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Ad libitum low-fat vegan composite diet × Superior weight loss versus another healthful diet — Comparator-specific evidence checklist

Select a review item to see its details.
Required evidence, verification status and materials actually read
ItemAVerification statusBReading scopeCReview itemDCurrent findingsEWhy unverifiedFRequired materials and conditionsGFurther research
1 Partly verified Full text not readStored summary read N01 · Comparative efficacyAre the selected superiority claim against active healthy diets and the parent's no-change effect separated?Required
The original subclaim is ‘Superior weight loss versus another healthful diet’, with original grade D and a note of 74-week diabetes-diet trial P=0.25. The parent is C, 54, Caution.
R02 R03
Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Absent subclaim score, status, and assessment axes are not filled with parent values. Null effects across all other healthy diets are not newly certified.
Separate records of the selected wording, grade, note, and parent comparison
If additional materials are provided, distinguish and connect results matched to comparator, population, and duration.
2 Partly verified Full text not readStored summary read N02 · Comparative efficacyWhich diets were actually meant by the comparator ‘another healthful diet’?Required
The original active controls were a conventional diabetes diet over 74 weeks and NEW Soul's low-fat omnivorous soul food diet.
R02 R03
Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. All other healthy diets are not treated as one identical comparator. Detailed composition, exposure, and education for each diet remain unread.
Composition, education, exposure, support, and denominators for a specific active diet
Obtain original descriptions, common management, and actual intake materials for each active diet.
3 Partly verified Full text not readStored summary read N03 · Comparative efficacyWas the actual control in the sixteen-week trial an active healthy diet?Required
The 16-week trial of 244 participants compared 122 assigned to a vegan diet with 122 assigned to no diet change.
R01
Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. The direct −5.9kg result does not fill the gap in superiority over another healthy diet in the same population at sixteen weeks.
Identity of the control and direct comparison in the relevant sixteen-week trial
If materials on a specific active healthy-diet control in the same population and duration are provided, connect them separately.
4 Partly verified Full text not readStored summary read N04 · Comparative efficacyWhat were the population and denominators for the seventy-four-week diabetes-diet comparison?Required
The 74-week trial is recorded as randomizing 99 participants with type 2 diabetes.
R02
Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. This is not transferred to the same population as general overweight adults. Eligibility, group allocation and analysis, baseline weight, and treatment details remain unread.
Type 2 diabetes population, eligibility, and group allocation and analysis denominators
Obtain original eligibility, baseline status, group denominators, and concomitant-treatment tables.
5 Partly verified Full text not readStored summary read N05 · Comparative efficacyWhat were the composite components and accompanying management of the seventy-four-week intervention and control?Required
The original study design was a randomized trial of a low-fat vegan diet versus a conventional diabetes diet.
R02
Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Calories, nutritional composition, attention, support, and medication changes are not newly assumed equal between groups. No dietary or medication instructions are created.
Original records of low-fat vegan and conventional diabetes diets, education, and concomitant treatment
Obtain records of each composite diet's composition, actual intake, contact, and concomitant treatment.
6 Partly verified Full text not readStored summary read N06 · Comparative efficacyAre the seventy-four-week weight results and gaps in the between-group effect preserved?Required
At 74 weeks, weight changes were −4.4kg with the vegan diet versus −3.0kg with a conventional diabetes diet, between-group P=0.25.
R02
Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. No new mean difference, CI, quantitative response, or NNT is calculated. The original between-group effect, CI, analysis model, and denominators are absent from the summary.
Group changes, between-group effect, CI, testing, and denominators
Obtain the original effect, interval, model, denominators, and weight-measurement methods.
7 Unverified Full text not readStored summary read N07 · Comparative efficacyAre seventy-four-week follow-up, attrition, ITT, and missing-data details directly verified?Required
The 74-week duration and 99 randomized participants are preserved.
R02
Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Wording about 222 completers, repeated measures, and ITT including all participants concerns the sixteen-week trial and is not transferred to seventy-four weeks.
Group follow-up, analysis populations, reasons for missing data, sensitivity, and actual exposure
Obtain original participant flow, missing-data handling, analysis populations, and adherence materials for the seventy-four-week trial.
8 Partly verified Full text not readStored summary read N08 · Comparative efficacyWhat were NEW Soul's actual population and application boundaries?Required
The NEW Soul bibliography specifies African Americans and records 159 randomized participants.
R03
Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Detailed eligibility, including age, BMI, and comorbidities, remains unread. Results are not newly extended to all overweight adults or all regions.
Original materials on recruitment, baseline status, group denominators, and existing diet
Obtain original recruitment, eligibility, baseline status, and group denominators.
9 Partly verified Full text not readStored summary read N09 · Comparative efficacyWhat were the actual vegan and low-fat omnivorous soul food diets compared in NEW Soul?Required
The original study design was a randomized active-control trial of vegan versus low-fat omnivorous soul food diets.
R03
Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Results are not generalized to all vegan diets or all omnivorous healthy diets, and the sixteen-week diet composition is not copied unchanged.
Composition, exposure, education, support, and accompanying management for the two composite diets
Obtain NEW Soul's original diet composition, contact, support, actual intake, and adherence.
10 Partly verified Full text not readStored summary read N10 · Comparative efficacyIs NEW Soul's twelve-month primary weight result preserved as recorded?Required
At 12 months, primary weight changes were −2.39kg with the vegan diet versus −2.03kg with the low-fat omnivorous diet, between-group P=.64.
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 mean difference, response count, CI, or equivalence verdict is created. Group analysis denominators, original CI, and model remain unread.
Primary outcome, group changes, original between-group effect, CI, and testing
Obtain the original primary-outcome plan, group denominators, effect, CI, and measurement materials.
11 Unverified Full text not readStored summary read N11 · Comparative efficacyAre NEW Soul's long-term follow-up, denominators, and missing-data details directly presented?Required
The original materials record 159 randomized participants and 12-month results.
R03
Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. The 159 randomized participants are not confirmed as the analysis denominator for every twelve-month result, and the sixteen-week 91.0% completion rate is not transferred.
Records of allocation, twelve-month observations, ITT, attrition, missing data, and sensitivity
Obtain original participant flow, group missing data, ITT, analysis populations, and adherence materials.
12 Partly verified Full text not readStored summary read N12 · Comparative efficacyAre nonsignificant P values in active comparisons distinguished from limits on superiority and equivalence?Required
The stored summary records that 74-week P=0.25 and NEW Soul P=.64 did not show superiority over active controls.
R02 R03
Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Without CI, thresholds, or an equivalence design, zero for every difference or equivalence with all healthy diets is not newly confirmed.
Effect, CI, importance, and prespecified superiority or equivalence plans
Connect the relevant comparison scope when the original CI, testing plan, and importance threshold are provided.
13 Partly verified Full text not readStored summary read N13 · Comparative efficacyDoes the direct-evidence gap remain for an active control with matching population, duration, and support?Required
The current active comparisons concern type 2 diabetes at 74 weeks and NEW Soul at 12 months; their populations, durations, and controls differ from the 16-week no-change trial.
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. Existing active comparisons are not erased as nonexistent, but a direct comparison matching the original sixteen-week conditions is not newly confirmed.
Direct materials with an active control, population, and duration matching the original sixteen-week question
Direct materials for a specific active healthy-diet comparison with matched population, duration, education, and attention are needed.
14 Partly verified Full text not readStored summary read N14 · Comparative efficacyAre the large no-change effect and active comparisons preserved separately?Required
The original 16-week values are retained: vegan −6.4kg versus no change −0.5kg, treatment effect −5.9kg (95% CI −6.8~−5.0), group×time P<0.001.
R01
Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. These are not transferred to a mean difference or CI versus an active healthy diet. The original verdict that sixteen-week E+ was unchanged because the comparator differed is retained.
Effect, interval, testing, time point, and denominators for each comparison
Connect each comparison's original model, effect, interval, population, and duration separately.
15 Partly verified Full text not readStored summary read N15 · Comparative efficacyAre common education, attention, and calorie conditions in the sixteen-week trial distinguished from active comparisons?Required
The 16-week vegan group received weekly classes and support; food and supplements were not provided. Ad libitum meant no prescribed calorie restriction.
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. Education differences in the sixteen-week trial are not ignored or copied as identical conditions across all active comparisons. Equal actual calories or an independent mechanism is not newly asserted.
Original group materials on education, contact, support, actual calories, and exposure
Obtain education, attention, calories, intake, and accompanying-exposure materials for each trial separately.
16 Partly verified Full text not readStored summary read N16 · Comparative efficacyWhat was the original scope of open dietary allocation, masking, and measurement procedures?Required
The stored summary records the 16-week trial as open-label and parallel-group, with infeasible participant masking and calibrated-scale measurement.
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. These details are not transferred to allocation and measurement procedures in the seventy-four-week trial or NEW Soul. The parent's B0 is historical.
Original trial-specific materials on allocation concealment, masking, assessors, and analysts
Obtain original allocation, concealment, measurement, and analysis procedures for each active-comparison trial.
17 Partly verified Full text not readStored summary read N17 · Comparative efficacyAre prespecified endpoint hierarchies, multiple outcomes, and testing plans separated by trial?Required
The record quotes multiple primary outcomes including weight for the 16-week trial and primary 12-month weight for NEW Soul.
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. The seventy-four-week weight hierarchy or multiplicity adjustment in active comparisons is not invented. The sixteen-week coprimary split is preserved as its original false value.
Trial-specific registration, protocol, SAP, multiplicity, and change records
Obtain each trial's original registration, protocol, SAP, change history, and outcome hierarchy.
18 Partly verified Full text not readStored summary read N18 · Comparative efficacyAre results for weight, body composition, lipids, insulin, and mechanisms separated?Required
The original 16-week bibliography includes insulin sensitivity, metabolism, and intracellular lipids; NEW Soul's bibliography includes weight and lipids.
R01 R03
Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Original weight values are not copied as effects on other measures, body composition, or mechanisms. Those numerical results are not invented in this stored summary.
Actual measurements, effects, denominators, and prespecified plans for each measure
Obtain original measurements, effect, CI, and denominators for each measure separately.
19 Partly verified Full text not readStored summary read N19 · Comparative efficacyWere results kept from being extended to long-term maintenance, disease, death, or diabetes treatment?Required
The parent explicitly identifies long-term maintenance, clinical events, and superiority over another healthy diet as separate questions. Weight results at 74 weeks and 12 months concern those durations.
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. Some longer durations are not extended to benefits or null effects for all long-term maintenance, disease, death, or treatment outcomes.
Long-term direct materials separated by endpoint, population, and duration
Connect direct follow-up, effects, and denominators for each long-term question separately.
20 Partly verified Full text not readStored summary read N20 · Comparative efficacyAre shared bibliography, trials, populations, and sibling sheets preserved?Required
The two subclaim sheets share three reports and registration identifiers. The original 16-week single-trial, R1, and mixed-independence wording belongs to parent history.
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. Two sheets, multiple endpoints, and long-term measurements are not added up as unique trials, total participants, or new independent replication.
Study-family connections among reports, original trials, the same populations, endpoints, and time points
Connect additional reports to existing identifiers without confirming a final independent count.
21 Partly verified Full text not readStored summary read N21 · Comparative efficacyAre PCRM, public funding, and authors who were advocacy-organization officers preserved for the sixteen-week trial?Required
PCRM, Yale, and NIH funding and participation by PCRM clinical-research director Kahleova and president Barnard are preserved. 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. Public support alone is not described as confirming independence, and organizational officers are not newly classified as pharmaceutical-manufacturer employees.
Records of each funder, organizational affiliation, provision, analysis, and writing role
Obtain original support, affiliation, design, analysis, writing, and data-access disclosures separately.
22 Partly verified Full text not readStored summary read N22 · Comparative efficacyAre gaps in support, provision, authors, and external analysis kept separate for active-comparison trials?Required
Funding information for the 74-week trial records NIH R01 DK059362 and other support; NEW Soul is recorded as ‘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. No food provision and PCRM disclosures in the sixteen-week trial are not copied to other trials, and vague funding is not filled as absent or public. External analysis services also remain unverified.
Trial-specific records of monetary support, products, affiliated authors, and external analysis roles
Obtain original support, provision, affiliation, and analysis disclosures for each active-comparison trial.
23 Unverified Full text not readStored summary read N23 · Supplementary harm evidenceAre there direct comparative safety materials between active controls?Required
The original materials record that the 16-week trial did not report a prespecified primary safety outcome or between-group adverse-event table.
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. This non-reporting wording is not copied to all harm results in the two active-comparison trials. Detailed harm tables for the selected comparisons remain unread.
Group harm definitions, collection, events, exposure, denominators, and plans
Obtain original harm collection, group events, exposure, denominators, and discontinuation materials for each active-comparison trial.
24 Unverified Full text not readStored summary read N24 · Supplementary harm evidenceAre gaps in long-term exposure, rare harms, and discontinuation retained?Required
The original active-comparison durations were 74 weeks and 12 months. The parent's safety status is preserved as Caution.
R02 R03
Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Duration alone does not confirm long-term safety. Counts, rates, severity, or CIs for nutritional harms absent from the original text are not generated.
Actual exposure, discontinuation, serious events, and long-term follow-up by duration
Original group harm and discontinuation materials with actual exposure and sufficient duration for each diet are needed.
25 Unverified Full text not readStored summary read N25 · Supplementary harm evidenceAre special populations, concomitant treatment, replication of harms, and application scope distinguished?Required
The original safety context includes pregnancy, breastfeeding, eating disorders, and people undergoing medication treatment.
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 instructions for diet or treatment changes are created for them, and direct effects or replication of harms in those populations are not confirmed.
Population-specific direct comparisons, harms, concomitant treatment, and independent-report relationships
If direct materials for those populations are provided, connect original trials, exposure, and denominators separately.
26 Partly verified Full text not readStored summary read N26 · Comparative efficacyIs actual access to external papers, registrations, protocols, and SAPs recorded separately?Required
The three PubMed URLs and NCT02939638, NCT00276939, and NCT03354377 are connected as recorded, and the summary was read for production.
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 constructed from an identifier; external abstracts, full texts, registrations, protocols, and SAPs remain unread. No separate external-link checks were performed.
Original links, identifiers, stored summaries, and actual access records for each material
Connect only materials obtained by the user, with separate type and access status.
27 Partly verified Full text not readStored summary read N27 · Comparative efficacyAre original dates, Korean and English text, corrections, axes, empty values, and subclaim D preserved?Required
The reference date 2026-08-26, an empty corrections array, an empty deliberation string, Korean and English text, parent C54, Caution, original assessment axes, and subclaim D are preserved.
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. Absent subclaim values are not filled with the parent score. Historical cross-checking is not described as completed review here.
Separate preservation of the full parent stored summary, selected record, languages, and historical values
Connect new materials or decisions through preservation of original text and separate events.
28 Partly verified Full text not readStored summary read N28 · Comparative efficacyAre original content-review status, existing candidate history, and production completion separated?Supplementary
Existing candidate pending and production-eligibility markers and boundary requirements are preserved as history, while the current marker indicates incomplete original content review. Active pending and completion flags for model, content, and boundary review are false.
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; additional units are 0 and the final independent count is not recorded.
Records of historical candidate values and current 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
The seventy-four-week conventional diabetes diet and twelve-month low-fat omnivorous soul food comparisons are separated; the sixteen-week trial had a no-change control
Measured outcome
Selected superiority in weight loss versus active healthy diets; endpoint, nonsignificance, and equivalence boundaries are retained
Duration
Active comparisons at seventy-four weeks and twelve months; detailed evidence for an active comparison in the same original sixteen-week population remains a gap
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
MaterialPublic availabilityAccess statusActually readNotes
local_summaryOriginal source link preservedSummary readSummary readPreserved parent verdict summary
abstractOriginal source link preservedNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review
fulltextNo separate URL in the original materialNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review
registrationNo separate URL in the original materialNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review
protocol_sapNo separate URL in the original materialNot readNot readExternal 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
MaterialPublic availabilityAccess statusActually readNotes
local_summaryOriginal source link preservedSummary readSummary readPreserved parent verdict summary
abstractOriginal source link preservedNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review
fulltextNo separate URL in the original materialNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review
registrationNo separate URL in the original materialNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review
protocol_sapNo separate URL in the original materialNot readNot readExternal 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
MaterialPublic availabilityAccess statusActually readNotes
local_summaryOriginal source link preservedSummary readSummary readPreserved parent verdict summary
abstractOriginal source link preservedNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review
fulltextNo separate URL in the original materialNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review
registrationNo separate URL in the original materialNot readNot readExternal material unread; a URL does not mean acquisition, reading or completed review
protocol_sapNo separate URL in the original materialNot readNot readExternal 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 superiority claim against active healthy diets and the parent's no-change effect separated?
Required materials and conditions
Separate records of the selected wording, grade, note, and parent comparison
Conditions for verification
Separate records of the selected wording, grade, note, and parent comparison
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
Superior weight loss versus another healthful diet
N02 · Which diets were actually meant by the comparator ‘another healthful diet’?
Required materials and conditions
Composition, education, exposure, support, and denominators for a specific active diet
Conditions for verification
Composition, education, exposure, support, and denominators for a specific active diet
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
Superior weight loss versus another healthful diet
N03 · Was the actual control in the sixteen-week trial an active healthy diet?
Required materials and conditions
Identity of the control and direct comparison in the relevant sixteen-week trial
Conditions for verification
Identity of the control and direct comparison in the relevant sixteen-week 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
Superior weight loss versus another healthful diet
N04 · What were the population and denominators for the seventy-four-week diabetes-diet comparison?
Required materials and conditions
Type 2 diabetes population, eligibility, and group allocation and analysis denominators
Conditions for verification
Type 2 diabetes population, eligibility, and group allocation and 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
Superior weight loss versus another healthful diet
N05 · What were the composite components and accompanying management of the seventy-four-week intervention and control?
Required materials and conditions
Original records of low-fat vegan and conventional diabetes diets, education, and concomitant treatment
Conditions for verification
Original records of low-fat vegan and conventional diabetes diets, education, and concomitant 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
Superior weight loss versus another healthful diet
N06 · Are the seventy-four-week weight results and gaps in the between-group effect preserved?
Required materials and conditions
Group changes, between-group effect, CI, testing, and denominators
Conditions for verification
Group changes, between-group effect, CI, testing, 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
Superior weight loss versus another healthful diet
N07 · Are seventy-four-week follow-up, attrition, ITT, and missing-data details directly verified?
Required materials and conditions
Group follow-up, analysis populations, reasons for missing data, sensitivity, and actual exposure
Conditions for verification
Group follow-up, analysis populations, reasons for missing data, sensitivity, and actual 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
Superior weight loss versus another healthful diet
N08 · What were NEW Soul's actual population and application boundaries?
Required materials and conditions
Original materials on recruitment, baseline status, group denominators, and existing diet
Conditions for verification
Original materials on recruitment, baseline status, group denominators, and existing diet
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
Superior weight loss versus another healthful diet
N09 · What were the actual vegan and low-fat omnivorous soul food diets compared in NEW Soul?
Required materials and conditions
Composition, exposure, education, support, and accompanying management for the two composite diets
Conditions for verification
Composition, exposure, education, support, and accompanying management for the two composite diets
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
Superior weight loss versus another healthful diet
N10 · Is NEW Soul's twelve-month primary weight result preserved as recorded?
Required materials and conditions
Primary outcome, group changes, original between-group effect, CI, and testing
Conditions for verification
Primary outcome, group changes, original between-group 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
Superior weight loss versus another healthful diet
N11 · Are NEW Soul's long-term follow-up, denominators, and missing-data details directly presented?
Required materials and conditions
Records of allocation, twelve-month observations, ITT, attrition, missing data, and sensitivity
Conditions for verification
Records of allocation, twelve-month observations, ITT, attrition, missing data, and sensitivity
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
Superior weight loss versus another healthful diet
N12 · Are nonsignificant P values in active comparisons distinguished from limits on superiority and equivalence?
Required materials and conditions
Effect, CI, importance, and prespecified superiority or equivalence plans
Conditions for verification
Effect, CI, importance, and prespecified superiority or equivalence 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
Superior weight loss versus another healthful diet
N13 · Does the direct-evidence gap remain for an active control with matching population, duration, and support?
Required materials and conditions
Direct materials with an active control, population, and duration matching the original sixteen-week question
Conditions for verification
Direct materials with an active control, population, and duration matching the original sixteen-week question
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
Superior weight loss versus another healthful diet
N14 · Are the large no-change effect and active comparisons preserved separately?
Required materials and conditions
Effect, interval, testing, time point, and denominators for each comparison
Conditions for verification
Effect, interval, testing, time point, and denominators for each comparison
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
Superior weight loss versus another healthful diet
N15 · Are common education, attention, and calorie conditions in the sixteen-week trial distinguished from active comparisons?
Required materials and conditions
Original group materials on education, contact, support, actual calories, and exposure
Conditions for verification
Original group materials on education, contact, support, actual calories, 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
Superior weight loss versus another healthful diet
N16 · What was the original scope of open dietary allocation, masking, and measurement procedures?
Required materials and conditions
Original trial-specific materials on allocation concealment, masking, assessors, and analysts
Conditions for verification
Original trial-specific materials on allocation concealment, masking, assessors, and analysts
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
Superior weight loss versus another healthful diet
N17 · Are prespecified endpoint hierarchies, multiple outcomes, and testing plans separated by trial?
Required materials and conditions
Trial-specific registration, protocol, SAP, multiplicity, and change records
Conditions for verification
Trial-specific registration, protocol, SAP, multiplicity, and change records
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
Superior weight loss versus another healthful diet
N18 · Are results for weight, body composition, lipids, insulin, and mechanisms separated?
Required materials and conditions
Actual measurements, effects, denominators, and prespecified plans for each measure
Conditions for verification
Actual measurements, effects, denominators, and prespecified plans for each measure
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
Superior weight loss versus another healthful diet
N19 · Were results kept from being extended to long-term maintenance, disease, death, or diabetes treatment?
Required materials and conditions
Long-term direct materials separated by endpoint, population, and duration
Conditions for verification
Long-term direct materials separated by endpoint, 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
Superior weight loss versus another healthful diet
N20 · Are shared bibliography, trials, populations, and sibling sheets preserved?
Required materials and conditions
Study-family connections among reports, original trials, the same populations, endpoints, and time points
Conditions for verification
Study-family connections among reports, original trials, the same populations, endpoints, 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
Superior weight loss versus another healthful diet
N21 · Are PCRM, public funding, and authors who were advocacy-organization officers preserved for the sixteen-week trial?
Required materials and conditions
Records of each funder, organizational affiliation, provision, analysis, and writing role
Conditions for verification
Records of each funder, organizational affiliation, provision, analysis, and writing role
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
Superior weight loss versus another healthful diet
N22 · Are gaps in support, provision, authors, and external analysis kept separate for active-comparison trials?
Required materials and conditions
Trial-specific records of monetary support, products, affiliated authors, and external analysis roles
Conditions for verification
Trial-specific records of monetary support, products, affiliated authors, and external analysis roles
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
Superior weight loss versus another healthful diet
N23 · Are there direct comparative safety materials between active controls?
Required materials and conditions
Group harm definitions, collection, events, exposure, denominators, and plans
Conditions for verification
Group harm definitions, collection, events, exposure, denominators, and 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
Superior weight loss versus another healthful diet
N24 · Are gaps in long-term exposure, rare harms, and discontinuation retained?
Required materials and conditions
Actual exposure, discontinuation, serious events, and long-term follow-up by duration
Conditions for verification
Actual exposure, discontinuation, serious events, and long-term follow-up by 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
Superior weight loss versus another healthful diet
N25 · Are special populations, concomitant treatment, replication of harms, and application scope distinguished?
Required materials and conditions
Population-specific direct comparisons, harms, concomitant treatment, and independent-report relationships
Conditions for verification
Population-specific direct comparisons, harms, concomitant treatment, and independent-report relationships
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
Superior weight loss versus another healthful diet
N26 · Is actual access to external papers, registrations, protocols, and SAPs recorded separately?
Required materials and conditions
Original links, identifiers, stored summaries, and actual access records for each material
Conditions for verification
Original links, identifiers, stored summaries, and actual access records for each material
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
Superior weight loss versus another healthful diet
N27 · Are original dates, Korean and English text, corrections, axes, empty values, and subclaim D preserved?
Required materials and conditions
Separate preservation of the full parent stored summary, selected record, languages, and historical values
Conditions for verification
Separate preservation of the full parent stored summary, selected record, languages, and historical values
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
Superior weight loss versus another healthful diet
N28 · Are original content-review status, existing candidate history, and production completion separated?
Required materials and conditions
Records of historical candidate values and current production and review status
Conditions for verification
Records of historical candidate values and current 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
Superior weight loss versus another healthful diet
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 superiority claim against active healthy diets and the parent's no-change effect separated?

Current findings
The original subclaim is ‘Superior weight loss versus another healthful diet’, with original grade D and a note of 74-week diabetes-diet trial P=0.25. The parent is C, 54, Caution.
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. Absent subclaim score, status, and assessment axes are not filled with parent values. Null effects across all other healthy diets are not newly certified.
Reason for missing information
Absent subclaim score, status, and assessment axes are not filled with parent values. Null effects across all other healthy diets are not newly certified.
Required materials and conditions
Separate records of the selected wording, grade, note, and parent comparison
Materials to obtain first
Absent subclaim score, status, and assessment axes are not filled with parent values. Null effects across all other healthy diets are not newly certified.
Further research
If additional materials are provided, distinguish and connect results matched to comparator, population, and duration.
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 comparison
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
Superior weight loss versus another healthful diet

Related sources R02 R03

N02 · Which diets were actually meant by the comparator ‘another healthful diet’?

Current findings
The original active controls were a conventional diabetes diet over 74 weeks and NEW Soul's low-fat omnivorous soul food 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. All other healthy diets are not treated as one identical comparator. Detailed composition, exposure, and education for each diet remain unread.
Reason for missing information
All other healthy diets are not treated as one identical comparator. Detailed composition, exposure, and education for each diet remain unread.
Required materials and conditions
Composition, education, exposure, support, and denominators for a specific active diet
Materials to obtain first
All other healthy diets are not treated as one identical comparator. Detailed composition, exposure, and education for each diet remain unread.
Further research
Obtain original descriptions, common management, and actual intake materials for each active diet.
Remaining uncertainty
Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Composition, education, exposure, support, and denominators for a specific active diet
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
Superior weight loss versus another healthful diet

Related sources R02 R03

N03 · Was the actual control in the sixteen-week trial an active healthy diet?

Current findings
The 16-week trial of 244 participants compared 122 assigned to a vegan diet with 122 assigned to 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. The direct −5.9kg result does not fill the gap in superiority over another healthy diet in the same population at sixteen weeks.
Reason for missing information
The direct −5.9kg result does not fill the gap in superiority over another healthy diet in the same population at sixteen weeks.
Required materials and conditions
Identity of the control and direct comparison in the relevant sixteen-week trial
Materials to obtain first
The direct −5.9kg result does not fill the gap in superiority over another healthy diet in the same population at sixteen weeks.
Further research
If materials on a specific active healthy-diet control in the same population and duration 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
Identity of the control and direct comparison in the relevant sixteen-week 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
Superior weight loss versus another healthful diet

Related sources R01

N04 · What were the population and denominators for the seventy-four-week diabetes-diet comparison?

Current findings
The 74-week trial is recorded as randomizing 99 participants with type 2 diabetes.
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 the same population as general overweight adults. Eligibility, group allocation and analysis, baseline weight, and treatment details remain unread.
Reason for missing information
This is not transferred to the same population as general overweight adults. Eligibility, group allocation and analysis, baseline weight, and treatment details remain unread.
Required materials and conditions
Type 2 diabetes population, eligibility, and group allocation and analysis denominators
Materials to obtain first
This is not transferred to the same population as general overweight adults. Eligibility, group allocation and analysis, baseline weight, and treatment details remain unread.
Further research
Obtain original eligibility, baseline status, group denominators, and concomitant-treatment tables.
Remaining uncertainty
Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Type 2 diabetes population, eligibility, and group allocation and 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
Superior weight loss versus another healthful diet

Related sources R02

N05 · What were the composite components and accompanying management of the seventy-four-week intervention and control?

Current findings
The original study design was a randomized trial of a low-fat vegan diet versus a conventional diabetes 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. Calories, nutritional composition, attention, support, and medication changes are not newly assumed equal between groups. No dietary or medication instructions are created.
Reason for missing information
Calories, nutritional composition, attention, support, and medication changes are not newly assumed equal between groups. No dietary or medication instructions are created.
Required materials and conditions
Original records of low-fat vegan and conventional diabetes diets, education, and concomitant treatment
Materials to obtain first
Calories, nutritional composition, attention, support, and medication changes are not newly assumed equal between groups. No dietary or medication instructions are created.
Further research
Obtain records of each composite diet's composition, actual intake, contact, and concomitant treatment.
Remaining uncertainty
Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original records of low-fat vegan and conventional diabetes diets, education, and concomitant 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
Superior weight loss versus another healthful diet

Related sources R02

N06 · Are the seventy-four-week weight results and gaps in the between-group effect preserved?

Current findings
At 74 weeks, weight changes were −4.4kg with the vegan diet versus −3.0kg with a conventional diabetes diet, between-group P=0.25.
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 mean difference, CI, quantitative response, or NNT is calculated. The original between-group effect, CI, analysis model, and denominators are absent from the summary.
Reason for missing information
No new mean difference, CI, quantitative response, or NNT is calculated. The original between-group effect, CI, analysis model, and denominators are absent from the summary.
Required materials and conditions
Group changes, between-group effect, CI, testing, and denominators
Materials to obtain first
No new mean difference, CI, quantitative response, or NNT is calculated. The original between-group effect, CI, analysis model, and denominators are absent from the summary.
Further research
Obtain the original effect, interval, model, denominators, and weight-measurement methods.
Remaining uncertainty
Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Group changes, between-group effect, CI, testing, 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
Superior weight loss versus another healthful diet

Related sources R02

N07 · Are seventy-four-week follow-up, attrition, ITT, and missing-data details directly verified?

Current findings
The 74-week duration and 99 randomized participants are preserved.
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. Wording about 222 completers, repeated measures, and ITT including all participants concerns the sixteen-week trial and is not transferred to seventy-four weeks.
Reason for missing information
Wording about 222 completers, repeated measures, and ITT including all participants concerns the sixteen-week trial and is not transferred to seventy-four weeks.
Required materials and conditions
Group follow-up, analysis populations, reasons for missing data, sensitivity, and actual exposure
Materials to obtain first
Wording about 222 completers, repeated measures, and ITT including all participants concerns the sixteen-week trial and is not transferred to seventy-four weeks.
Further research
Obtain original participant flow, missing-data handling, analysis populations, and adherence materials for the seventy-four-week trial.
Remaining uncertainty
Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Group follow-up, analysis populations, reasons for missing data, sensitivity, and actual 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
Superior weight loss versus another healthful diet

Related sources R02

N08 · What were NEW Soul's actual population and application boundaries?

Current findings
The NEW Soul bibliography specifies African Americans and records 159 randomized 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. Detailed eligibility, including age, BMI, and comorbidities, remains unread. Results are not newly extended to all overweight adults or all regions.
Reason for missing information
Detailed eligibility, including age, BMI, and comorbidities, remains unread. Results are not newly extended to all overweight adults or all regions.
Required materials and conditions
Original materials on recruitment, baseline status, group denominators, and existing diet
Materials to obtain first
Detailed eligibility, including age, BMI, and comorbidities, remains unread. Results are not newly extended to all overweight adults or all regions.
Further research
Obtain original recruitment, eligibility, baseline status, and group denominators.
Remaining uncertainty
Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original materials on recruitment, baseline status, group denominators, and existing diet
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
Superior weight loss versus another healthful diet

Related sources R03

N09 · What were the actual vegan and low-fat omnivorous soul food diets compared in NEW Soul?

Current findings
The original study design was a randomized active-control trial of vegan versus low-fat omnivorous soul food diets.
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 are not generalized to all vegan diets or all omnivorous healthy diets, and the sixteen-week diet composition is not copied unchanged.
Reason for missing information
Results are not generalized to all vegan diets or all omnivorous healthy diets, and the sixteen-week diet composition is not copied unchanged.
Required materials and conditions
Composition, exposure, education, support, and accompanying management for the two composite diets
Materials to obtain first
Results are not generalized to all vegan diets or all omnivorous healthy diets, and the sixteen-week diet composition is not copied unchanged.
Further research
Obtain NEW Soul's original diet composition, contact, support, 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
Composition, exposure, education, support, and accompanying management for the two composite diets
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
Superior weight loss versus another healthful diet

Related sources R03

N10 · Is NEW Soul's twelve-month primary weight result preserved as recorded?

Current findings
At 12 months, primary weight changes were −2.39kg with the vegan diet versus −2.03kg with the low-fat omnivorous diet, between-group P=.64.
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 mean difference, response count, CI, or equivalence verdict is created. Group analysis denominators, original CI, and model remain unread.
Reason for missing information
No new mean difference, response count, CI, or equivalence verdict is created. Group analysis denominators, original CI, and model remain unread.
Required materials and conditions
Primary outcome, group changes, original between-group effect, CI, and testing
Materials to obtain first
No new mean difference, response count, CI, or equivalence verdict is created. Group analysis denominators, original CI, and model remain unread.
Further research
Obtain the original primary-outcome plan, group denominators, effect, CI, and measurement materials.
Remaining uncertainty
Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Primary outcome, group changes, original between-group 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
Superior weight loss versus another healthful diet

Related sources R03

N11 · Are NEW Soul's long-term follow-up, denominators, and missing-data details directly presented?

Current findings
The original materials record 159 randomized participants and 12-month results.
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. The 159 randomized participants are not confirmed as the analysis denominator for every twelve-month result, and the sixteen-week 91.0% completion rate is not transferred.
Reason for missing information
The 159 randomized participants are not confirmed as the analysis denominator for every twelve-month result, and the sixteen-week 91.0% completion rate is not transferred.
Required materials and conditions
Records of allocation, twelve-month observations, ITT, attrition, missing data, and sensitivity
Materials to obtain first
The 159 randomized participants are not confirmed as the analysis denominator for every twelve-month result, and the sixteen-week 91.0% completion rate is not transferred.
Further research
Obtain original participant flow, group missing data, ITT, analysis populations, and adherence materials.
Remaining uncertainty
Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Records of allocation, twelve-month observations, ITT, attrition, missing data, and sensitivity
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
Superior weight loss versus another healthful diet

Related sources R03

N12 · Are nonsignificant P values in active comparisons distinguished from limits on superiority and equivalence?

Current findings
The stored summary records that 74-week P=0.25 and NEW Soul P=.64 did not show superiority over active controls.
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. Without CI, thresholds, or an equivalence design, zero for every difference or equivalence with all healthy diets is not newly confirmed.
Reason for missing information
Without CI, thresholds, or an equivalence design, zero for every difference or equivalence with all healthy diets is not newly confirmed.
Required materials and conditions
Effect, CI, importance, and prespecified superiority or equivalence plans
Materials to obtain first
Without CI, thresholds, or an equivalence design, zero for every difference or equivalence with all healthy diets is not newly confirmed.
Further research
Connect the relevant comparison scope when the original CI, testing plan, and importance threshold are provided.
Remaining uncertainty
Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Effect, CI, importance, and prespecified superiority or equivalence 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
Superior weight loss versus another healthful diet

Related sources R02 R03

N13 · Does the direct-evidence gap remain for an active control with matching population, duration, and support?

Current findings
The current active comparisons concern type 2 diabetes at 74 weeks and NEW Soul at 12 months; their populations, durations, and controls differ from the 16-week no-change trial.
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. Existing active comparisons are not erased as nonexistent, but a direct comparison matching the original sixteen-week conditions is not newly confirmed.
Reason for missing information
Existing active comparisons are not erased as nonexistent, but a direct comparison matching the original sixteen-week conditions is not newly confirmed.
Required materials and conditions
Direct materials with an active control, population, and duration matching the original sixteen-week question
Materials to obtain first
Existing active comparisons are not erased as nonexistent, but a direct comparison matching the original sixteen-week conditions is not newly confirmed.
Further research
Direct materials for a specific active healthy-diet comparison with matched population, duration, education, and attention are needed.
Remaining uncertainty
Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Direct materials with an active control, population, and duration matching the original sixteen-week question
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
Superior weight loss versus another healthful diet

Related sources R01 R02 R03

N14 · Are the large no-change effect and active comparisons preserved separately?

Current findings
The original 16-week values are retained: vegan −6.4kg versus no change −0.5kg, treatment effect −5.9kg (95% CI −6.8~−5.0), group×time P<0.001.
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. These are not transferred to a mean difference or CI versus an active healthy diet. The original verdict that sixteen-week E+ was unchanged because the comparator differed is retained.
Reason for missing information
These are not transferred to a mean difference or CI versus an active healthy diet. The original verdict that sixteen-week E+ was unchanged because the comparator differed is retained.
Required materials and conditions
Effect, interval, testing, time point, and denominators for each comparison
Materials to obtain first
These are not transferred to a mean difference or CI versus an active healthy diet. The original verdict that sixteen-week E+ was unchanged because the comparator differed is retained.
Further research
Connect each comparison's original model, effect, interval, population, and duration separately.
Remaining uncertainty
Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Effect, interval, testing, time point, and denominators for each comparison
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
Superior weight loss versus another healthful diet

Related sources R01

N15 · Are common education, attention, and calorie conditions in the sixteen-week trial distinguished from active comparisons?

Current findings
The 16-week vegan group received weekly classes and support; food and supplements were not provided. Ad libitum 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. Education differences in the sixteen-week trial are not ignored or copied as identical conditions across all active comparisons. Equal actual calories or an independent mechanism is not newly asserted.
Reason for missing information
Education differences in the sixteen-week trial are not ignored or copied as identical conditions across all active comparisons. Equal actual calories or an independent mechanism is not newly asserted.
Required materials and conditions
Original group materials on education, contact, support, actual calories, and exposure
Materials to obtain first
Education differences in the sixteen-week trial are not ignored or copied as identical conditions across all active comparisons. Equal actual calories or an independent mechanism is not newly asserted.
Further research
Obtain education, attention, calories, intake, and accompanying-exposure materials for each trial separately.
Remaining uncertainty
Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original group materials on education, contact, support, actual calories, 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
Superior weight loss versus another healthful diet

Related sources R01 R02 R03

N16 · What was the original scope of open dietary allocation, masking, and measurement procedures?

Current findings
The stored summary records the 16-week trial as open-label and parallel-group, with infeasible participant masking and 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. These details are not transferred to allocation and measurement procedures in the seventy-four-week trial or NEW Soul. The parent's B0 is historical.
Reason for missing information
These details are not transferred to allocation and measurement procedures in the seventy-four-week trial or NEW Soul. The parent's B0 is historical.
Required materials and conditions
Original trial-specific materials on allocation concealment, masking, assessors, and analysts
Materials to obtain first
These details are not transferred to allocation and measurement procedures in the seventy-four-week trial or NEW Soul. The parent's B0 is historical.
Further research
Obtain original allocation, concealment, measurement, and analysis procedures for each active-comparison trial.
Remaining uncertainty
Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original trial-specific materials on allocation concealment, masking, assessors, and analysts
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
Superior weight loss versus another healthful diet

Related sources R01 R02 R03

N17 · Are prespecified endpoint hierarchies, multiple outcomes, and testing plans separated by trial?

Current findings
The record quotes multiple primary outcomes including weight for the 16-week trial and primary 12-month weight for NEW Soul.
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 seventy-four-week weight hierarchy or multiplicity adjustment in active comparisons is not invented. The sixteen-week coprimary split is preserved as its original false value.
Reason for missing information
The seventy-four-week weight hierarchy or multiplicity adjustment in active comparisons is not invented. The sixteen-week coprimary split is preserved as its original false value.
Required materials and conditions
Trial-specific registration, protocol, SAP, multiplicity, and change records
Materials to obtain first
The seventy-four-week weight hierarchy or multiplicity adjustment in active comparisons is not invented. The sixteen-week coprimary split is preserved as its original false value.
Further research
Obtain each trial's original registration, protocol, SAP, change history, and outcome hierarchy.
Remaining uncertainty
Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Trial-specific registration, protocol, SAP, multiplicity, and change records
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
Superior weight loss versus another healthful diet

Related sources R01 R02 R03

N18 · Are results for weight, body composition, lipids, insulin, and mechanisms separated?

Current findings
The original 16-week bibliography includes insulin sensitivity, metabolism, and intracellular lipids; NEW Soul's bibliography includes weight and lipids.
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. Original weight values are not copied as effects on other measures, body composition, or mechanisms. Those numerical results are not invented in this stored summary.
Reason for missing information
Original weight values are not copied as effects on other measures, body composition, or mechanisms. Those numerical results are not invented in this stored summary.
Required materials and conditions
Actual measurements, effects, denominators, and prespecified plans for each measure
Materials to obtain first
Original weight values are not copied as effects on other measures, body composition, or mechanisms. Those numerical results are not invented in this stored summary.
Further research
Obtain original measurements, effect, CI, and denominators for each measure separately.
Remaining uncertainty
Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Actual measurements, effects, denominators, and prespecified plans for each measure
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
Superior weight loss versus another healthful diet

Related sources R01 R03

N19 · Were results kept from being extended to long-term maintenance, disease, death, or diabetes treatment?

Current findings
The parent explicitly identifies long-term maintenance, clinical events, and superiority over another healthy diet as separate questions. Weight results at 74 weeks and 12 months concern those durations.
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. Some longer durations are not extended to benefits or null effects for all long-term maintenance, disease, death, or treatment outcomes.
Reason for missing information
Some longer durations are not extended to benefits or null effects for all long-term maintenance, disease, death, or treatment outcomes.
Required materials and conditions
Long-term direct materials separated by endpoint, population, and duration
Materials to obtain first
Some longer durations are not extended to benefits or null effects for all long-term maintenance, disease, death, or treatment outcomes.
Further research
Connect direct follow-up, effects, and denominators for each long-term question separately.
Remaining uncertainty
Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Long-term direct materials separated by endpoint, 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
Superior weight loss versus another healthful diet

Related sources R01 R02 R03

N20 · Are shared bibliography, trials, populations, and sibling sheets preserved?

Current findings
The two subclaim sheets share three reports and registration identifiers. The original 16-week single-trial, R1, and mixed-independence wording belongs to parent history.
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. Two sheets, multiple endpoints, and long-term measurements are not added up as unique trials, total participants, or new independent replication.
Reason for missing information
Two sheets, multiple endpoints, and long-term measurements are not added up as unique trials, total participants, or new independent replication.
Required materials and conditions
Study-family connections among reports, original trials, the same populations, endpoints, and time points
Materials to obtain first
Two sheets, multiple endpoints, and long-term measurements are not added up as unique trials, total participants, or new independent replication.
Further research
Connect additional reports to existing identifiers without confirming a final independent count.
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 reports, original trials, the same populations, endpoints, 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
Superior weight loss versus another healthful diet

Related sources R01 R02 R03

N21 · Are PCRM, public funding, and authors who were advocacy-organization officers preserved for the sixteen-week trial?

Current findings
PCRM, Yale, and NIH funding and participation by PCRM clinical-research director Kahleova and president Barnard are preserved. 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. Public support alone is not described as confirming independence, and organizational officers are not newly classified as pharmaceutical-manufacturer employees.
Reason for missing information
Public support alone is not described as confirming independence, and organizational officers are not newly classified as pharmaceutical-manufacturer employees.
Required materials and conditions
Records of each funder, organizational affiliation, provision, analysis, and writing role
Materials to obtain first
Public support alone is not described as confirming independence, and organizational officers are not newly classified as pharmaceutical-manufacturer employees.
Further research
Obtain original support, affiliation, design, analysis, writing, and data-access disclosures separately.
Remaining uncertainty
Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Records of each funder, organizational affiliation, provision, analysis, and writing role
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
Superior weight loss versus another healthful diet

Related sources R01

N22 · Are gaps in support, provision, authors, and external analysis kept separate for active-comparison trials?

Current findings
Funding information for the 74-week trial records NIH R01 DK059362 and other support; NEW Soul is recorded as ‘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. No food provision and PCRM disclosures in the sixteen-week trial are not copied to other trials, and vague funding is not filled as absent or public. External analysis services also remain unverified.
Reason for missing information
No food provision and PCRM disclosures in the sixteen-week trial are not copied to other trials, and vague funding is not filled as absent or public. External analysis services also remain unverified.
Required materials and conditions
Trial-specific records of monetary support, products, affiliated authors, and external analysis roles
Materials to obtain first
No food provision and PCRM disclosures in the sixteen-week trial are not copied to other trials, and vague funding is not filled as absent or public. External analysis services also remain unverified.
Further research
Obtain original support, provision, affiliation, and analysis disclosures for each active-comparison trial.
Remaining uncertainty
Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Trial-specific records of monetary support, products, affiliated authors, and external analysis roles
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
Superior weight loss versus another healthful diet

Related sources R02 R03

N23 · Are there direct comparative safety materials between active controls?

Current findings
The original materials record that the 16-week trial did not report a prespecified primary safety outcome or between-group adverse-event table.
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. This non-reporting wording is not copied to all harm results in the two active-comparison trials. Detailed harm tables for the selected comparisons remain unread.
Reason for missing information
This non-reporting wording is not copied to all harm results in the two active-comparison trials. Detailed harm tables for the selected comparisons remain unread.
Required materials and conditions
Group harm definitions, collection, events, exposure, denominators, and plans
Materials to obtain first
This non-reporting wording is not copied to all harm results in the two active-comparison trials. Detailed harm tables for the selected comparisons remain unread.
Further research
Obtain original harm collection, group events, exposure, denominators, and discontinuation materials for each active-comparison trial.
Remaining uncertainty
Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Group harm definitions, collection, events, exposure, denominators, and 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
Superior weight loss versus another healthful diet

Related sources R01 R02 R03

N24 · Are gaps in long-term exposure, rare harms, and discontinuation retained?

Current findings
The original active-comparison durations were 74 weeks and 12 months. The parent's safety status is preserved as Caution.
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. Duration alone does not confirm long-term safety. Counts, rates, severity, or CIs for nutritional harms absent from the original text are not generated.
Reason for missing information
Duration alone does not confirm long-term safety. Counts, rates, severity, or CIs for nutritional harms absent from the original text are not generated.
Required materials and conditions
Actual exposure, discontinuation, serious events, and long-term follow-up by duration
Materials to obtain first
Duration alone does not confirm long-term safety. Counts, rates, severity, or CIs for nutritional harms absent from the original text are not generated.
Further research
Original group harm and discontinuation materials with actual exposure and sufficient duration for each diet are needed.
Remaining uncertainty
Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Actual exposure, discontinuation, serious events, and long-term follow-up by 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
Superior weight loss versus another healthful diet

Related sources R02 R03

N25 · Are special populations, concomitant treatment, replication of harms, and application scope distinguished?

Current findings
The original safety context includes pregnancy, breastfeeding, eating disorders, and people undergoing 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. No new instructions for diet or treatment changes are created for them, and direct effects or replication of harms in those populations are not confirmed.
Reason for missing information
No new instructions for diet or treatment changes are created for them, and direct effects or replication of harms in those populations are not confirmed.
Required materials and conditions
Population-specific direct comparisons, harms, concomitant treatment, and independent-report relationships
Materials to obtain first
No new instructions for diet or treatment changes are created for them, and direct effects or replication of harms in those populations are not confirmed.
Further research
If direct materials for those populations are provided, connect original trials, exposure, and denominators 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, harms, concomitant treatment, and independent-report relationships
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
Superior weight loss versus another healthful diet

Related sources R01 R02 R03

N26 · Is actual access to external papers, registrations, protocols, and SAPs recorded separately?

Current findings
The three PubMed URLs and NCT02939638, NCT00276939, and NCT03354377 are connected as recorded, and the summary was read for production.
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 constructed from an identifier; external abstracts, full texts, registrations, protocols, and SAPs remain unread. No separate external-link checks were performed.
Reason for missing information
No new URL is constructed from an identifier; external abstracts, full texts, registrations, protocols, and SAPs remain unread. No separate external-link checks were performed.
Required materials and conditions
Original links, identifiers, stored summaries, and actual access records for each material
Materials to obtain first
No new URL is constructed from an identifier; external abstracts, full texts, registrations, protocols, and SAPs remain unread. No separate external-link checks were performed.
Further research
Connect only materials obtained by the user, with separate type and access status.
Remaining uncertainty
Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original links, identifiers, stored summaries, and actual access records for each material
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
Superior weight loss versus another healthful diet

Related sources R01 R02 R03

N27 · Are original dates, Korean and English text, corrections, axes, empty values, and subclaim D preserved?

Current findings
The reference date 2026-08-26, an empty corrections array, an empty deliberation string, Korean and English text, parent C54, Caution, original assessment axes, and subclaim D are preserved.
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. Absent subclaim values are not filled with the parent score. Historical cross-checking is not described as completed review here.
Reason for missing information
Absent subclaim values are not filled with the parent score. Historical cross-checking is not described as completed review here.
Required materials and conditions
Separate preservation of the full parent stored summary, selected record, languages, and historical values
Materials to obtain first
Absent subclaim values are not filled with the parent score. Historical cross-checking is not described as completed review here.
Further research
Connect new materials or decisions through preservation of original text and separate events.
Remaining uncertainty
Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Separate preservation of the full parent stored summary, selected record, languages, and historical values
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
Superior weight loss versus another healthful diet

Related sources R01 R02 R03

N28 · Are original content-review status, existing candidate history, and production completion separated?

Current findings
Existing candidate pending and production-eligibility markers and boundary requirements are preserved as history, while the current marker indicates incomplete original content review. Active pending and completion flags for model, content, and boundary review are false.
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; additional 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; additional units are 0 and the final independent count is not recorded.
Required materials and conditions
Records of historical candidate values and current production and review status
Materials to obtain first
There is no new main claim, split, or independent certification; additional 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
Records of historical candidate values and current 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
Superior weight loss versus another healthful diet

Related sources R01 R02 R03