# Ad libitum low-fat vegan composite diet × Sixteen-week weight loss versus no diet change — Evidence checklist Verdict 2946 · Evidence Check Stored-material review date: Not recorded Original evidence cut-off: 2026-08-26 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-11 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - Population: 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 - Ingredient, formulation and route: 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 - Measured outcome: 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 - Questions outside this scope: 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 ## Checklist items ### N01 · Are the selected sixteen-week comparison and subclaim grade distinguished from the parent context? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: Subclaim score, status, and axes are absent and are not filled with parent values. No new verdict was made. - Required materials and conditions: Separate records of the selected wording, grade, note, and parent verdict - Materials to obtain first: Subclaim score, status, and axes are absent and are not filled with parent values. No new verdict was made. - Further research: If additional materials are provided, connect the selected question and the parent's application boundaries separately. - Conditions for verification: Separate records of the selected wording, grade, note, and parent verdict - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R01 ### N02 · Who were the overweight adults in the trial, and what were their baseline characteristics? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original effect concerns overweight adults in a randomized trial of 244 participants. - Why unverified: 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. - Reason for missing information: 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. - Required materials and conditions: Eligibility, age, BMI, comorbidities, baseline weight, and group denominators - Materials to obtain first: 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. - Further research: Obtain the original trial's eligibility criteria, baseline characteristics table, and denominators. - Conditions for verification: Eligibility, age, BMI, comorbidities, baseline weight, and group denominators - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R01 ### N03 · What was the ad libitum low-fat vegan composite diet? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: The comparison did not isolate the effects of individual foods, fat restriction, or excluding animal products. No dietary instructions for readers are created. - Required materials and conditions: Study records of diet composition, education, support, actual intake, and exposure - Materials to obtain first: The comparison did not isolate the effects of individual foods, fat restriction, or excluding animal products. No dietary instructions for readers are created. - Further research: Connect original materials on diet composition, education, actual intake, and adherence. - Conditions for verification: Study records of diet composition, education, support, actual intake, and exposure - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R01 ### N04 · Are food and supplement provision distinguished from classes and support? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The record states that food and supplements were not provided, while the vegan group received weekly classes and support. - Why unverified: 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. - Reason for missing information: 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. - Required materials and conditions: Original group records of food provision, supplements, contact, classes, and support - Materials to obtain first: 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. - Further research: Obtain group records of classes, support, contact, participation, and exposure to food or supplements. - Conditions for verification: Original group records of food provision, supplements, contact, classes, and support - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R01 ### N05 · Are a no-change control and other healthy-diet controls different comparisons? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: This effect is not transferred to superiority over all healthy diets. Detailed actual control-group intake and accompanying management remain unread. - Required materials and conditions: Original records of actual control diet, management, and additional treatment - Materials to obtain first: This effect is not transferred to superiority over all healthy diets. Detailed actual control-group intake and accompanying management remain unread. - Further research: Connect the original control's actual exposure and direct comparisons with other healthy diets separately. - Conditions for verification: Original records of actual control diet, management, and additional treatment - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R01 ### N06 · Does ad libitum establish matched actual calories or intake? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The stored summary explains that ‘eating freely’ meant no prescribed calorie restriction. - Why unverified: 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. - Reason for missing information: No new mechanistic conclusion is made that actual calories, education, and attention were equal between groups or that the effect was independent of calories. - Required materials and conditions: Distinction between prescribed calories, actual intake, energy differences, and study exposure - Materials to obtain first: No new mechanistic conclusion is made that actual calories, education, and attention were equal between groups or that the effect was independent of calories. - Further research: Connect actual intake, exposure, energy measurements, and prespecified analysis materials when provided. - Conditions for verification: Distinction between prescribed calories, actual intake, energy differences, and study exposure - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R01 ### N07 · What were the units, methods, and timing of sixteen-week weight measurement? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The endpoint was 16-week weight change. The existing review summary quotes measurement using a calibrated scale accurate to 0.1kg. - Why unverified: 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. - Reason for missing information: Measurement protocol, clothing, assessors, repeated-measure handling, and distributions remain unread. No new weight calculation is performed. - Required materials and conditions: Baseline and sixteen-week measurements, calibrated scale, units, and procedures - Materials to obtain first: Measurement protocol, clothing, assessors, repeated-measure handling, and distributions remain unread. No new weight calculation is performed. - Further research: Obtain original measurement procedures, group labels, and values at each time point. - Conditions for verification: Baseline and sixteen-week measurements, calibrated scale, units, and procedures - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R01 ### N08 · Are within-group weight changes and the between-group treatment effect preserved as recorded? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: No new difference, ratio, number of participants losing weight, or NNT is calculated. Individual responses, variance, and model details remain unread. - Required materials and conditions: Original materials for group changes, treatment effect, CI, and testing - Materials to obtain first: No new difference, ratio, number of participants losing weight, or NNT is calculated. Individual responses, variance, and model details remain unread. - Further research: Connect the original between-group model, effect, interval, denominators, and group tables. - Conditions for verification: Original materials for group changes, treatment effect, CI, and testing - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R01 ### N09 · Are randomization, completion, and analysis populations distinguished? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: 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. - Required materials and conditions: Allocation, completion, ITT, missing data, and group analysis denominators - Materials to obtain first: 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. - Further research: Obtain group follow-up flow, analysis populations, reasons for missing data, and endpoint-specific denominators. - Conditions for verification: Allocation, completion, ITT, missing data, and group analysis denominators - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R01 ### N10 · Are the limitations of ITT and a repeated-measures model incorporating missing data recorded? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The existing review summary quotes an ITT analysis including all participants and missing data incorporated in a repeated-measures model. - Why unverified: 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. - Reason for missing information: 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. - Required materials and conditions: Prespecified original plans for model, missing-data assumptions, variables, sensitivity, and exclusions - Materials to obtain first: 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. - Further research: Obtain the original SAP and materials on missing-data handling, group attrition, and sensitivity analyses. - Conditions for verification: Prespecified original plans for model, missing-data assumptions, variables, sensitivity, and exclusions - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R01 ### N11 · What information is available about allocation, participant masking, and measurement procedures? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The existing review summary records wording about 1:1 randomization and infeasibility of masking diet participants, and describes calibrated-scale measurement. - Why unverified: 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. - Reason for missing information: 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. - Required materials and conditions: Original methods for allocation, concealment, and assessor and analyst masking - Materials to obtain first: 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. - Further research: Obtain original allocation, concealment, assessor, and analyst procedures and methods. - Conditions for verification: Original methods for allocation, concealment, and assessor and analyst masking - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R01 ### N12 · Are multiple primary outcomes distinguished from the prespecified hierarchy of the weight question? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The quoted original primary outcomes were body weight, insulin resistance, postprandial metabolism, and intramyocellular and hepatocellular lipid levels. The record states consistency with NCT02939638. - Why unverified: 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. - Reason for missing information: Weight is not newly designated the sole primary outcome, and multiplicity adjustment is not invented. The parent's coprimary split is preserved as false. - Required materials and conditions: Original records of registration, protocol, SAP, multiplicity, and effect of interest - Materials to obtain first: Weight is not newly designated the sole primary outcome, and multiplicity adjustment is not invented. The parent's coprimary split is preserved as false. - Further research: Connect outcome hierarchy, testing, and change histories in the registration, protocol, and SAP. - Conditions for verification: Original records of registration, protocol, SAP, multiplicity, and effect of interest - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R01 ### N13 · Is a large kilogram difference distinguished from a verified clinical-importance threshold? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The stored summary rates the −5.9kg effect as large but records that no minimum clinically important weight-loss threshold was declared in advance. - Why unverified: 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. - Reason for missing information: No new threshold, universal weight-loss target, or exclusion of all clinical benefits is created. The original CI is retained. - Required materials and conditions: Prespecified minimum clinically important weight-loss threshold and original plan for the selected population and duration - Materials to obtain first: No new threshold, universal weight-loss target, or exclusion of all clinical benefits is created. The original CI is retained. - Further research: Connect prespecified importance, meaningful response, and population-specific application plans when provided. - Conditions for verification: Prespecified minimum clinically important weight-loss threshold and original plan for the selected population and duration - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R01 ### N14 · Are weight, other surrogate outcomes, body composition, and mechanisms supported separately? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Insulin sensitivity, metabolism, and intracellular lipids appear in the original bibliography and quoted multiple primary outcomes. - Why unverified: 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. - Reason for missing information: 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. - Required materials and conditions: Endpoint-specific materials for weight, insulin, postprandial metabolism, body composition, and intracellular lipids - Materials to obtain first: 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. - Further research: Obtain each endpoint's definition, measurement, denominators, effect, CI, and prespecified plan separately. - Conditions for verification: Endpoint-specific materials for weight, insulin, postprandial metabolism, body composition, and intracellular lipids - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R01 ### N15 · Was the sixteen-week result extended to long-term maintenance, disease, or death? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The parent describes weight as a surrogate for clinical events and records long-term maintenance, cardiovascular disease prevention, and diabetes treatment as separate questions. - Why unverified: 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. - Reason for missing information: The sixteen-week reduction is not converted into long-term maintenance, prevention of disease or death, or a treatment effect. - Required materials and conditions: Direct follow-up, denominators, and effects for long-term weight and clinical events - Materials to obtain first: The sixteen-week reduction is not converted into long-term maintenance, prevention of disease or death, or a treatment effect. - Further research: Connect separate long-term direct comparisons and clinical-event materials for the relevant population. - Conditions for verification: Direct follow-up, denominators, and effects for long-term weight and clinical events - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R01 ### N16 · Is the seventy-four-week diabetes-diet comparison the same as a sixteen-week no-change comparison? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: 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. - Required materials and conditions: Direct comparisons and original denominators separated by population, comparator, and duration - Materials to obtain first: 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. - Further research: Connect each trial's population, diet composition, denominators, effect, and CI separately. - Conditions for verification: Direct comparisons and original denominators separated by population, comparator, and duration - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R02 ### N17 · Does the NEW Soul active-control result concern a different population and duration? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: This is not transferred to a sixteen-week no-change comparison in the same population. Detailed recruitment criteria, group denominators, and CI remain unread. - Required materials and conditions: Original NEW Soul materials on population, the two diets, endpoints, and denominators - Materials to obtain first: This is not transferred to a sixteen-week no-change comparison in the same population. Detailed recruitment criteria, group denominators, and CI remain unread. - Further research: Obtain NEW Soul's original population, comparator composition, denominators, hierarchy, and CI. - Conditions for verification: Original NEW Soul materials on population, the two diets, endpoints, and denominators - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R03 ### N18 · Are null active-comparison results kept separate from the original sixteen-week E+ and R1? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: P=0.25 and .64 do not certify zero effect for all vegan diets or equivalence with all healthy diets. - Required materials and conditions: Relationships between results with matching populations, comparisons, and time points - Materials to obtain first: P=0.25 and .64 do not certify zero effect for all vegan diets or equivalence with all healthy diets. - Further research: Connect each comparison question's plan, CI, importance, and application scope separately. - Conditions for verification: Relationships between results with matching populations, comparisons, and time points - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R01, R02, R03 ### N19 · Were shared reports, sibling questions, and the same participants kept from being counted as independent replication? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The two subclaim sheets share three bibliographic records and the parent stored summary. NCT02939638, NCT00276939, and NCT03354377 are preserved report by report. - Why unverified: 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. - Reason for missing information: Reports, tables, multiple endpoints, and repeated measurements are not added up as unique trials or total participants. The final independent count is not recorded. - Required materials and conditions: Study-family connections among original bibliography, trials, participants, and endpoints - Materials to obtain first: Reports, tables, multiple endpoints, and repeated measurements are not added up as unique trials or total participants. The final independent count is not recorded. - Further research: Connect additional reports through original trial identifiers while retaining same-population relationships. - Conditions for verification: Study-family connections among original bibliography, trials, participants, and endpoints - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R01, R02, R03 ### N20 · Are PCRM, public grants, and organizational author roles distinguished? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: Mixed support is not labeled as public funding alone. Organizational officers are not newly classified as pharmaceutical-manufacturer employees. - Required materials and conditions: Separate records of support, organizational roles, affiliations, design, analysis, and writing - Materials to obtain first: Mixed support is not labeled as public funding alone. Organizational officers are not newly classified as pharmaceutical-manufacturer employees. - Further research: Obtain original funding, affiliations, study roles, data-access, and analysis disclosures separately. - Conditions for verification: Separate records of support, organizational roles, affiliations, design, analysis, and writing - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R01 ### N21 · Are no food provision and gaps in other interests or external analysis roles distinguished? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: No provision of food or supplements is preserved alongside PCRM funding and participation by authors who were organizational officers. - Why unverified: 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. - Reason for missing information: 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. - Required materials and conditions: Separate materials on product provision, monetary support, affiliated authors, and external analysis services - Materials to obtain first: 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. - Further research: Connect original disclosures of sponsorship, products, affiliations, and external analysis and writing roles. - Conditions for verification: Separate materials on product provision, monetary support, affiliated authors, and external analysis services - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R01 ### N22 · Is the level of funding information preserved separately for the other two active-comparison trials? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The 74-week trial records NIH R01 DK059362 and other funding; NEW Soul's original wording is ‘Reported trial funding’. - Why unverified: 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. - Reason for missing information: The vague NEW Soul funding wording is not filled with a specific funder, no support, or confirmed independence. - Required materials and conditions: Original support, provision, affiliations, and analysis roles for each trial - Materials to obtain first: The vague NEW Soul funding wording is not filled with a specific funder, no support, or confirmed independence. - Further research: Obtain each trial's original support, affiliation, provision, and analysis disclosures separately. - Conditions for verification: Original support, provision, affiliations, and analysis roles for each trial - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R02, R03 ### N23 · Are prespecified safety outcomes, adverse-event comparisons, and unread materials distinguished? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: 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. - Required materials and conditions: Harm collection, group events, exposure, denominators, and prespecified plans - Materials to obtain first: 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. - Further research: Obtain original harm-collection methods, group events, exposure, discontinuations, and denominators. - Conditions for verification: Harm collection, group events, exposure, denominators, and prespecified plans - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R01 ### N24 · Are gaps in short-term and long-term nutritional harms and rare events preserved? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: The original safety record describes comparative materials as limited. - Why unverified: 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. - Reason for missing information: Specific counts, severity, or long-term incidence of nutritional harms absent from the original text are not invented. Benefit alone does not certify safety. - Required materials and conditions: Actual dietary exposure, discontinuation, group harms, and long-term follow-up - Materials to obtain first: Specific counts, severity, or long-term incidence of nutritional harms absent from the original text are not invented. Benefit alone does not certify safety. - Further research: Direct materials on actual exposure, discontinuation, nutrition-related measurements, rare harms, and long-term follow-up are needed. - Conditions for verification: Actual dietary exposure, discontinuation, group harms, and long-term follow-up - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R01 ### N25 · Was new certainty avoided for application to special populations, concomitant treatment, and replication of harms? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: The parent's existing safety explanation includes contexts of pregnancy, breastfeeding, eating disorders, and ongoing medication treatment. - Why unverified: 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. - Reason for missing information: 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. - Required materials and conditions: Population-specific direct comparisons, exposure, harms, and follow-up materials - Materials to obtain first: 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. - Further research: If direct materials and trial–harm relationships for those populations are provided, connect them separately. - Conditions for verification: Population-specific direct comparisons, exposure, harms, and follow-up materials - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R01 ### N26 · Are external links and registration identifiers separated from actual access status? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The entire parent stored summary was read for production, and the three original PubMed source links and registration identifiers were connected as preserved. - Why unverified: 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. - Reason for missing information: 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. - Required materials and conditions: Separate access records for summaries, abstracts, full texts, registrations, protocols, and SAPs - Materials to obtain first: 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. - Further research: Connect only materials obtained by the user, with separate access status for each. - Conditions for verification: Separate access records for summaries, abstracts, full texts, registrations, protocols, and SAPs - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R01, R02, R03 ### N27 · Are the reference date, Korean and English text, original axes, corrections, and empty values preserved? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: 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. - Required materials and conditions: Separate records of the full original text and subclaim and parent histories - Materials to obtain first: 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. - Further research: Proposal: Link new materials or decisions to separate change events while preserving original text. - Conditions for verification: Separate records of the full original text and subclaim and parent histories - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R01, R02, R03 ### N28 · Are production status, original content review, and independent certification distinguished? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: There is no new main claim, split, or independent certification; new units are 0 and the final independent count is not recorded. - Required materials and conditions: Separate records of existing candidate history, production, and review status - Materials to obtain first: There is no new main claim, split, or independent certification; new units are 0 and the final independent count is not recorded. - Further research: Reflect only user-provided decisions and materials as separate events. - Conditions for verification: Separate records of existing candidate history, production, and review status - Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question - Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Sixteen-week weight loss versus no diet change - Related sources: R01, R02, R03 ## Evidence and sources ### R01 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. [PubMed](https://pubmed.ncbi.nlm.nih.gov/33252690/) Materials actually read: Summary read; external materials not read Findings recorded in the summary: −6.4 kg versus −0.5 kg; treatment effect −5.9 kg (95% CI −6.8~−5.0), group×time P<0.001 Record level: Stored review summary; not a result of directly reading the original paper or registration Independent replication: 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. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | local_summary | Original source link preserved | Summary read | Summary read | Preserved parent verdict summary | | abstract | Original source link preserved | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review | | fulltext | No separate URL in the original material | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review | | registration | No separate URL in the original material | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review | | protocol_sap | No separate URL in the original material | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review | ### R02 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. [PubMed](https://pubmed.ncbi.nlm.nih.gov/19339401/) Materials actually read: Summary read; external materials not read Findings recorded in the summary: −4.4 kg versus −3.0 kg, between-group P=0.25 Record level: Stored review summary; not a result of directly reading the original paper or registration Independent replication: 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. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | local_summary | Original source link preserved | Summary read | Summary read | Preserved parent verdict summary | | abstract | Original source link preserved | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review | | fulltext | No separate URL in the original material | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review | | registration | No separate URL in the original material | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review | | protocol_sap | No separate URL in the original material | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review | ### R03 Effect of a Plant-Based vs Omnivorous Soul Food Diet on Weight and Lipid Levels Among African Americans. PMID: 36633848. NCT03354377. [PubMed](https://pubmed.ncbi.nlm.nih.gov/36633848/) Materials actually read: Summary read; external materials not read Findings recorded in the summary: −2.39 kg versus −2.03 kg, between-group P=.64 Record level: Stored review summary; not a result of directly reading the original paper or registration Independent replication: 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. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | local_summary | Original source link preserved | Summary read | Summary read | Preserved parent verdict summary | | abstract | Original source link preserved | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review | | fulltext | No separate URL in the original material | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review | | registration | No separate URL in the original material | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review | | protocol_sap | No separate URL in the original material | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed. - M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed. - M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed. - M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed. - M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed. ## What the statuses mean - 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 ## Change history 2026-10-11 · Public page/materials 1.0. Public reader pages and material were prepared from the existing 28 items. No new clinical searches, verification-state changes or scoring were performed.