Ad libitum low-fat vegan composite diet × Sixteen-week weight loss versus no diet change — Evidence checklist

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Comparative efficacyAre the selected sixteen-week comparison and subclaim grade distinguished from the parent context?Required	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. R01	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.	Separate records of the selected wording, grade, note, and parent verdict	If additional materials are provided, connect the selected question and the parent's application boundaries separately.
2	Partly verified	Full text not readStored summary read	N02 · Comparative efficacyWho were the overweight adults in the trial, and what were their baseline characteristics?Required	The original effect concerns overweight adults in a randomized trial of 244 participants. R01	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.	Eligibility, age, BMI, comorbidities, baseline weight, and group denominators	Obtain the original trial's eligibility criteria, baseline characteristics table, and denominators.
3	Partly verified	Full text not readStored summary read	N03 · Comparative efficacyWhat was the ad libitum low-fat vegan composite diet?Required	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. R01	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.	Study records of diet composition, education, support, actual intake, and exposure	Connect original materials on diet composition, education, actual intake, and adherence.
4	Partly verified	Full text not readStored summary read	N04 · Comparative efficacyAre food and supplement provision distinguished from classes and support?Required	The record states that food and supplements were not provided, while the vegan group received weekly classes and support. R01	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.	Original group records of food provision, supplements, contact, classes, and support	Obtain group records of classes, support, contact, participation, and exposure to food or supplements.
5	Partly verified	Full text not readStored summary read	N05 · Comparative efficacyAre a no-change control and other healthy-diet controls different comparisons?Required	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. R01	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.	Original records of actual control diet, management, and additional treatment	Connect the original control's actual exposure and direct comparisons with other healthy diets separately.
6	Partly verified	Full text not readStored summary read	N06 · Comparative efficacyDoes ad libitum establish matched actual calories or intake?Required	The stored summary explains that ‘eating freely’ meant no prescribed calorie restriction. R01	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.	Distinction between prescribed calories, actual intake, energy differences, and study exposure	Connect actual intake, exposure, energy measurements, and prespecified analysis materials when provided.
7	Partly verified	Full text not readStored summary read	N07 · Comparative efficacyWhat were the units, methods, and timing of sixteen-week weight measurement?Required	The endpoint was 16-week weight change. The existing review summary quotes measurement using a calibrated scale accurate to 0.1kg. R01	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.	Baseline and sixteen-week measurements, calibrated scale, units, and procedures	Obtain original measurement procedures, group labels, and values at each time point.
8	Partly verified	Full text not readStored summary read	N08 · Comparative efficacyAre within-group weight changes and the between-group treatment effect preserved as recorded?Required	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. R01	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.	Original materials for group changes, treatment effect, CI, and testing	Connect the original between-group model, effect, interval, denominators, and group tables.
9	Partly verified	Full text not readStored summary read	N09 · Comparative efficacyAre randomization, completion, and analysis populations distinguished?Required	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. R01	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.	Allocation, completion, ITT, missing data, and group analysis denominators	Obtain group follow-up flow, analysis populations, reasons for missing data, and endpoint-specific denominators.
10	Partly verified	Full text not readStored summary read	N10 · Comparative efficacyAre the limitations of ITT and a repeated-measures model incorporating missing data recorded?Required	The existing review summary quotes an ITT analysis including all participants and missing data incorporated in a repeated-measures model. R01	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.	Prespecified original plans for model, missing-data assumptions, variables, sensitivity, and exclusions	Obtain the original SAP and materials on missing-data handling, group attrition, and sensitivity analyses.
11	Partly verified	Full text not readStored summary read	N11 · Comparative efficacyWhat information is available about allocation, participant masking, and measurement procedures?Required	The existing review summary records wording about 1:1 randomization and infeasibility of masking diet participants, and describes calibrated-scale measurement. R01	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.	Original methods for allocation, concealment, and assessor and analyst masking	Obtain original allocation, concealment, assessor, and analyst procedures and methods.
12	Partly verified	Full text not readStored summary read	N12 · Comparative efficacyAre multiple primary outcomes distinguished from the prespecified hierarchy of the weight question?Required	The quoted original primary outcomes were body weight, insulin resistance, postprandial metabolism, and intramyocellular and hepatocellular lipid levels. The record states consistency with NCT02939638. R01	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.	Original records of registration, protocol, SAP, multiplicity, and effect of interest	Connect outcome hierarchy, testing, and change histories in the registration, protocol, and SAP.
13	Partly verified	Full text not readStored summary read	N13 · Comparative efficacyIs a large kilogram difference distinguished from a verified clinical-importance threshold?Required	The stored summary rates the −5.9kg effect as large but records that no minimum clinically important weight-loss threshold was declared in advance. R01	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.	Prespecified minimum clinically important weight-loss threshold and original plan for the selected population and duration	Connect prespecified importance, meaningful response, and population-specific application plans when provided.
14	Partly verified	Full text not readStored summary read	N14 · Comparative efficacyAre weight, other surrogate outcomes, body composition, and mechanisms supported separately?Required	Insulin sensitivity, metabolism, and intracellular lipids appear in the original bibliography and quoted multiple primary outcomes. R01	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.	Endpoint-specific materials for weight, insulin, postprandial metabolism, body composition, and intracellular lipids	Obtain each endpoint's definition, measurement, denominators, effect, CI, and prespecified plan separately.
15	Partly verified	Full text not readStored summary read	N15 · Comparative efficacyWas the sixteen-week result extended to long-term maintenance, disease, or death?Required	The parent describes weight as a surrogate for clinical events and records long-term maintenance, cardiovascular disease prevention, and diabetes treatment as separate questions. R01	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.	Direct follow-up, denominators, and effects for long-term weight and clinical events	Connect separate long-term direct comparisons and clinical-event materials for the relevant population.
16	Partly verified	Full text not readStored summary read	N16 · Comparative efficacyIs the seventy-four-week diabetes-diet comparison the same as a sixteen-week no-change comparison?Required	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. R02	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.	Direct comparisons and original denominators separated by population, comparator, and duration	Connect each trial's population, diet composition, denominators, effect, and CI separately.
17	Partly verified	Full text not readStored summary read	N17 · Comparative efficacyDoes the NEW Soul active-control result concern a different population and duration?Required	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. R03	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.	Original NEW Soul materials on population, the two diets, endpoints, and denominators	Obtain NEW Soul's original population, comparator composition, denominators, hierarchy, and CI.
18	Partly verified	Full text not readStored summary read	N18 · Comparative efficacyAre null active-comparison results kept separate from the original sixteen-week E+ and R1?Required	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. R01 R02 R03	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.	Relationships between results with matching populations, comparisons, and time points	Connect each comparison question's plan, CI, importance, and application scope separately.
19	Partly verified	Full text not readStored summary read	N19 · Comparative efficacyWere shared reports, sibling questions, and the same participants kept from being counted as independent replication?Required	The two subclaim sheets share three bibliographic records and the parent stored summary. NCT02939638, NCT00276939, and NCT03354377 are preserved report by report. R01 R02 R03	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.	Study-family connections among original bibliography, trials, participants, and endpoints	Connect additional reports through original trial identifiers while retaining same-population relationships.
20	Partly verified	Full text not readStored summary read	N20 · Comparative efficacyAre PCRM, public grants, and organizational author roles distinguished?Required	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. R01	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.	Separate records of support, organizational roles, affiliations, design, analysis, and writing	Obtain original funding, affiliations, study roles, data-access, and analysis disclosures separately.
21	Partly verified	Full text not readStored summary read	N21 · Comparative efficacyAre no food provision and gaps in other interests or external analysis roles distinguished?Required	No provision of food or supplements is preserved alongside PCRM funding and participation by authors who were organizational officers. R01	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.	Separate materials on product provision, monetary support, affiliated authors, and external analysis services	Connect original disclosures of sponsorship, products, affiliations, and external analysis and writing roles.
22	Partly verified	Full text not readStored summary read	N22 · Comparative efficacyIs the level of funding information preserved separately for the other two active-comparison trials?Required	The 74-week trial records NIH R01 DK059362 and other funding; NEW Soul's original wording is ‘Reported trial funding’. R02 R03	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.	Original support, provision, affiliations, and analysis roles for each trial	Obtain each trial's original support, affiliation, provision, and analysis disclosures separately.
23	Partly verified	Full text not readStored summary read	N23 · Supplementary harm evidenceAre prespecified safety outcomes, adverse-event comparisons, and unread materials distinguished?Required	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. R01	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.	Harm collection, group events, exposure, denominators, and prespecified plans	Obtain original harm-collection methods, group events, exposure, discontinuations, and denominators.
24	Unverified	Full text not readStored summary read	N24 · Supplementary harm evidenceAre gaps in short-term and long-term nutritional harms and rare events preserved?Required	The original safety record describes comparative materials as limited. R01	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.	Actual dietary exposure, discontinuation, group harms, and long-term follow-up	Direct materials on actual exposure, discontinuation, nutrition-related measurements, rare harms, and long-term follow-up are needed.
25	Unverified	Full text not readStored summary read	N25 · Supplementary harm evidenceWas new certainty avoided for application to special populations, concomitant treatment, and replication of harms?Required	The parent's existing safety explanation includes contexts of pregnancy, breastfeeding, eating disorders, and ongoing medication treatment. R01	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.	Population-specific direct comparisons, exposure, harms, and follow-up materials	If direct materials and trial–harm relationships for those populations are provided, connect them separately.
26	Partly verified	Full text not readStored summary read	N26 · Comparative efficacyAre external links and registration identifiers separated from actual access status?Required	The entire parent stored summary was read for production, and the three original PubMed source links and registration identifiers were connected as preserved. R01 R02 R03	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.	Separate access records for summaries, abstracts, full texts, registrations, protocols, and SAPs	Connect only materials obtained by the user, with separate access status for each.
27	Partly verified	Full text not readStored summary read	N27 · Comparative efficacyAre the reference date, Korean and English text, original axes, corrections, and empty values preserved?Required	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. R01 R02 R03	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.	Separate records of the full original text and subclaim and parent histories	Proposal: Link new materials or decisions to separate change events while preserving original text.
28	Partly verified	Full text not readStored summary read	N28 · Comparative efficacyAre production status, original content review, and independent certification distinguished?Supplementary	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. R01 R02 R03	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.	Separate records of existing candidate history, production, and review status	Reflect only user-provided decisions and materials as separate events.

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28 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
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

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

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

Material type: Trial report
Materials actually read: Summary read; external materials not read
Findings recorded in the stored 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
Study overlap and 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.

Public availability, access and reading status by material
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

Material type: Trial report
Materials actually read: Summary read; external materials not read
Findings recorded in the stored 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
Study overlap and 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.

Public availability, access and reading status by material
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

Material type: Trial report
Materials actually read: Summary read; external materials not read
Findings recorded in the stored 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
Study overlap and 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.

Public availability, access and reading status by material
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

Report counts versus independent study counts

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.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Are the selected sixteen-week comparison and subclaim grade distinguished from the parent context?

Required materials and conditions: Separate records of the selected wording, grade, note, and parent verdict
Conditions for verification: Separate records of the selected wording, grade, note, and parent verdict
Requirement and applicability: Required
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

N02 · Who were the overweight adults in the trial, and what were their baseline characteristics?

Required materials and conditions: Eligibility, age, BMI, comorbidities, baseline weight, and group denominators
Conditions for verification: Eligibility, age, BMI, comorbidities, baseline weight, and group denominators
Requirement and applicability: Required
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

N03 · What was the ad libitum low-fat vegan composite diet?

Required materials and conditions: Study records of diet composition, education, support, actual intake, and exposure
Conditions for verification: Study records of diet composition, education, support, actual intake, and exposure
Requirement and applicability: Required
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

N04 · Are food and supplement provision distinguished from classes and support?

Required materials and conditions: Original group records of food provision, supplements, contact, classes, and support
Conditions for verification: Original group records of food provision, supplements, contact, classes, and support
Requirement and applicability: Required
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

N05 · Are a no-change control and other healthy-diet controls different comparisons?

Required materials and conditions: Original records of actual control diet, management, and additional treatment
Conditions for verification: Original records of actual control diet, management, and additional treatment
Requirement and applicability: Required
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

N06 · Does ad libitum establish matched actual calories or intake?

Required materials and conditions: Distinction between prescribed calories, actual intake, energy differences, and study exposure
Conditions for verification: Distinction between prescribed calories, actual intake, energy differences, and study exposure
Requirement and applicability: Required
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

N07 · What were the units, methods, and timing of sixteen-week weight measurement?

Required materials and conditions: Baseline and sixteen-week measurements, calibrated scale, units, and procedures
Conditions for verification: Baseline and sixteen-week measurements, calibrated scale, units, and procedures
Requirement and applicability: Required
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

N08 · Are within-group weight changes and the between-group treatment effect preserved as recorded?

Required materials and conditions: Original materials for group changes, treatment effect, CI, and testing
Conditions for verification: Original materials for group changes, treatment effect, CI, and testing
Requirement and applicability: Required
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

N09 · Are randomization, completion, and analysis populations distinguished?

Required materials and conditions: Allocation, completion, ITT, missing data, and group analysis denominators
Conditions for verification: Allocation, completion, ITT, missing data, and group analysis denominators
Requirement and applicability: Required
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

N10 · Are the limitations of ITT and a repeated-measures model incorporating missing data recorded?

Required materials and conditions: Prespecified original plans for model, missing-data assumptions, variables, sensitivity, and exclusions
Conditions for verification: Prespecified original plans for model, missing-data assumptions, variables, sensitivity, and exclusions
Requirement and applicability: Required
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

N11 · What information is available about allocation, participant masking, and measurement procedures?

Required materials and conditions: Original methods for allocation, concealment, and assessor and analyst masking
Conditions for verification: Original methods for allocation, concealment, and assessor and analyst masking
Requirement and applicability: Required
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

N12 · Are multiple primary outcomes distinguished from the prespecified hierarchy of the weight question?

Required materials and conditions: Original records of registration, protocol, SAP, multiplicity, and effect of interest
Conditions for verification: Original records of registration, protocol, SAP, multiplicity, and effect of interest
Requirement and applicability: Required
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

N13 · Is a large kilogram difference distinguished from a verified clinical-importance threshold?

Required materials and conditions: Prespecified minimum clinically important weight-loss threshold and original plan for the selected population and duration
Conditions for verification: Prespecified minimum clinically important weight-loss threshold and original plan for the selected population and duration
Requirement and applicability: Required
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

N14 · Are weight, other surrogate outcomes, body composition, and mechanisms supported separately?

Required materials and conditions: Endpoint-specific materials for weight, insulin, postprandial metabolism, body composition, and intracellular lipids
Conditions for verification: Endpoint-specific materials for weight, insulin, postprandial metabolism, body composition, and intracellular lipids
Requirement and applicability: Required
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

N15 · Was the sixteen-week result extended to long-term maintenance, disease, or death?

Required materials and conditions: Direct follow-up, denominators, and effects for long-term weight and clinical events
Conditions for verification: Direct follow-up, denominators, and effects for long-term weight and clinical events
Requirement and applicability: Required
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

N16 · Is the seventy-four-week diabetes-diet comparison the same as a sixteen-week no-change comparison?

Required materials and conditions: Direct comparisons and original denominators separated by population, comparator, and duration
Conditions for verification: Direct comparisons and original denominators separated by population, comparator, and duration
Requirement and applicability: Required
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

N17 · Does the NEW Soul active-control result concern a different population and duration?

Required materials and conditions: Original NEW Soul materials on population, the two diets, endpoints, and denominators
Conditions for verification: Original NEW Soul materials on population, the two diets, endpoints, and denominators
Requirement and applicability: Required
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

N18 · Are null active-comparison results kept separate from the original sixteen-week E+ and R1?

Required materials and conditions: Relationships between results with matching populations, comparisons, and time points
Conditions for verification: Relationships between results with matching populations, comparisons, and time points
Requirement and applicability: Required
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

N19 · Were shared reports, sibling questions, and the same participants kept from being counted as independent replication?

Required materials and conditions: Study-family connections among original bibliography, trials, participants, and endpoints
Conditions for verification: Study-family connections among original bibliography, trials, participants, and endpoints
Requirement and applicability: Required
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

N20 · Are PCRM, public grants, and organizational author roles distinguished?

Required materials and conditions: Separate records of support, organizational roles, affiliations, design, analysis, and writing
Conditions for verification: Separate records of support, organizational roles, affiliations, design, analysis, and writing
Requirement and applicability: Required
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

N21 · Are no food provision and gaps in other interests or external analysis roles distinguished?

Required materials and conditions: Separate materials on product provision, monetary support, affiliated authors, and external analysis services
Conditions for verification: Separate materials on product provision, monetary support, affiliated authors, and external analysis services
Requirement and applicability: Required
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

N22 · Is the level of funding information preserved separately for the other two active-comparison trials?

Required materials and conditions: Original support, provision, affiliations, and analysis roles for each trial
Conditions for verification: Original support, provision, affiliations, and analysis roles for each trial
Requirement and applicability: Required
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

N23 · Are prespecified safety outcomes, adverse-event comparisons, and unread materials distinguished?

Required materials and conditions: Harm collection, group events, exposure, denominators, and prespecified plans
Conditions for verification: Harm collection, group events, exposure, denominators, and prespecified plans
Requirement and applicability: Required
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

N24 · Are gaps in short-term and long-term nutritional harms and rare events preserved?

Required materials and conditions: Actual dietary exposure, discontinuation, group harms, and long-term follow-up
Conditions for verification: Actual dietary exposure, discontinuation, group harms, and long-term follow-up
Requirement and applicability: Required
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

N25 · Was new certainty avoided for application to special populations, concomitant treatment, and replication of harms?

Required materials and conditions: Population-specific direct comparisons, exposure, harms, and follow-up materials
Conditions for verification: Population-specific direct comparisons, exposure, harms, and follow-up materials
Requirement and applicability: Required
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

N26 · Are external links and registration identifiers separated from actual access status?

Required materials and conditions: Separate access records for summaries, abstracts, full texts, registrations, protocols, and SAPs
Conditions for verification: Separate access records for summaries, abstracts, full texts, registrations, protocols, and SAPs
Requirement and applicability: Required
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

N27 · Are the reference date, Korean and English text, original axes, corrections, and empty values preserved?

Required materials and conditions: Separate records of the full original text and subclaim and parent histories
Conditions for verification: Separate records of the full original text and subclaim and parent histories
Requirement and applicability: Required
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

N28 · Are production status, original content review, and independent certification distinguished?

Required materials and conditions: Separate records of existing candidate history, production, and review status
Conditions for verification: Separate records of existing candidate history, production, and review status
Requirement and applicability: Supplementary
Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
Referenced methods: Sixteen-week weight loss versus no diet change

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: 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

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: 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

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: 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

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: 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

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: 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/material version 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.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Are the selected sixteen-week comparison and subclaim grade distinguished from the parent context?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
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?

Current findings: The original effect concerns overweight adults in a randomized trial of 244 participants.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
Referenced methods: Sixteen-week weight loss versus no diet change

Related sources R01

N03 · What was the ad libitum low-fat vegan composite diet?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
Referenced methods: Sixteen-week weight loss versus no diet change

Related sources R01

N04 · Are food and supplement provision distinguished from classes and support?

Current findings: The record states that food and supplements were not provided, while the vegan group received weekly classes and support.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
Referenced methods: Sixteen-week weight loss versus no diet change

Related sources R01

N06 · Does ad libitum establish matched actual calories or intake?

Current findings: The stored summary explains that ‘eating freely’ meant no prescribed calorie restriction.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
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?

Current findings: The endpoint was 16-week weight change. The existing review summary quotes measurement using a calibrated scale accurate to 0.1kg.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
Referenced methods: Sixteen-week weight loss versus no diet change

Related sources R01

N09 · Are randomization, completion, and analysis populations distinguished?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
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?

Current findings: The existing review summary quotes an ITT analysis including all participants and missing data incorporated in a repeated-measures model.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
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?

Current findings: The existing review summary records wording about 1:1 randomization and infeasibility of masking diet participants, and describes calibrated-scale measurement.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
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?

Current findings: Insulin sensitivity, metabolism, and intracellular lipids appear in the original bibliography and quoted multiple primary outcomes.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
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?

Current findings: The two subclaim sheets share three bibliographic records and the parent stored summary. NCT02939638, NCT00276939, and NCT03354377 are preserved report by report.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
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?

Current findings: No provision of food or supplements is preserved alongside PCRM funding and participation by authors who were organizational officers.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
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?

Current findings: The 74-week trial records NIH R01 DK059362 and other funding; NEW Soul's original wording is ‘Reported trial funding’.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
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?

Current findings: The original safety record describes comparative materials as limited.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
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?

Current findings: The parent's existing safety explanation includes contexts of pregnancy, breastfeeding, eating disorders, and ongoing medication treatment.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
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.
Referenced methods: Sixteen-week weight loss versus no diet change

Related sources R01 R02 R03