{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2946-s0", "verdict_number": "2946", "title": "Ad libitum low-fat vegan composite diet × Sixteen-week weight loss versus no diet change — 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": "Direct no-diet-change control; the other two active healthy-diet comparisons concern different populations and durations", "endpoint": "Selected sixteen-week weight change; other metabolic outcomes, body composition, and clinical events are separated", "duration": "Selected sixteen weeks; the other seventy-four-week and twelve-month comparisons are preserved separately", "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 sixteen-week comparison and subclaim grade distinguished from the parent context?", "needed": "Separate records of the selected wording, grade, note, and parent verdict", "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 verdict", "basis": "Sixteen-week weight loss versus no diet change", "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, connect the selected question and the parent's application boundaries separately.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The selected existing claim is ‘16-week weight loss versus no diet change’, with original subclaim grade C and a note of treatment effect −5.9 kg. The parent verdict is C, 54 points, 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. Subclaim score, status, and axes are absent and are not filled with parent values. No new verdict was made.", "missingness": "Subclaim score, status, and axes are absent and are not filled with parent values. No new verdict was made.", "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": "Subclaim score, status, and axes are absent and are not filled with parent values. No new verdict was made." }, { "item_id": "N02", "question_type": "Comparative efficacy", "question": "Who were the overweight adults in the trial, and what were their baseline characteristics?", "needed": "Eligibility, age, BMI, comorbidities, baseline weight, and group 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": "Eligibility, age, BMI, comorbidities, baseline weight, and group denominators", "basis": "Sixteen-week weight loss versus no diet change", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain the original trial's eligibility criteria, baseline characteristics table, and denominators.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The original effect concerns overweight adults in a randomized trial of 244 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. Eligible age and BMI ranges, comorbidities, and detailed baseline weight are absent from the stored summary. The trial in people with type 2 diabetes is not treated as the same population.", "missingness": "Eligible age and BMI ranges, comorbidities, and detailed baseline weight are absent from the stored summary. The trial in people with type 2 diabetes is not treated as the same population.", "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": "Eligible age and BMI ranges, comorbidities, and detailed baseline weight are absent from the stored summary. The trial in people with type 2 diabetes is not treated as the same population." }, { "item_id": "N03", "question_type": "Comparative efficacy", "question": "What was the ad libitum low-fat vegan composite diet?", "needed": "Study records of diet composition, education, support, actual intake, 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": "Study records of diet composition, education, support, actual intake, and exposure", "basis": "Sixteen-week weight loss versus no diet change", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Connect original materials on diet composition, education, actual intake, and adherence.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The original intervention was an ad libitum low-fat vegan diet. The historical study conditions included education to avoid animal products and added fats and to lower fat intake.", "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 comparison did not isolate the effects of individual foods, fat restriction, or excluding animal products. No dietary instructions for readers are created.", "missingness": "The comparison did not isolate the effects of individual foods, fat restriction, or excluding animal products. No dietary instructions for readers 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": "The comparison did not isolate the effects of individual foods, fat restriction, or excluding animal products. No dietary instructions for readers are created." }, { "item_id": "N04", "question_type": "Comparative efficacy", "question": "Are food and supplement provision distinguished from classes and support?", "needed": "Original group records of food provision, supplements, contact, classes, and support", "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 records of food provision, supplements, contact, classes, and support", "basis": "Sixteen-week weight loss versus no diet change", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain group records of classes, support, contact, participation, and exposure to food or supplements.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The record states that food and supplements were not provided, while the vegan group received weekly classes and support.", "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 does not establish that education, attention, and contact were matched between groups. Actual class participation and detailed control-group contact remain unread.", "missingness": "No food provision does not establish that education, attention, and contact were matched between groups. Actual class participation and detailed control-group contact 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 food provision does not establish that education, attention, and contact were matched between groups. Actual class participation and detailed control-group contact remain unread." }, { "item_id": "N05", "question_type": "Comparative efficacy", "question": "Are a no-change control and other healthy-diet controls different comparisons?", "needed": "Original records of actual control diet, management, and additional 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 actual control diet, management, and additional treatment", "basis": "Sixteen-week weight loss versus no diet change", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Connect the original control's actual exposure and direct comparisons with other healthy diets separately.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The direct comparison was with a control group that did not change its diet. The stored summary explicitly states that this was not a trial against another healthy 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. This effect is not transferred to superiority over all healthy diets. Detailed actual control-group intake and accompanying management remain unread.", "missingness": "This effect is not transferred to superiority over all healthy diets. Detailed actual control-group intake and accompanying management 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 effect is not transferred to superiority over all healthy diets. Detailed actual control-group intake and accompanying management remain unread." }, { "item_id": "N06", "question_type": "Comparative efficacy", "question": "Does ad libitum establish matched actual calories or intake?", "needed": "Distinction between prescribed calories, actual intake, energy differences, and study 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": "Distinction between prescribed calories, actual intake, energy differences, and study exposure", "basis": "Sixteen-week weight loss versus no diet change", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Connect actual intake, exposure, energy measurements, and prespecified analysis materials when provided.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The stored summary explains that ‘eating freely’ 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. No new mechanistic conclusion is made that actual calories, education, and attention were equal between groups or that the effect was independent of calories.", "missingness": "No new mechanistic conclusion is made that actual calories, education, and attention were equal between groups or that the effect was independent of calories.", "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 mechanistic conclusion is made that actual calories, education, and attention were equal between groups or that the effect was independent of calories." }, { "item_id": "N07", "question_type": "Comparative efficacy", "question": "What were the units, methods, and timing of sixteen-week weight measurement?", "needed": "Baseline and sixteen-week measurements, calibrated scale, units, and procedures", "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": "Baseline and sixteen-week measurements, calibrated scale, units, and procedures", "basis": "Sixteen-week weight loss versus no diet change", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain original measurement procedures, group labels, and values at each time point.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The endpoint was 16-week weight change. The existing review summary quotes measurement using a calibrated scale accurate to 0.1kg.", "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. Measurement protocol, clothing, assessors, repeated-measure handling, and distributions remain unread. No new weight calculation is performed.", "missingness": "Measurement protocol, clothing, assessors, repeated-measure handling, and distributions remain unread. No new weight calculation is 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": "Measurement protocol, clothing, assessors, repeated-measure handling, and distributions remain unread. No new weight calculation is performed." }, { "item_id": "N08", "question_type": "Comparative efficacy", "question": "Are within-group weight changes and the between-group treatment effect preserved as recorded?", "needed": "Original materials for group changes, treatment 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": "Original materials for group changes, treatment effect, CI, and testing", "basis": "Sixteen-week weight loss versus no diet change", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Connect the original between-group model, effect, interval, denominators, and group tables.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The vegan group changed by −6.4 kg and the no-change control by −0.5 kg; treatment effect −5.9 kg (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. No new difference, ratio, number of participants losing weight, or NNT is calculated. Individual responses, variance, and model details remain unread.", "missingness": "No new difference, ratio, number of participants losing weight, or NNT is calculated. Individual responses, variance, and model 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": "No new difference, ratio, number of participants losing weight, or NNT is calculated. Individual responses, variance, and model details remain unread." }, { "item_id": "N09", "question_type": "Comparative efficacy", "question": "Are randomization, completion, and analysis populations distinguished?", "needed": "Allocation, completion, ITT, missing data, and group 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": "Allocation, completion, ITT, missing data, and group analysis denominators", "basis": "Sixteen-week weight loss versus no diet change", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain group follow-up flow, analysis populations, reasons for missing data, and endpoint-specific denominators.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "Of 244 randomized participants (122/122), 222 (91.0%) completed the 16-week assessment. The main analysis used a repeated-measures model incorporating missing data.", "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 222 completers are not newly divided by group, and dropout rates or counts are not calculated. Equal denominators for all endpoints are not confirmed.", "missingness": "The 222 completers are not newly divided by group, and dropout rates or counts are not calculated. Equal denominators for all endpoints 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": "The 222 completers are not newly divided by group, and dropout rates or counts are not calculated. Equal denominators for all endpoints are not confirmed." }, { "item_id": "N10", "question_type": "Comparative efficacy", "question": "Are the limitations of ITT and a repeated-measures model incorporating missing data recorded?", "needed": "Prespecified original plans for model, missing-data assumptions, variables, sensitivity, and exclusions", "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": "Prespecified original plans for model, missing-data assumptions, variables, sensitivity, and exclusions", "basis": "Sixteen-week weight loss versus no diet change", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain the original SAP and materials on missing-data handling, group attrition, and sensitivity analyses.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The existing review summary quotes an ITT analysis including all participants and missing data incorporated in a repeated-measures model.", "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 does not certify that missing outcomes were actually observed or that all missing-data bias was resolved. Model assumptions, sensitivity analyses, and reasons for missing data remain unread.", "missingness": "This does not certify that missing outcomes were actually observed or that all missing-data bias was resolved. Model assumptions, sensitivity analyses, and reasons for missing data 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 does not certify that missing outcomes were actually observed or that all missing-data bias was resolved. Model assumptions, sensitivity analyses, and reasons for missing data remain unread." }, { "item_id": "N11", "question_type": "Comparative efficacy", "question": "What information is available about allocation, participant masking, and measurement procedures?", "needed": "Original methods for allocation, concealment, and assessor and analyst masking", "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 methods for allocation, concealment, and assessor and analyst masking", "basis": "Sixteen-week weight loss versus no diet change", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain original allocation, concealment, assessor, and analyst procedures and methods.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The existing review summary records wording about 1:1 randomization and infeasibility of masking diet participants, and describes 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. The 1:1 allocation wording is not converted into additional verification of actual concealment procedures. The parent B0 axis is historical and is not reassessed here.", "missingness": "The 1:1 allocation wording is not converted into additional verification of actual concealment procedures. The parent B0 axis is historical and is not reassessed 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": "The 1:1 allocation wording is not converted into additional verification of actual concealment procedures. The parent B0 axis is historical and is not reassessed here." }, { "item_id": "N12", "question_type": "Comparative efficacy", "question": "Are multiple primary outcomes distinguished from the prespecified hierarchy of the weight question?", "needed": "Original records of registration, protocol, SAP, multiplicity, and effect of interest", "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 registration, protocol, SAP, multiplicity, and effect of interest", "basis": "Sixteen-week weight loss versus no diet change", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Connect outcome hierarchy, testing, and change histories in the registration, protocol, and SAP.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The quoted original primary outcomes were body weight, insulin resistance, postprandial metabolism, and intramyocellular and hepatocellular lipid levels. The record states consistency with NCT02939638.", "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. Weight is not newly designated the sole primary outcome, and multiplicity adjustment is not invented. The parent's coprimary split is preserved as false.", "missingness": "Weight is not newly designated the sole primary outcome, and multiplicity adjustment is not invented. The parent's coprimary split is preserved as false.", "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": "Weight is not newly designated the sole primary outcome, and multiplicity adjustment is not invented. The parent's coprimary split is preserved as false." }, { "item_id": "N13", "question_type": "Comparative efficacy", "question": "Is a large kilogram difference distinguished from a verified clinical-importance threshold?", "needed": "Prespecified minimum clinically important weight-loss threshold and original plan for the selected 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": "Prespecified minimum clinically important weight-loss threshold and original plan for the selected population and duration", "basis": "Sixteen-week weight loss versus no diet change", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Connect prespecified importance, meaningful response, and population-specific application plans when provided.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The stored summary rates the −5.9kg effect as large but records that no minimum clinically important weight-loss threshold was declared in advance.", "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 threshold, universal weight-loss target, or exclusion of all clinical benefits is created. The original CI is retained.", "missingness": "No new threshold, universal weight-loss target, or exclusion of all clinical benefits is created. The original CI 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": "No new threshold, universal weight-loss target, or exclusion of all clinical benefits is created. The original CI is retained." }, { "item_id": "N14", "question_type": "Comparative efficacy", "question": "Are weight, other surrogate outcomes, body composition, and mechanisms supported separately?", "needed": "Endpoint-specific materials for weight, insulin, postprandial metabolism, body composition, and intracellular lipids", "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": "Endpoint-specific materials for weight, insulin, postprandial metabolism, body composition, and intracellular lipids", "basis": "Sixteen-week weight loss versus no diet change", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain each endpoint's definition, measurement, denominators, effect, CI, and prespecified plan separately.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "Insulin sensitivity, metabolism, and intracellular lipids appear in the original bibliography and quoted multiple primary outcomes.", "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. Their numerical results are absent from this summary, so the weight effect is not copied as their result. Mechanisms do not replace the direct weight comparison.", "missingness": "Their numerical results are absent from this summary, so the weight effect is not copied as their result. Mechanisms do not replace the direct weight comparison.", "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": "Their numerical results are absent from this summary, so the weight effect is not copied as their result. Mechanisms do not replace the direct weight comparison." }, { "item_id": "N15", "question_type": "Comparative efficacy", "question": "Was the sixteen-week result extended to long-term maintenance, disease, or death?", "needed": "Direct follow-up, denominators, and effects for long-term weight and clinical events", "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 follow-up, denominators, and effects for long-term weight and clinical events", "basis": "Sixteen-week weight loss versus no diet change", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Connect separate long-term direct comparisons and clinical-event materials for the relevant population.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The parent describes weight as a surrogate for clinical events and records long-term maintenance, cardiovascular disease prevention, and diabetes treatment as separate questions.", "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 sixteen-week reduction is not converted into long-term maintenance, prevention of disease or death, or a treatment effect.", "missingness": "The sixteen-week reduction is not converted into long-term maintenance, prevention of disease or death, or a treatment effect.", "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 sixteen-week reduction is not converted into long-term maintenance, prevention of disease or death, or a treatment effect." }, { "item_id": "N16", "question_type": "Comparative efficacy", "question": "Is the seventy-four-week diabetes-diet comparison the same as a sixteen-week no-change comparison?", "needed": "Direct comparisons and original denominators separated by population, comparator, 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": "Direct comparisons and original denominators separated by population, comparator, and duration", "basis": "Sixteen-week weight loss versus no diet change", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Connect each trial's population, diet composition, denominators, effect, and CI separately.", "current_reports": [ "R02" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "A randomized trial in 99 participants with type 2 diabetes recorded 74-week changes of −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. Results in a different population, with an active comparator and different duration, are not merged into a new sixteen-week no-change effect or certification of replication.", "missingness": "Results in a different population, with an active comparator and different duration, are not merged into a new sixteen-week no-change effect or certification of 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": "Results in a different population, with an active comparator and different duration, are not merged into a new sixteen-week no-change effect or certification of replication." }, { "item_id": "N17", "question_type": "Comparative efficacy", "question": "Does the NEW Soul active-control result concern a different population and duration?", "needed": "Original NEW Soul materials on population, the two diets, endpoints, 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": "Original NEW Soul materials on population, the two diets, endpoints, and denominators", "basis": "Sixteen-week weight loss versus no diet change", "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 population, comparator composition, denominators, hierarchy, and CI.", "current_reports": [ "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "NEW Soul randomized 159 participants. Its 12-month primary weight result for vegan versus low-fat omnivorous soul food was −2.39kg versus −2.03kg, P=.64. The bibliography specifies African Americans.", "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 a sixteen-week no-change comparison in the same population. Detailed recruitment criteria, group denominators, and CI remain unread.", "missingness": "This is not transferred to a sixteen-week no-change comparison in the same population. Detailed recruitment criteria, group denominators, and CI 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 a sixteen-week no-change comparison in the same population. Detailed recruitment criteria, group denominators, and CI remain unread." }, { "item_id": "N18", "question_type": "Comparative efficacy", "question": "Are null active-comparison results kept separate from the original sixteen-week E+ and R1?", "needed": "Relationships between results with matching populations, comparisons, 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": "Relationships between results with matching populations, comparisons, and time points", "basis": "Sixteen-week weight loss versus no diet change", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Connect each comparison question's plan, CI, importance, and application scope separately.", "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 that the active comparisons involve different populations and do not change the 16-week E+ and R1 versus 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. P=0.25 and .64 do not certify zero effect for all vegan diets or equivalence with all healthy diets.", "missingness": "P=0.25 and .64 do not certify zero effect for all vegan diets or equivalence with all healthy diets.", "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": "P=0.25 and .64 do not certify zero effect for all vegan diets or equivalence with all healthy diets." }, { "item_id": "N19", "question_type": "Comparative efficacy", "question": "Were shared reports, sibling questions, and the same participants kept from being counted as independent replication?", "needed": "Study-family connections among original bibliography, trials, participants, and endpoints", "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 original bibliography, trials, participants, and endpoints", "basis": "Sixteen-week weight loss versus no diet change", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Connect additional reports through original trial identifiers while retaining same-population relationships.", "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 bibliographic records and the parent stored summary. NCT02939638, NCT00276939, and NCT03354377 are preserved report by report.", "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. Reports, tables, multiple endpoints, and repeated measurements are not added up as unique trials or total participants. The final independent count is not recorded.", "missingness": "Reports, tables, multiple endpoints, and repeated measurements are not added up as unique trials or total participants. 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": "Reports, tables, multiple endpoints, and repeated measurements are not added up as unique trials or total participants. The final independent count is not recorded." }, { "item_id": "N20", "question_type": "Comparative efficacy", "question": "Are PCRM, public grants, and organizational author roles distinguished?", "needed": "Separate records of support, organizational roles, affiliations, design, analysis, and writing", "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 support, organizational roles, affiliations, design, analysis, and writing", "basis": "Sixteen-week weight loss versus no diet change", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain original funding, affiliations, study roles, data-access, and analysis disclosures separately.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "Recorded funding includes PCRM, Yale Diabetes Center P30 DK-045735, R01 DK-113984, NIH P30 DK034989, and UL1 TR001863. Kahleova is recorded as PCRM's director of clinical research and Barnard as its president; 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. Mixed support is not labeled as public funding alone. Organizational officers are not newly classified as pharmaceutical-manufacturer employees.", "missingness": "Mixed support is not labeled as public funding alone. 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": "Mixed support is not labeled as public funding alone. Organizational officers are not newly classified as pharmaceutical-manufacturer employees." }, { "item_id": "N21", "question_type": "Comparative efficacy", "question": "Are no food provision and gaps in other interests or external analysis roles distinguished?", "needed": "Separate materials on product provision, monetary support, affiliated authors, and external analysis services", "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 materials on product provision, monetary support, affiliated authors, and external analysis services", "basis": "Sixteen-week weight loss versus no diet change", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Connect original disclosures of sponsorship, products, affiliations, and external analysis and writing roles.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "No provision of food or supplements is preserved alongside PCRM funding and participation by authors who were organizational officers.", "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 provision is not converted into absence of all interests. Detailed roles of external analysis services and sponsors in design and manuscript preparation remain unread.", "missingness": "No provision is not converted into absence of all interests. Detailed roles of external analysis services and sponsors in design and manuscript preparation 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 provision is not converted into absence of all interests. Detailed roles of external analysis services and sponsors in design and manuscript preparation remain unread." }, { "item_id": "N22", "question_type": "Comparative efficacy", "question": "Is the level of funding information preserved separately for the other two active-comparison trials?", "needed": "Original support, provision, affiliations, and analysis roles for each 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": "Original support, provision, affiliations, and analysis roles for each trial", "basis": "Sixteen-week weight loss versus no diet change", "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 support, affiliation, provision, and analysis disclosures separately.", "current_reports": [ "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The 74-week trial records NIH R01 DK059362 and other funding; NEW Soul's original wording is ‘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. The vague NEW Soul funding wording is not filled with a specific funder, no support, or confirmed independence.", "missingness": "The vague NEW Soul funding wording is not filled with a specific funder, no support, or confirmed independence.", "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 vague NEW Soul funding wording is not filled with a specific funder, no support, or confirmed independence." }, { "item_id": "N23", "question_type": "Supplementary harm evidence", "question": "Are prespecified safety outcomes, adverse-event comparisons, and unread materials distinguished?", "needed": "Harm collection, group events, exposure, denominators, and prespecified 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": "Harm collection, group events, exposure, denominators, and prespecified plans", "basis": "Sixteen-week weight loss versus no diet change", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain original harm-collection methods, group events, exposure, discontinuations, and denominators.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The existing review summary records that no prespecified primary safety outcome or between-group adverse-event table was reported. The parent's safety status is 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. This original non-reporting wording is limited to the preserved review summary; the entire external full text was not checked here. It is not converted into zero events or safety.", "missingness": "This original non-reporting wording is limited to the preserved review summary; the entire external full text was not checked here. It is not converted into zero events or safety.", "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 original non-reporting wording is limited to the preserved review summary; the entire external full text was not checked here. It is not converted into zero events or safety." }, { "item_id": "N24", "question_type": "Supplementary harm evidence", "question": "Are gaps in short-term and long-term nutritional harms and rare events preserved?", "needed": "Actual dietary exposure, discontinuation, group harms, and long-term follow-up", "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 dietary exposure, discontinuation, group harms, and long-term follow-up", "basis": "Sixteen-week weight loss versus no diet change", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Direct materials on actual exposure, discontinuation, nutrition-related measurements, rare harms, and long-term follow-up are needed.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The original safety record describes comparative materials as limited.", "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. Specific counts, severity, or long-term incidence of nutritional harms absent from the original text are not invented. Benefit alone does not certify safety.", "missingness": "Specific counts, severity, or long-term incidence of nutritional harms absent from the original text are not invented. Benefit alone does not certify safety.", "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": "Specific counts, severity, or long-term incidence of nutritional harms absent from the original text are not invented. Benefit alone does not certify safety." }, { "item_id": "N25", "question_type": "Supplementary harm evidence", "question": "Was new certainty avoided for application to special populations, concomitant treatment, and replication of harms?", "needed": "Population-specific direct comparisons, exposure, harms, and follow-up materials", "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, exposure, harms, and follow-up materials", "basis": "Sixteen-week weight loss versus no diet change", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "If direct materials and trial–harm relationships for those populations 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 parent's existing safety explanation includes contexts of pregnancy, breastfeeding, eating disorders, and ongoing 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. Effects and harms in those populations are not presented as verified in this trial or turned into instructions for changing diet, medication, or clinical care.", "missingness": "Effects and harms in those populations are not presented as verified in this trial or turned into instructions for changing diet, medication, or clinical care.", "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": "Effects and harms in those populations are not presented as verified in this trial or turned into instructions for changing diet, medication, or clinical care." }, { "item_id": "N26", "question_type": "Comparative efficacy", "question": "Are external links and registration identifiers separated from actual access status?", "needed": "Separate access records for summaries, abstracts, full texts, registrations, protocols, and SAPs", "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 access records for summaries, abstracts, full texts, registrations, protocols, and SAPs", "basis": "Sixteen-week weight loss versus no diet change", "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 access status for each.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The entire parent stored summary was read for production, and the three original PubMed source links and registration identifiers were connected as 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. No new URL is built from a registration identifier, and a URL's existence is not labeled as full-text reading or completed review. All external materials remain unread.", "missingness": "No new URL is built from a registration identifier, and a URL's existence is not labeled as full-text reading or completed review. All external materials 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 URL is built from a registration identifier, and a URL's existence is not labeled as full-text reading or completed review. All external materials remain unread." }, { "item_id": "N27", "question_type": "Comparative efficacy", "question": "Are the reference date, Korean and English text, original axes, corrections, and empty values preserved?", "needed": "Separate records of the full original text and subclaim and parent histories", "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 full original text and subclaim and parent histories", "basis": "Sixteen-week weight loss versus no diet change", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Proposal: Link new materials or decisions to separate change events while preserving original text.", "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, C54, Caution, and the original assessment axes 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. Unrecorded precision and the false coprimary split value are not filled with a new verdict. This production date is not a new clinical verification date.", "missingness": "Unrecorded precision and the false coprimary split value are not filled with a new verdict. This production date is not a new clinical verification date.", "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": "Unrecorded precision and the false coprimary split value are not filled with a new verdict. This production date is not a new clinical verification date." }, { "item_id": "N28", "question_type": "Comparative efficacy", "question": "Are production status, original content review, and independent certification distinguished?", "needed": "Separate records of existing candidate history, 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": "Separate records of existing candidate history, production, and review status", "basis": "Sixteen-week weight loss versus no diet change", "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": "The current marker indicates incomplete original content review; active pending and completion flags for model, content, and boundary review are false. Existing candidate pending and production-eligibility markers and boundary requirements are preserved as 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. There is no new main claim, split, or independent certification; new units are 0 and the final independent count is not recorded.", "missingness": "There is no new main claim, split, or independent certification; new 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; new 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. 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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" }