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Original language versions, dates, corrections, axes and parent verdict.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Separation of original values from new material and changes", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Complete Korean and English text, original cut-off 2026-09-07, an empty corrections array and empty deliberation text are preserved. Parent C with 46 points, B/S/R1/I1/E~/B1, unrecorded precision, four false flags and empty override reasons are historical context, not current review or regrading results.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. External detailed translation, corrections and registration comparisons were not performed in this work.", "missingness": "External detailed translation, corrections and registration comparisons were not performed in this work.", "uncertainty": "External detailed translation, corrections and registration comparisons were not performed in this work.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original texts, language-specific changes, dates and correction events" }, { "item_id": "N33", "question_type": "Evidence condition", "question": "How were adverse events collected?", "needed": "Event definitions, active or passive collection, severity and denominators", "role": "Supplementary", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How were adverse events collected?", "application_exception": "Not being central is not recast as zero adverse events or confirmed absence of actual collection.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Event definitions, active or passive collection, severity and denominators.", "basis": "M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research with explicit harm ascertainment alongside efficacy", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original safety explanation states that adverse-event ascertainment was not central to the efficacy report. Actual event definitions, collection methods, scope, severity and event tables are absent from the summary.", "condition_status": "Unverified", "status_reason": "Required direct material has not been established within the current summary and unread external-material scope. Harm ascertainment and definitions, and complete event findings are unverified.", "missingness": "Harm ascertainment and definitions, and complete event findings are unverified.", "uncertainty": "Harm ascertainment and definitions, and complete event findings are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm plans, symptom and event tables and discontinuation criteria" }, { "item_id": "N34", "question_type": "Evidence condition", "question": "Do nut-allergy and caffeine-sensitivity statements describe actual events?", "needed": "Original cautionary context distinguished from collected harms", "role": "Supplementary", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Do nut-allergy and caffeine-sensitivity statements describe actual events?", "application_exception": "No new intake, product avoidance or recommendation, disease-specific diet or treatment instructions are written.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Original cautionary context distinguished from collected harms.", "basis": "M19 §19.1.2–19.2.4; detailed distinctions are internally designed; Internally defined Chamgap interpretation boundaries, referring to M19 principles without applying an official causality tool; M19 §19.1.2–19.2.4; internal application", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Safety questions specifying the relevant vulnerable scope", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original text separately mentions nut allergy, caffeine sensitivity and disease-specific dietary suitability. This is not a quantitative or causal finding that a particular event occurred in this trial.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. Enrollment, events, condition-specific denominators and severity in the relevant populations are unverified.", "missingness": "Enrollment, events, condition-specific denominators and severity in the relevant populations are unverified.", "uncertainty": "Enrollment, events, condition-specific denominators and severity in the relevant populations are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual population, harm and relatedness material" }, { "item_id": "N35", "question_type": "Evidence condition", "question": "Were group-specific harm events, denominators and comparisons established?", "needed": "Valid harm ascertainment in three groups, event and exposure denominators and effects", "role": "Supplementary", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Were group-specific harm events, denominators and comparisons established?", "application_exception": "No new zero-event counts, zero incidence, risk differences or CIs are calculated.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Valid harm ascertainment in three groups, event and exposure denominators and effects.", "basis": "M19 §19.2.2–19.2.4, M03 §3.2.3; internal application; M19 §19.1.2–19.2.4; internal application", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research distinguishing efficacy measurements from harm-collection populations", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The summary lacks group-specific harm events and collection denominators. The total 294 participants, retention and eligible MRS are not automatically used as harm-analysis denominators.", "condition_status": "Unverified", "status_reason": "Required direct material has not been established within the current summary and unread external-material scope. Harm denominators, effects and CIs by group, event and period are unverified.", "missingness": "Harm denominators, effects and CIs by group, event and period are unverified.", "uncertainty": "Harm denominators, effects and CIs by group, event and period are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm flow and arm-specific event/denominator tables" }, { "item_id": "N36", "question_type": "Evidence condition", "question": "What were harm timing, exposure duration and delayed follow-up?", "needed": "Time-specific symptoms and harm observation after discontinuation or study end", "role": "Supplementary", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What were harm timing, exposure duration and delayed follow-up?", "application_exception": "18-month efficacy follow-up is not recast as completed verification of long-term safety.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Time-specific symptoms and harm observation after discontinuation or study end.", "basis": "M19 §19.2 design-specific harm questions; temporal-relationship details are internally designed; M19 §19.1.2–19.2.4; internal application", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research with symptom, timing and delayed-observation plans", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "An 18-month lifestyle trial is described, but the summary lacks harm onset times, repeated exposure and post-treatment or delayed harm observation.", "condition_status": "Unverified", "status_reason": "Required direct material has not been established within the current summary and unread external-material scope. Harm timing and observation, exposure changes and post-treatment findings are unverified.", "missingness": "Harm timing and observation, exposure changes and post-treatment findings are unverified.", "uncertainty": "Harm timing and observation, exposure changes and post-treatment findings are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Time-specific harm, exposure and follow-up material" }, { "item_id": "N37", "question_type": "Evidence condition", "question": "How is harm attribution handled for the bundled diet, common exposures and medical history?", "needed": "Food, activity, concurrent medication, disease and event causality", "role": "Supplementary", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How is harm attribution handled for the bundled diet, common exposures and medical history?", "application_exception": "General food-risk warnings are not recast as confirmed causes or events in this trial.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Food, activity, concurrent medication, disease and event causality.", "basis": "M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Harm research distinguishing bundled interventions from alternative causes", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The diet was bundled, with common physical-activity and walnut exposures. Actual causal or relatedness material attributing harms to a particular food or the whole diet was not provided.", "condition_status": "Unverified", "status_reason": "Required direct material has not been established within the current summary and unread external-material scope. Event-specific exposure, history, concurrent medication, relatedness assessment and alternative causes are unverified.", "missingness": "Event-specific exposure, history, concurrent medication, relatedness assessment and alternative causes are unverified.", "uncertainty": "Event-specific exposure, history, concurrent medication, relatedness assessment and alternative causes are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual event, exposure, history and relatedness records" }, { "item_id": "N38", "question_type": "Evidence condition", "question": "Are retention, imaging missingness, harms and discontinuation reasons distinguished?", "needed": "Harm-related discontinuation, missingness and ineligibility reasons, and collection", "role": "Supplementary", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are retention, imaging missingness, harms and discontinuation reasons distinguished?", "application_exception": "The original 22% is not converted into an adverse-effect rate or a count of participants lost to follow-up.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Harm-related discontinuation, missingness and ineligibility reasons, and collection.", "basis": "M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "A plan separating missingness from harm-related discontinuation", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Original retention of 89.8% and eligible MRS of 78% are recorded. Harm, motivation and examination-related reasons for each missing or ineligible observation, and harm collection in participants with missing data, remain unverified.", "condition_status": "Unverified", "status_reason": "Required direct material has not been established within the current summary and unread external-material scope. Group-specific missingness and discontinuation reasons, relationships to harms and collection of missing harm data are unverified.", "missingness": "Group-specific missingness and discontinuation reasons, relationships to harms and collection of missing harm data are unverified.", "uncertainty": "Group-specific missingness and discontinuation reasons, relationships to harms and collection of missing harm data are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant and imaging flows, discontinuation reasons and harm material" }, { "item_id": "N39", "question_type": "Evidence condition", "question": "Were independent harm studies or separate event material acquired?", "needed": "Independent safety material matching the diet, population and exposure", "role": "Supplementary", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Were independent harm studies or separate event material acquired?", "application_exception": "Absence of a separate current slot does not establish worldwide absence of harm reports.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Independent safety material matching the diet, population and exposure.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Independent harm research with explicit population and dietary exposure", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The current preserved list contains this one efficacy report. Independent original harm material was not searched for or acquired here, and results from the same trial are not counted as a separate harm trial.", "condition_status": "Unverified", "status_reason": "Required direct material has not been established within the current summary and unread external-material scope. Independent harm-report identity, populations, exposures and duplication are unverified.", "missingness": "Independent harm-report identity, populations, exposures and duplication are unverified.", "uncertainty": "Independent harm-report identity, populations, exposures and duplication are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate harm studies, surveillance and event reports" }, { "item_id": "N40", "question_type": "Evidence condition", "question": "What are the safety boundaries for vulnerable populations, baseline liver disease and long-term exposure?", "needed": "Subtypes, disease, medication, allergy, sensitivity and long-term observation", "role": "Supplementary", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What are the safety boundaries for vulnerable populations, baseline liver disease and long-term exposure?", "application_exception": "No new dietary management, product or intake, weight-management or liver-disease treatment-replacement guidance is produced.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Subtypes, disease, medication, allergy, sensitivity and long-term observation.", "basis": "M19 §19.1.2–19.2.4; Internal application; Design considerations in M19 §19.2.2–19.2.4; Detailed confounding records are internally designed", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research specifying population and long-term safety questions", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Original wording separately mentions individual disease, dietary suitability, allergy and sensitivity. Safety findings in particular liver-disease subtypes, vulnerable populations or longer exposures are not presented.", "condition_status": "Unverified", "status_reason": "Required direct material has not been established within the current summary and unread external-material scope. Population-specific history, medication, exposure, direct events and follow-up are unverified.", "missingness": "Population-specific history, medication, exposure, direct events and follow-up are unverified.", "uncertainty": "Population-specific history, medication, exposure, direct events and follow-up are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct harm material for vulnerable and disease-specific populations" }, { "item_id": "N41", "question_type": "Evidence condition", "question": "Are liver-fat reduction, unknown safety and causal judgments distinguished?", "needed": "Efficacy surrogates, original safety and comparative harms", "role": "Supplementary", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are liver-fat reduction, unknown safety and causal judgments distinguished?", "application_exception": "Unknown is not recast as zero events, confirmed harm or guaranteed safety.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Efficacy surrogates, original safety and comparative harms.", "basis": "Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool; M03 §3.2.4; Internally defined extrapolation boundaries", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research separating safety from surrogate effects of interest", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Parent safety is unknown. Liver-fat reduction does not establish comparative safety, clinical liver-disease events or component-specific causal safety.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. Direct comparative events, causality, precision and long-term harm findings are unverified.", "missingness": "Direct comparative events, causality, precision and long-term harm findings are unverified.", "uncertainty": "Direct comparative events, causality, precision and long-term harm findings are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm and clinical-event material separate from efficacy" }, { "item_id": "N42", "question_type": "Evidence condition", "question": "How are later material, condition versions and original values updated?", "needed": "Identity, population, comparator, units, denominators, timing, reading and change events", "role": "Supplementary", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are later material, condition versions and original values updated?", "application_exception": "Production completion does not establish completed clinical review or publication.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Identity, population, comparator, units, denominators, timing, reading and change events.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research addressing direct gaps in the selected bundled-diet question", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The complete stored summary is preserved and conditions are saved and frozen before separate application. Additional material is linked to events distinguishing absolute and proportional values, adjustment, denominators, populations, comparisons, original values and actual reading.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. Later original material and actual reading or change events are not yet available.", "missingness": "Later original material and actual reading or change events are not yet available.", "uncertainty": "Later original material and actual reading or change events are not yet available.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional original material, before and after values and condition-version change records" }, { "item_id": "N43", "question_type": "Evidence condition", "question": "How are historical candidate records distinguished from current content-review status?", "needed": "Historical candidate records, production status and new-unit counts", "role": "Supplementary", "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are historical candidate records distinguished from current content-review status?", "application_exception": "Historical full-text, registration and scoring verification wording is not invented as a current passed clinical review or external reading.", "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Historical candidate records, production status and new-unit counts.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Records distinguishing the original question, production and review decisions", "current_reports": [ "R01" ], "existence": "Stored summary of the bundled diet available; external originals and direct details are unread or needed material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Original candidate review-pending and eligibility indicators are preserved. No new model, content or question-boundary review was performed; incomplete review, false completion flags, zero new units and unrecorded final independent counts are retained.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish completed clinical verification or content review. Later review decisions and final independence counts remain unresolved.", "missingness": "Later review decisions and final independence counts remain unresolved.", "uncertainty": "Later review decisions and final independence counts remain unresolved.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Review and change-decision records" } ], "reports": [ { "report_id": "R01", "title": "Yaskolka Meir A, Rinott E, Tsaban G, et al. Effect of green-Mediterranean diet on intrahepatic fat: the DIRECT PLUS randomised controlled trial. Gut. 2021;70(11):2085-2095. PMID: 33461965. PMCID: PMC8515100. DOI: 10.1136/gutjnl-2020-323106. NCT03020186.", "url": "https://pubmed.ncbi.nlm.nih.gov/33461965/", "report_type": "Stored report of three-group 18-month MRS results from the DIRECT-PLUS bundled lifestyle trial", "existence": "Bibliography and stored summary available; external original papers, registration and details remain unread", "acquired_read": "Summary read; external materials unread, access not attempted", "study_family": "SF01", "independent_replication": "The same trial groups, time points and parent or sibling questions are not added as new independent trials or participants. No new totals of unique clinical trials or participants are certified.", "observed_result": "Green-MED -38.9%, MED -19.6%, HDG -12.2%; weight-adjusted green-MED versus MED P=.035", "result_level": "18-month proportional MRS changes for a bundled diet and the weight-adjusted green-MED versus MED P value. Absolute or adjusted effect estimates, CIs and group or subgroup denominators are unverified. These are not isolated-component or clinical liver-disease event results.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored summary", "public_status": "Local preserved summary", "access_status": "Summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "Acquisition and reading of the complete parent summary only, not original external papers or registration material." }, { "material_type": "Abstract", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the original citation link is provided. External access, content checking and link testing were not attempted." }, { "material_type": "Full paper", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original PMCID reference is retained; full-text content has not been newly obtained or read." }, { "material_type": "Registration material", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original NCT03020186 identifier preserved. Registration versions and content are unread; access was not attempted." }, { "material_type": "Protocol", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original plans for intervention and comparator, MRS eligibility, outcome hierarchy and harms are needed. Existence and public availability are unverified." }, { "material_type": "Statistical analysis plan", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original plans concerning adjustment, effects of interest, imaging missingness, contrasts and subgroups are needed." }, { "material_type": "Result tables and MRS, denominator and harm records", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original absolute and proportional results, groups and time points, baseline and subgroup information, retention, imaging eligibility and harm material are needed. No new calculations are produced." }, { "material_type": "Funding/conflict-of-interest disclosures", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original disclosures of public and industry support, advisory roles and funder involvement are currently unread." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/33461965/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Preserved records of methodological application were referenced. Methodological source content was not newly reviewed in this work." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Preserved records of methodological application were referenced. Methodological source content was not newly reviewed in this work." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Preserved records of methodological application were referenced. Methodological source content was not newly reviewed in this work." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Preserved records of methodological application were referenced. Methodological source content was not newly reviewed in this work." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Preserved records of methodological application were referenced. Methodological source content was not newly reviewed in this work." } ], "status_dictionary": { "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." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "Yaskolka Meir2021 DIRECT-PLUS links the same report and trial across three groups, 18 months, the parent verdict, bundled-diet question and isolated-component question. Other groups, time points and components are not newly added to independent-trial or participant totals." }, "history": [ { "date": "2026-10-15", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public pages and materials were prepared from the existing 43 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-15" }