{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2946-s1", "verdict_number": "2946", "title": "Ad libitum low-fat vegan composite diet × Superior weight loss versus another healthful diet — Comparator-specific evidence checklist", "view_version": "1.0", "view_created_date": "2026-10-11", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The complete existing review summary was read for production, linking existing URLs and identifiers. External abstracts, full texts, registration, protocols and SAP were not newly read or checked.", "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": "The original sixteen-week population of overweight adults, the seventy-four-week type 2 diabetes population, and NEW Soul's African American population are distinguished; detailed eligibility remains unread", "intervention": "Historical study intervention using an ad libitum low-fat vegan composite diet; this does not establish individual-component effects or provide dietary instructions for readers", "dose": "Original sixteen-week dietary education, weekly classes and support, and no food or supplement provision are preserved as history; detailed actual intake and calories remain unverified", "comparator": "The seventy-four-week conventional diabetes diet and twelve-month low-fat omnivorous soul food comparisons are separated; the sixteen-week trial had a no-change control", "endpoint": "Selected superiority in weight loss versus active healthy diets; endpoint, nonsignificance, and equivalence boundaries are retained", "duration": "Active comparisons at seventy-four weeks and twelve months; detailed evidence for an active comparison in the same original sixteen-week population remains a gap", "excluded_extensions": [ "Transferring the sixteen-week no-change effect to superiority over all active healthy diets", "Confirming effects of individual components, all vegan diets, or all healthy diets", "Certifying zero for all differences or equivalence from nonsignificance", "Extending results to long-term maintenance, disease, death, or diabetes treatment", "Diet, weight-loss, exercise, medication-change, or treatment instructions" ] }, "requirements": [ { "item_id": "N01", "question_type": "Comparative efficacy", "question": "Are the selected superiority claim against active healthy diets and the parent's no-change effect separated?", "needed": "Separate records of the selected wording, grade, note, and parent comparison", "role": "Required", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Separate records of the selected wording, grade, note, and parent comparison", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "If additional materials are provided, distinguish and connect results matched to comparator, population, and duration.", "current_reports": [ "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The original subclaim is ‘Superior weight loss versus another healthful diet’, with original grade D and a note of 74-week diabetes-diet trial P=0.25. The parent is C, 54, Caution.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Absent subclaim score, status, and assessment axes are not filled with parent values. Null effects across all other healthy diets are not newly certified.", "missingness": "Absent subclaim score, status, and assessment axes are not filled with parent values. Null effects across all other healthy diets are not newly certified.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Absent subclaim score, status, and assessment axes are not filled with parent values. Null effects across all other healthy diets are not newly certified." }, { "item_id": "N02", "question_type": "Comparative efficacy", "question": "Which diets were actually meant by the comparator ‘another healthful diet’?", "needed": "Composition, education, exposure, support, and denominators for a specific active diet", "role": "Required", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Composition, education, exposure, support, and denominators for a specific active diet", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain original descriptions, common management, and actual intake materials for each active diet.", "current_reports": [ "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The original active controls were a conventional diabetes diet over 74 weeks and NEW Soul's low-fat omnivorous soul food diet.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. All other healthy diets are not treated as one identical comparator. Detailed composition, exposure, and education for each diet remain unread.", "missingness": "All other healthy diets are not treated as one identical comparator. Detailed composition, exposure, and education for each diet remain unread.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "All other healthy diets are not treated as one identical comparator. Detailed composition, exposure, and education for each diet remain unread." }, { "item_id": "N03", "question_type": "Comparative efficacy", "question": "Was the actual control in the sixteen-week trial an active healthy diet?", "needed": "Identity of the control and direct comparison in the relevant sixteen-week trial", "role": "Required", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Identity of the control and direct comparison in the relevant sixteen-week trial", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "If materials on a specific active healthy-diet control in the same population and duration are provided, connect them separately.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The 16-week trial of 244 participants compared 122 assigned to a vegan diet with 122 assigned to no diet change.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. The direct −5.9kg result does not fill the gap in superiority over another healthy diet in the same population at sixteen weeks.", "missingness": "The direct −5.9kg result does not fill the gap in superiority over another healthy diet in the same population at sixteen weeks.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The direct −5.9kg result does not fill the gap in superiority over another healthy diet in the same population at sixteen weeks." }, { "item_id": "N04", "question_type": "Comparative efficacy", "question": "What were the population and denominators for the seventy-four-week diabetes-diet comparison?", "needed": "Type 2 diabetes population, eligibility, and group allocation and analysis denominators", "role": "Required", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Type 2 diabetes population, eligibility, and group allocation and analysis denominators", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain original eligibility, baseline status, group denominators, and concomitant-treatment tables.", "current_reports": [ "R02" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The 74-week trial is recorded as randomizing 99 participants with type 2 diabetes.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. This is not transferred to the same population as general overweight adults. Eligibility, group allocation and analysis, baseline weight, and treatment details remain unread.", "missingness": "This is not transferred to the same population as general overweight adults. Eligibility, group allocation and analysis, baseline weight, and treatment details remain unread.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "This is not transferred to the same population as general overweight adults. Eligibility, group allocation and analysis, baseline weight, and treatment details remain unread." }, { "item_id": "N05", "question_type": "Comparative efficacy", "question": "What were the composite components and accompanying management of the seventy-four-week intervention and control?", "needed": "Original records of low-fat vegan and conventional diabetes diets, education, and concomitant treatment", "role": "Required", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Original records of low-fat vegan and conventional diabetes diets, education, and concomitant treatment", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain records of each composite diet's composition, actual intake, contact, and concomitant treatment.", "current_reports": [ "R02" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The original study design was a randomized trial of a low-fat vegan diet versus a conventional diabetes diet.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Calories, nutritional composition, attention, support, and medication changes are not newly assumed equal between groups. No dietary or medication instructions are created.", "missingness": "Calories, nutritional composition, attention, support, and medication changes are not newly assumed equal between groups. No dietary or medication instructions are created.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Calories, nutritional composition, attention, support, and medication changes are not newly assumed equal between groups. No dietary or medication instructions are created." }, { "item_id": "N06", "question_type": "Comparative efficacy", "question": "Are the seventy-four-week weight results and gaps in the between-group effect preserved?", "needed": "Group changes, between-group effect, CI, testing, and denominators", "role": "Required", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Group changes, between-group effect, CI, testing, and denominators", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain the original effect, interval, model, denominators, and weight-measurement methods.", "current_reports": [ "R02" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "At 74 weeks, weight changes were −4.4kg with the vegan diet versus −3.0kg with a conventional diabetes diet, between-group P=0.25.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. No new mean difference, CI, quantitative response, or NNT is calculated. The original between-group effect, CI, analysis model, and denominators are absent from the summary.", "missingness": "No new mean difference, CI, quantitative response, or NNT is calculated. The original between-group effect, CI, analysis model, and denominators are absent from the summary.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "No new mean difference, CI, quantitative response, or NNT is calculated. The original between-group effect, CI, analysis model, and denominators are absent from the summary." }, { "item_id": "N07", "question_type": "Comparative efficacy", "question": "Are seventy-four-week follow-up, attrition, ITT, and missing-data details directly verified?", "needed": "Group follow-up, analysis populations, reasons for missing data, sensitivity, and actual exposure", "role": "Required", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Group follow-up, analysis populations, reasons for missing data, sensitivity, and actual exposure", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain original participant flow, missing-data handling, analysis populations, and adherence materials for the seventy-four-week trial.", "current_reports": [ "R02" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The 74-week duration and 99 randomized participants are preserved.", "condition_status": "Unverified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Wording about 222 completers, repeated measures, and ITT including all participants concerns the sixteen-week trial and is not transferred to seventy-four weeks.", "missingness": "Wording about 222 completers, repeated measures, and ITT including all participants concerns the sixteen-week trial and is not transferred to seventy-four weeks.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Wording about 222 completers, repeated measures, and ITT including all participants concerns the sixteen-week trial and is not transferred to seventy-four weeks." }, { "item_id": "N08", "question_type": "Comparative efficacy", "question": "What were NEW Soul's actual population and application boundaries?", "needed": "Original materials on recruitment, baseline status, group denominators, and existing diet", "role": "Required", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Original materials on recruitment, baseline status, group denominators, and existing diet", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain original recruitment, eligibility, baseline status, and group denominators.", "current_reports": [ "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The NEW Soul bibliography specifies African Americans and records 159 randomized participants.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Detailed eligibility, including age, BMI, and comorbidities, remains unread. Results are not newly extended to all overweight adults or all regions.", "missingness": "Detailed eligibility, including age, BMI, and comorbidities, remains unread. Results are not newly extended to all overweight adults or all regions.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Detailed eligibility, including age, BMI, and comorbidities, remains unread. Results are not newly extended to all overweight adults or all regions." }, { "item_id": "N09", "question_type": "Comparative efficacy", "question": "What were the actual vegan and low-fat omnivorous soul food diets compared in NEW Soul?", "needed": "Composition, exposure, education, support, and accompanying management for the two composite diets", "role": "Required", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Composition, exposure, education, support, and accompanying management for the two composite diets", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain NEW Soul's original diet composition, contact, support, actual intake, and adherence.", "current_reports": [ "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The original study design was a randomized active-control trial of vegan versus low-fat omnivorous soul food diets.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Results are not generalized to all vegan diets or all omnivorous healthy diets, and the sixteen-week diet composition is not copied unchanged.", "missingness": "Results are not generalized to all vegan diets or all omnivorous healthy diets, and the sixteen-week diet composition is not copied unchanged.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Results are not generalized to all vegan diets or all omnivorous healthy diets, and the sixteen-week diet composition is not copied unchanged." }, { "item_id": "N10", "question_type": "Comparative efficacy", "question": "Is NEW Soul's twelve-month primary weight result preserved as recorded?", "needed": "Primary outcome, group changes, original between-group effect, CI, and testing", "role": "Required", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Primary outcome, group changes, original between-group effect, CI, and testing", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain the original primary-outcome plan, group denominators, effect, CI, and measurement materials.", "current_reports": [ "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "At 12 months, primary weight changes were −2.39kg with the vegan diet versus −2.03kg with the low-fat omnivorous diet, between-group P=.64.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. No new mean difference, response count, CI, or equivalence verdict is created. Group analysis denominators, original CI, and model remain unread.", "missingness": "No new mean difference, response count, CI, or equivalence verdict is created. Group analysis denominators, original CI, and model remain unread.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "No new mean difference, response count, CI, or equivalence verdict is created. Group analysis denominators, original CI, and model remain unread." }, { "item_id": "N11", "question_type": "Comparative efficacy", "question": "Are NEW Soul's long-term follow-up, denominators, and missing-data details directly presented?", "needed": "Records of allocation, twelve-month observations, ITT, attrition, missing data, and sensitivity", "role": "Required", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Records of allocation, twelve-month observations, ITT, attrition, missing data, and sensitivity", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain original participant flow, group missing data, ITT, analysis populations, and adherence materials.", "current_reports": [ "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The original materials record 159 randomized participants and 12-month results.", "condition_status": "Unverified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. The 159 randomized participants are not confirmed as the analysis denominator for every twelve-month result, and the sixteen-week 91.0% completion rate is not transferred.", "missingness": "The 159 randomized participants are not confirmed as the analysis denominator for every twelve-month result, and the sixteen-week 91.0% completion rate is not transferred.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The 159 randomized participants are not confirmed as the analysis denominator for every twelve-month result, and the sixteen-week 91.0% completion rate is not transferred." }, { "item_id": "N12", "question_type": "Comparative efficacy", "question": "Are nonsignificant P values in active comparisons distinguished from limits on superiority and equivalence?", "needed": "Effect, CI, importance, and prespecified superiority or equivalence plans", "role": "Required", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Effect, CI, importance, and prespecified superiority or equivalence plans", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Connect the relevant comparison scope when the original CI, testing plan, and importance threshold are provided.", "current_reports": [ "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The stored summary records that 74-week P=0.25 and NEW Soul P=.64 did not show superiority over active controls.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Without CI, thresholds, or an equivalence design, zero for every difference or equivalence with all healthy diets is not newly confirmed.", "missingness": "Without CI, thresholds, or an equivalence design, zero for every difference or equivalence with all healthy diets is not newly confirmed.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Without CI, thresholds, or an equivalence design, zero for every difference or equivalence with all healthy diets is not newly confirmed." }, { "item_id": "N13", "question_type": "Comparative efficacy", "question": "Does the direct-evidence gap remain for an active control with matching population, duration, and support?", "needed": "Direct materials with an active control, population, and duration matching the original sixteen-week question", "role": "Required", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Direct materials with an active control, population, and duration matching the original sixteen-week question", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Direct materials for a specific active healthy-diet comparison with matched population, duration, education, and attention are needed.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The current active comparisons concern type 2 diabetes at 74 weeks and NEW Soul at 12 months; their populations, durations, and controls differ from the 16-week no-change trial.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Existing active comparisons are not erased as nonexistent, but a direct comparison matching the original sixteen-week conditions is not newly confirmed.", "missingness": "Existing active comparisons are not erased as nonexistent, but a direct comparison matching the original sixteen-week conditions is not newly confirmed.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Existing active comparisons are not erased as nonexistent, but a direct comparison matching the original sixteen-week conditions is not newly confirmed." }, { "item_id": "N14", "question_type": "Comparative efficacy", "question": "Are the large no-change effect and active comparisons preserved separately?", "needed": "Effect, interval, testing, time point, and denominators for each comparison", "role": "Required", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Effect, interval, testing, time point, and denominators for each comparison", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Connect each comparison's original model, effect, interval, population, and duration separately.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The original 16-week values are retained: vegan −6.4kg versus no change −0.5kg, treatment effect −5.9kg (95% CI −6.8~−5.0), group×time P<0.001.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. These are not transferred to a mean difference or CI versus an active healthy diet. The original verdict that sixteen-week E+ was unchanged because the comparator differed is retained.", "missingness": "These are not transferred to a mean difference or CI versus an active healthy diet. The original verdict that sixteen-week E+ was unchanged because the comparator differed is retained.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "These are not transferred to a mean difference or CI versus an active healthy diet. The original verdict that sixteen-week E+ was unchanged because the comparator differed is retained." }, { "item_id": "N15", "question_type": "Comparative efficacy", "question": "Are common education, attention, and calorie conditions in the sixteen-week trial distinguished from active comparisons?", "needed": "Original group materials on education, contact, support, actual calories, and exposure", "role": "Required", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Original group materials on education, contact, support, actual calories, and exposure", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain education, attention, calories, intake, and accompanying-exposure materials for each trial separately.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The 16-week vegan group received weekly classes and support; food and supplements were not provided. Ad libitum meant no prescribed calorie restriction.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Education differences in the sixteen-week trial are not ignored or copied as identical conditions across all active comparisons. Equal actual calories or an independent mechanism is not newly asserted.", "missingness": "Education differences in the sixteen-week trial are not ignored or copied as identical conditions across all active comparisons. Equal actual calories or an independent mechanism is not newly asserted.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Education differences in the sixteen-week trial are not ignored or copied as identical conditions across all active comparisons. Equal actual calories or an independent mechanism is not newly asserted." }, { "item_id": "N16", "question_type": "Comparative efficacy", "question": "What was the original scope of open dietary allocation, masking, and measurement procedures?", "needed": "Original trial-specific materials on allocation concealment, masking, assessors, and analysts", "role": "Required", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Original trial-specific materials on allocation concealment, masking, assessors, and analysts", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain original allocation, concealment, measurement, and analysis procedures for each active-comparison trial.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The stored summary records the 16-week trial as open-label and parallel-group, with infeasible participant masking and calibrated-scale measurement.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. These details are not transferred to allocation and measurement procedures in the seventy-four-week trial or NEW Soul. The parent's B0 is historical.", "missingness": "These details are not transferred to allocation and measurement procedures in the seventy-four-week trial or NEW Soul. The parent's B0 is historical.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "These details are not transferred to allocation and measurement procedures in the seventy-four-week trial or NEW Soul. The parent's B0 is historical." }, { "item_id": "N17", "question_type": "Comparative efficacy", "question": "Are prespecified endpoint hierarchies, multiple outcomes, and testing plans separated by trial?", "needed": "Trial-specific registration, protocol, SAP, multiplicity, and change records", "role": "Required", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Trial-specific registration, protocol, SAP, multiplicity, and change records", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain each trial's original registration, protocol, SAP, change history, and outcome hierarchy.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The record quotes multiple primary outcomes including weight for the 16-week trial and primary 12-month weight for NEW Soul.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. The seventy-four-week weight hierarchy or multiplicity adjustment in active comparisons is not invented. The sixteen-week coprimary split is preserved as its original false value.", "missingness": "The seventy-four-week weight hierarchy or multiplicity adjustment in active comparisons is not invented. The sixteen-week coprimary split is preserved as its original false value.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The seventy-four-week weight hierarchy or multiplicity adjustment in active comparisons is not invented. The sixteen-week coprimary split is preserved as its original false value." }, { "item_id": "N18", "question_type": "Comparative efficacy", "question": "Are results for weight, body composition, lipids, insulin, and mechanisms separated?", "needed": "Actual measurements, effects, denominators, and prespecified plans for each measure", "role": "Required", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Actual measurements, effects, denominators, and prespecified plans for each measure", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain original measurements, effect, CI, and denominators for each measure separately.", "current_reports": [ "R01", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The original 16-week bibliography includes insulin sensitivity, metabolism, and intracellular lipids; NEW Soul's bibliography includes weight and lipids.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Original weight values are not copied as effects on other measures, body composition, or mechanisms. Those numerical results are not invented in this stored summary.", "missingness": "Original weight values are not copied as effects on other measures, body composition, or mechanisms. Those numerical results are not invented in this stored summary.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original weight values are not copied as effects on other measures, body composition, or mechanisms. Those numerical results are not invented in this stored summary." }, { "item_id": "N19", "question_type": "Comparative efficacy", "question": "Were results kept from being extended to long-term maintenance, disease, death, or diabetes treatment?", "needed": "Long-term direct materials separated by endpoint, population, and duration", "role": "Required", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Long-term direct materials separated by endpoint, population, and duration", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Connect direct follow-up, effects, and denominators for each long-term question separately.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The parent explicitly identifies long-term maintenance, clinical events, and superiority over another healthy diet as separate questions. Weight results at 74 weeks and 12 months concern those durations.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Some longer durations are not extended to benefits or null effects for all long-term maintenance, disease, death, or treatment outcomes.", "missingness": "Some longer durations are not extended to benefits or null effects for all long-term maintenance, disease, death, or treatment outcomes.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Some longer durations are not extended to benefits or null effects for all long-term maintenance, disease, death, or treatment outcomes." }, { "item_id": "N20", "question_type": "Comparative efficacy", "question": "Are shared bibliography, trials, populations, and sibling sheets preserved?", "needed": "Study-family connections among reports, original trials, the same populations, endpoints, and time points", "role": "Required", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Study-family connections among reports, original trials, the same populations, endpoints, and time points", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Connect additional reports to existing identifiers without confirming a final independent count.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The two subclaim sheets share three reports and registration identifiers. The original 16-week single-trial, R1, and mixed-independence wording belongs to parent history.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Two sheets, multiple endpoints, and long-term measurements are not added up as unique trials, total participants, or new independent replication.", "missingness": "Two sheets, multiple endpoints, and long-term measurements are not added up as unique trials, total participants, or new independent replication.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Two sheets, multiple endpoints, and long-term measurements are not added up as unique trials, total participants, or new independent replication." }, { "item_id": "N21", "question_type": "Comparative efficacy", "question": "Are PCRM, public funding, and authors who were advocacy-organization officers preserved for the sixteen-week trial?", "needed": "Records of each funder, organizational affiliation, provision, analysis, and writing role", "role": "Required", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Records of each funder, organizational affiliation, provision, analysis, and writing role", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain original support, affiliation, design, analysis, writing, and data-access disclosures separately.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "PCRM, Yale, and NIH funding and participation by PCRM clinical-research director Kahleova and president Barnard are preserved. PCRM advocates the study diet.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Public support alone is not described as confirming independence, and organizational officers are not newly classified as pharmaceutical-manufacturer employees.", "missingness": "Public support alone is not described as confirming independence, and organizational officers are not newly classified as pharmaceutical-manufacturer employees.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Public support alone is not described as confirming independence, and organizational officers are not newly classified as pharmaceutical-manufacturer employees." }, { "item_id": "N22", "question_type": "Comparative efficacy", "question": "Are gaps in support, provision, authors, and external analysis kept separate for active-comparison trials?", "needed": "Trial-specific records of monetary support, products, affiliated authors, and external analysis roles", "role": "Required", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Trial-specific records of monetary support, products, affiliated authors, and external analysis roles", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain original support, provision, affiliation, and analysis disclosures for each active-comparison trial.", "current_reports": [ "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "Funding information for the 74-week trial records NIH R01 DK059362 and other support; NEW Soul is recorded as ‘Reported trial funding’.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. No food provision and PCRM disclosures in the sixteen-week trial are not copied to other trials, and vague funding is not filled as absent or public. External analysis services also remain unverified.", "missingness": "No food provision and PCRM disclosures in the sixteen-week trial are not copied to other trials, and vague funding is not filled as absent or public. External analysis services also remain unverified.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "No food provision and PCRM disclosures in the sixteen-week trial are not copied to other trials, and vague funding is not filled as absent or public. External analysis services also remain unverified." }, { "item_id": "N23", "question_type": "Supplementary harm evidence", "question": "Are there direct comparative safety materials between active controls?", "needed": "Group harm definitions, collection, events, exposure, denominators, and plans", "role": "Required", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Group harm definitions, collection, events, exposure, denominators, and plans", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain original harm collection, group events, exposure, denominators, and discontinuation materials for each active-comparison trial.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The original materials record that the 16-week trial did not report a prespecified primary safety outcome or between-group adverse-event table.", "condition_status": "Unverified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. This non-reporting wording is not copied to all harm results in the two active-comparison trials. Detailed harm tables for the selected comparisons remain unread.", "missingness": "This non-reporting wording is not copied to all harm results in the two active-comparison trials. Detailed harm tables for the selected comparisons remain unread.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "This non-reporting wording is not copied to all harm results in the two active-comparison trials. Detailed harm tables for the selected comparisons remain unread." }, { "item_id": "N24", "question_type": "Supplementary harm evidence", "question": "Are gaps in long-term exposure, rare harms, and discontinuation retained?", "needed": "Actual exposure, discontinuation, serious events, and long-term follow-up by duration", "role": "Required", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Actual exposure, discontinuation, serious events, and long-term follow-up by duration", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Original group harm and discontinuation materials with actual exposure and sufficient duration for each diet are needed.", "current_reports": [ "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The original active-comparison durations were 74 weeks and 12 months. The parent's safety status is preserved as Caution.", "condition_status": "Unverified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Duration alone does not confirm long-term safety. Counts, rates, severity, or CIs for nutritional harms absent from the original text are not generated.", "missingness": "Duration alone does not confirm long-term safety. Counts, rates, severity, or CIs for nutritional harms absent from the original text are not generated.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Duration alone does not confirm long-term safety. Counts, rates, severity, or CIs for nutritional harms absent from the original text are not generated." }, { "item_id": "N25", "question_type": "Supplementary harm evidence", "question": "Are special populations, concomitant treatment, replication of harms, and application scope distinguished?", "needed": "Population-specific direct comparisons, harms, concomitant treatment, and independent-report relationships", "role": "Required", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Population-specific direct comparisons, harms, concomitant treatment, and independent-report relationships", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "If direct materials for those populations are provided, connect original trials, exposure, and denominators separately.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The original safety context includes pregnancy, breastfeeding, eating disorders, and people undergoing medication treatment.", "condition_status": "Unverified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. No new instructions for diet or treatment changes are created for them, and direct effects or replication of harms in those populations are not confirmed.", "missingness": "No new instructions for diet or treatment changes are created for them, and direct effects or replication of harms in those populations are not confirmed.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "No new instructions for diet or treatment changes are created for them, and direct effects or replication of harms in those populations are not confirmed." }, { "item_id": "N26", "question_type": "Comparative efficacy", "question": "Is actual access to external papers, registrations, protocols, and SAPs recorded separately?", "needed": "Original links, identifiers, stored summaries, and actual access records for each material", "role": "Required", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Original links, identifiers, stored summaries, and actual access records for each material", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Connect only materials obtained by the user, with separate type and access status.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The three PubMed URLs and NCT02939638, NCT00276939, and NCT03354377 are connected as recorded, and the summary was read for production.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. No new URL is constructed from an identifier; external abstracts, full texts, registrations, protocols, and SAPs remain unread. No separate external-link checks were performed.", "missingness": "No new URL is constructed from an identifier; external abstracts, full texts, registrations, protocols, and SAPs remain unread. No separate external-link checks were performed.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "No new URL is constructed from an identifier; external abstracts, full texts, registrations, protocols, and SAPs remain unread. No separate external-link checks were performed." }, { "item_id": "N27", "question_type": "Comparative efficacy", "question": "Are original dates, Korean and English text, corrections, axes, empty values, and subclaim D preserved?", "needed": "Separate preservation of the full parent stored summary, selected record, languages, and historical values", "role": "Required", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Separate preservation of the full parent stored summary, selected record, languages, and historical values", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Connect new materials or decisions through preservation of original text and separate events.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The reference date 2026-08-26, an empty corrections array, an empty deliberation string, Korean and English text, parent C54, Caution, original assessment axes, and subclaim D are preserved.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Absent subclaim values are not filled with the parent score. Historical cross-checking is not described as completed review here.", "missingness": "Absent subclaim values are not filled with the parent score. Historical cross-checking is not described as completed review here.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Absent subclaim values are not filled with the parent score. Historical cross-checking is not described as completed review here." }, { "item_id": "N28", "question_type": "Comparative efficacy", "question": "Are original content-review status, existing candidate history, and production completion separated?", "needed": "Records of historical candidate values and current production and review status", "role": "Supplementary", "role_reason": "An individual production condition recording original values, direct comparisons and application boundaries for the selected question", "application_exception": "Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.", "criterion": "Records of historical candidate values and current production and review status", "basis": "Superior weight loss versus another healthful diet", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Reflect only user-provided decisions and materials as separate events.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "Existing candidate pending and production-eligibility markers and boundary requirements are preserved as history, while the current marker indicates incomplete original content review. Active pending and completion flags for model, content, and boundary review are false.", "condition_status": "Partly verified", "status_reason": "Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. There is no new main claim, split, or independent certification; additional units are 0 and the final independent count is not recorded.", "missingness": "There is no new main claim, split, or independent certification; additional units are 0 and the final independent count is not recorded.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "There is no new main claim, split, or independent certification; additional units are 0 and the final independent count is not recorded." } ], "reports": [ { "report_id": "R01", "title": "Kahleova H, Petersen KF, Shulman GI, et al. Effect of a Low-Fat Vegan Diet on Body Weight, Insulin Sensitivity, Postprandial Metabolism, and Intramyocellular and Hepatocellular Lipid Levels in Overweight Adults. JAMA Netw Open. 2020;3:e2025454. PMID: 33252690.", "url": "https://pubmed.ncbi.nlm.nih.gov/33252690/", "report_type": "Trial report", "existence": "Materials preserved in original citation and evidence lists", "acquired_read": "Summary read; external materials not read", "study_family": "F01", "independent_replication": false, "observed_result": "−6.4 kg versus −0.5 kg; treatment effect −5.9 kg (95% CI −6.8~−5.0), group×time P<0.001", "result_level": "Stored review summary; not a result of directly reading the original paper or registration", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "local_summary", "public_status": "Original source link preserved", "access_status": "Summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Preserved parent verdict summary" }, { "material_type": "abstract", "public_status": "Original source link preserved", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" }, { "material_type": "fulltext", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" }, { "material_type": "registration", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" }, { "material_type": "protocol_sap", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/33252690/" } ] }, { "report_id": "R02", "title": "Barnard ND, Cohen J, Jenkins DJA, et al. A low-fat vegan diet and a conventional diabetes diet in the treatment of type 2 diabetes: a randomized, controlled, 74-wk clinical trial. Am J Clin Nutr. 2009. PMID: 19339401.", "url": "https://pubmed.ncbi.nlm.nih.gov/19339401/", "report_type": "Trial report", "existence": "Materials preserved in original citation and evidence lists", "acquired_read": "Summary read; external materials not read", "study_family": "F02", "independent_replication": false, "observed_result": "−4.4 kg versus −3.0 kg, between-group P=0.25", "result_level": "Stored review summary; not a result of directly reading the original paper or registration", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "local_summary", "public_status": "Original source link preserved", "access_status": "Summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Preserved parent verdict summary" }, { "material_type": "abstract", "public_status": "Original source link preserved", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" }, { "material_type": "fulltext", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" }, { "material_type": "registration", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" }, { "material_type": "protocol_sap", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/19339401/" } ] }, { "report_id": "R03", "title": "Effect of a Plant-Based vs Omnivorous Soul Food Diet on Weight and Lipid Levels Among African Americans. PMID: 36633848. NCT03354377.", "url": "https://pubmed.ncbi.nlm.nih.gov/36633848/", "report_type": "Trial report", "existence": "Materials preserved in original citation and evidence lists", "acquired_read": "Summary read; external materials not read", "study_family": "F03", "independent_replication": false, "observed_result": "−2.39 kg versus −2.03 kg, between-group P=.64", "result_level": "Stored review summary; not a result of directly reading the original paper or registration", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "local_summary", "public_status": "Original source link preserved", "access_status": "Summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Preserved parent verdict summary" }, { "material_type": "abstract", "public_status": "Original source link preserved", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" }, { "material_type": "fulltext", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" }, { "material_type": "registration", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" }, { "material_type": "protocol_sap", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/36633848/" } ] } ], "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 methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed." }, { "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 methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed." }, { "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 methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed." }, { "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 methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed." }, { "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 methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed." } ], "status_dictionary": { "Partly verified": "Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.", "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety", "Review incomplete": "Review of existing content incomplete", "Met": "Use only within the relevant conditions after existing content review; no automatic designation in this preparation", "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings", "Inaccessible": "Not applied during this preparation because actual access was not tested", "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary", "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation", "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials" }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "NCT02939638 is a sixteen-week no-change-control trial whose report is shared by two subclaims. NCT00276939 is a seventy-four-week active diabetes-diet comparison in a different population and duration. NCT03354377 NEW Soul is a twelve-month active comparison whose report is shared by two subclaims. Report relationships do not certify a unique-trial count; reports, subclaims, and participants are not newly added up as independent materials." }, "history": [ { "date": "2026-10-11", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public reader pages and material were prepared from the existing 28 items. No new clinical searches, verification-state changes or scoring were performed." } ], "language": "en", "translation_date": "2026-10-11" }