Test beverage containing hot-water extract of sun-dried lotus leaves × Reduction of whole-body fat percentage in adults with overweight

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Met	Full text not readStored summary read	N01 · Evidence conditionWhich lotus-leaf preparation, population and body-fat comparison are being checked?Required (selected 12-week whole-body fat-percentage comparison)	The question concerns whole-body fat percentage at 12 weeks in adults with overweight given a 400 mL beverage containing 1 or 2 g/day hot-water extract of sun-dried lotus leaves. The original subclaim list is empty. S1	Checking this boundary does not confirm efficacy or revalidate the legacy grade.	Plant part, extraction, beverage, population, whole-body fat percentage, 0 g comparator and time	Compare subsequent material with the formulation, population, comparator, outcome and time.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionAre eligibility criteria, post hoc selection and baseline characteristics of the registered and analyzed populations verified?Required (selected 12-week whole-body fat-percentage comparison)	The retained record describes 95 registered Chinese adults aged 40–60 with overweight and analysis of 60 completers with BMI24–28. S1	Baseline balance, complete eligibility criteria, the basis for post hoc criteria and representativeness cannot be established from this record alone.	Age, BMI, diagnosis, inclusion/exclusion, baseline tables and post hoc selection process	Obtain baseline tables by arm, selection rules, timing of application and reasons for exclusion.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionAre the plant part, extraction, major constituents and batch-specific assays/manufacturing specifications verified?Required (selected 12-week whole-body fat-percentage comparison)	Hot-water extract of sun-dried leaves is recorded, with quercetin-3-O-glucuronide and quercetin as major constituents. S1	Original material for actual batches, complete constituent assays and manufacturing quality has not been read in this work.	Plant species, part, drying, extraction, constituents, manufacturing batches and product material	When product specifications, batch and constituent-assay material become available, compare the plant part, processing and formulation with the actual trial intervention.
4	Met	Full text not readStored summary read	N04 · Evidence conditionWhat are the route, nominal dose and volume of the test beverage?Required (selected 12-week whole-body fat-percentage comparison)	The record describes oral test beverages of 400 mL/day (2 bottles of 200 mL) containing 0, 1 or 2 g; the intervention doses are 1 or 2 g/day. S1	Individual actual consumption and adherence are not inferred from these nominal specifications.	Oral administration,400 mL, 2 bottles of 200 mL and 0/1/2 g beverage specifications	Separately compare actual consumption, adherence, batches and exposure by arm.
5	Met	Full text not readStored summary read	N05 · Evidence conditionWhen were treatment and body-fat assessments performed?Required (selected 12-week whole-body fat-percentage comparison)	Treatment lasted 12 weeks and the original primary endpoint specifies changes in whole-body fat percentage at 6 and 12 weeks. The retained numerical results are at 12 weeks. S1	Detailed 6-week results and persistence beyond 12 weeks are not available in this record.	12-week treatment,6/12-week measurements, completion and follow-up schedule	Obtain time-specific result tables and follow-up after treatment stops.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionHow well are the 0 g control beverage and other conditions matched?Required (selected 12-week whole-body fat-percentage comparison)	The comparator is recorded as the same-format test beverage containing 0 g extract. S1	Detailed taste/appearance matching, shared lifestyle management, concomitant conditions and changes remain unverified.	0 g beverage specifications, appearance/taste, common management and differences between arms	Obtain control ingredients, blinding, common management and treatment changes by arm.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionAre actual allocation, concealment and baseline balance verified?Required (selected 12-week whole-body fat-percentage comparison)	The record describes a randomized 3-arm trial with participant/care-provider blinding and a 0 g beverage comparator. S1	Detailed original material on sequence generation, concealment and baseline balance cannot be checked from the retained summary alone.	3-arm allocation methods, sequence generation, allocation concealment and baseline characteristics by arm	Link methods/allocation material and baseline tables by arm to review the verified scope of sequence generation, concealment and baseline balance.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionCan randomization, discontinuation, analysis and other exclusions be distinguished?Required (selected 12-week whole-body fat-percentage comparison)	The original record distinguishes 95 randomized participants, 22 discontinuations and 60 overweight completers analyzed. Discontinuations by arm were 7/6/9 and analyzed counts 22/22/16; reasons for excluding the other 13 remain unverified. S1	Complete allocation/measurement denominators by arm and reasons for excluding 13 participants cannot currently be verified. Do not count all 13 as discontinuations.	95 randomized, participant flow by arm, 22 discontinuations, 60 analyzed and reasons for 13 additional exclusions	Obtain complete CONSORT flow, randomized/measured/analyzed counts by arm, reasons for exclusion and timing.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionHow does post hoc BMI selection affect the allocation effect and analysis?Required (selected 12-week whole-body fat-percentage comparison)	The record says PubMed’s n=60 is the number of completers meeting post hoc overweight criteria, rather than the randomized denominator. S1	Analytical handling of selection and the allocation effect in all 95 participants remain unverified within this retained scope.	Timing of post hoc selection, selection of completers, retention of randomized groups, exclusions and analysis methods	Obtain prespecified plans, full-arm analyses, exclusion reasons and sensitivity analyses for selection.
10	Unverified	Full text not readStored summary read	N10 · Evidence conditionAre the effect of interest and handling of missingness/discontinuation verified?Required (selected 12-week whole-body fat-percentage comparison)	The original summary distinguishes a post hoc analysis of 60 completers from 95 randomized participants. S1	Missing-data handling, the effect of interest, full-randomized-analysis results and sensitivity cannot be established at the locations read in this work.	ITT/PP, missingness mechanisms, imputation, measurement losses, sensitivity analyses and effect of interest	Obtain the analysis plan, missingness by arm, full-randomized analyses and sensitivity analyses.
11	Unverified	Full text not readStored summary read	N11 · Evidence conditionAre measurement, calibration and assessment procedures for whole-body fat percentage verified?Required (selected 12-week whole-body fat-percentage comparison)	The selected outcome is whole-body fat percentage at 12 weeks; the claim conditions specify changes at 6/12 weeks. S1	Measurement equipment, calibration, environment and assessor procedures cannot be verified in the retained record.	Instrument/method, calibration, measurement environment, assessors, timing and consistency between arms	Obtain original methods, instrument/calibration information, measurement environment and assessment procedures.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionAre participant/care-provider and outcome-assessor/analyst blinding and its maintenance verified?Required (selected 12-week whole-body fat-percentage comparison)	The original design field records participant/care-provider blinding. S1	Outcome-assessor/analyst blinding and checks that blinding was maintained cannot be verified from the retained material alone.	Who was blinded, formulation matching, maintenance of blinding and outcome-assessment procedures	Obtain methods, formulation matching, maintenance of blinding and assessment/analysis procedures.
13	Unverified	Full text not readStored summary read	N13 · Evidence conditionHow are differences in lifestyle management, concurrent treatment and adherence handled?Required (selected 12-week whole-body fat-percentage comparison)	The original claim conditions retain beverage volume, nominal extract doses and duration. S1	Diet/exercise, concomitant medicines, consumption adherence, rescue treatment and their handling by arm remain unverified.	Diet/exercise, concomitant medicines, actual exposure, changes by arm and analytical handling	Obtain common-management arrangements, medication/lifestyle changes, adherence and handling by arm.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionTo which time, sex, dose and unit do the original results belong?Required (selected 12-week whole-body fat-percentage comparison)	Retained 12-week results are men 1 g/day,-2.6 percentage points (P=.019); women 1 g/day,-3.7 percentage points (P=.009); and women 2 g/day,-2.9 percentage points (P=.027). S1	Stratum-specific n, calculation definitions, baseline/final values and whether contrasts are between-group or within-group remain unverified.	12 weeks, whole-body fat percentage, percentage points, sex/dose and final values/changes	Obtain original result tables, time-specific baseline/final values, change definitions and denominators by stratum.
15	Unverified	Full text not readStored summary read	N15 · Evidence conditionWhich comparison do the three reported estimates represent?Required (selected 12-week whole-body fat-percentage comparison)	The original Korean/English record explicitly says whether the three values are between-group differences or within-group changes remains unverified. S1	Without verified actual contrasts and analysis models, the three values do not establish between-group effects or a unified main effect.	Between-group/within-group status, comparator, analysis model, adjustment and estimand for each value	Link arm order, contrast, model and stratum-specific denominators in each result table to distinguish between-group estimates from within-group changes.
16	Unverified	Full text not readStored summary read	N16 · Evidence conditionAre intervals available to interpret uncertainty in the selected contrast?Required (selected 12-week whole-body fat-percentage comparison)	The retained results include P=.019/.009/.027 and a statement that 95% CIs were not reported. S1	Actual CIs, variance, n and contrasts for each stratum were not verified within the material read. Do not extend this to nonreporting throughout the entire paper.	95% CI, variance, denominators by stratum and model for each contrast	Link original result-table contrasts, variance, stratum-specific denominators and reported CIs to assess whether intervals are interpretable. Do not perform new back-calculations.
17	Unverified	Full text not readStored summary read	N17 · Evidence conditionAre a justified importance threshold and the actual contrast/interval for body-fat change verified?Required (selected 12-week whole-body fat-percentage comparison)	The retained record provides sex- and dose-specific body-fat percentages and P values, while a unified main effect/CIs remain unverified. S1	An importance threshold and estimate intervals for comparison have not been verified in this work.	Justified important difference in whole-body fat percentage, population-specific interpretation and intervals	Obtain the basis for importance, patient-relevant outcomes and contrast-specific intervals.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionDo registration timing and original endpoints/analysis plans match the report?Required (selected 12-week whole-body fat-percentage comparison)	NCT04651023 is recorded as posted 11 years after study completion. Weight, body fat, visceral fat, waist and hip were listed as multiple primary outcomes. S1	Registration, protocol and SAP bytes remain unread in this work; complete comparison of prespecified analyses/endpoints and changes remains pending.	NCT04651023, initial/amended registrations, protocol, SAP and endpoints/times	Obtain registration history, prospective protocol/SAP, complete results and reasons for changes.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionHow are sex/dose selection and multiple endpoints handled?Required (selected 12-week whole-body fat-percentage comparison)	The paper selected sex- and dose-specific completer results; retained positive strata are men 1 g, women 1 g and women 2 g. S1	Prespecification, interactions, multiplicity handling and complete results including men 2 g remain unverified.	Prespecified subgroups, n by stratum, interactions, multiple comparisons and complete-arm results	Obtain prespecified analysis plans, all stratum results, interaction estimates and multiplicity handling.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionAre the family relationship of the Ye report/NCT04651023 and other direct independent replications verified?Required (selected 12-week whole-body fat-percentage comparison)	One evidence/citation record retains PMID34852695, DOI10.1080/14786419.2021.2010196 and NCT04651023. The manuscript says independent replication was not verified. S1	No current certification of unique families/participant independence or new literature search was performed. Do not establish 0 independent replications.	PMID/DOI/NCT, study families, independent material and complete results	Obtain study-family tables, registry/report links and independent material addressing the same question.
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionAre sponsorship, beverage supply, author employment, sponsor design/analysis roles and full COI declarations verified?Required (selected 12-week whole-body fat-percentage comparison)	The record describes sponsorship by Shanghai Meiji Health Science and Technology, provision of test beverages and several authors employed in Meiji R&D. S1	Sponsor control of design/analysis and complete author-specific COI details remain unverified.	Funding, product supply, author employment, declared interests and independent design/analysis	Obtain original funding/COI declarations, roles, analytical control and author-specific disclosures.
22	Not applicable	Full text not readStored summary read	N22 · Evidence conditionDoes this question require an optimal dose or persistence after discontinuation?Supplementary; required for optimal-dose or persistence extensions	This checklist concerns 12-week body-fat percentage and does not adopt optimal-dose or maintenance claims. Sex/dose observations are retained in separate rows. S1	Extension effects themselves remain unverified. Do not require every dose/long-term trial as essential to the current narrow question.	Direct dose comparisons, long-term/post-discontinuation follow-up and separate estimates	If an extension is requested, separately design dose-versus-dose comparisons and long-term/post-discontinuation follow-up.
23	Not applicable	Full text not readStored summary read	N23 · Evidence conditionAre body-fat-percentage results being transferred to weight, visceral fat or clinical events?Supplementary; required for extensions to other endpoints or events	The manuscript explicitly says the result cannot be extended to reduced weight/visceral fat or efficacy of ordinary lotus-leaf tea. S1	Confirmation of other endpoints/events is not added as essential to the current body-fat-percentage question. This checklist does not certify those effects.	Separate evidence for selected body-fat percentage versus weight/visceral fat and disease events	If an extension is requested, separately review actual endpoint-specific results and disease events for the same preparation.
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionAre the 60-person/12-week report and event definitions, collection and discontinuation reasons for all exposed participants verified?Supplementary; required for safety claims	The original safety description records no reported test-beverage adverse reactions among the 60 analyzed participants. S1	This does not establish 0 events among all 95 participants, systematic collection or reasons for discontinuation/exclusion. Limitations of a short-term selected sample remain.	60 analyzed, 12 weeks, all exposed participants, event definitions/collection and discontinuation reasons	Obtain all exposed participants by arm, event counts, collection methods and discontinuation reasons.
25	Unverified	Full text not readStored summary read	N25 · Evidence conditionAre direct data available for vulnerable populations, concomitant medicines and long-term or rare harms?Supplementary; required for the corresponding safety extension	The original safety record leaves pregnancy, lactation, allergy, liver/kidney disease and interactions with blood-pressure/glucose medicines unverified. S1	Direct comparisons for these populations/medicines and long-term/rare-harm material have not been verified in this work.	Pregnancy/lactation, allergy, liver/kidney conditions, blood-pressure/glucose medicines and long-term/rare harms	Obtain comparative exposure/event material for those populations and concomitant medicines, and long-term follow-up.
26	Met	Full text not readStored summary read	N26 · Evidence conditionAre material actually read and historical verification narratives distinguished?Required (selected 12-week whole-body fat-percentage comparison)	The material read in this work is the complete current retained JSON. The original review date 2026-09-08 and historical narrative of PMID/NCT/publisher cross-checking are retained. S1	External full text, registration, publisher PDF and SAP remain unread/unacquired in this work. Typed access-level, individual access-date and location fields are absent from the original bibliography.	Retained JSON, original review date, bibliography/access, current date and original locations/SHA	When material is later acquired, record identity, material type, date, access/reading, locations and byte SHA.
27	Met	Full text not readStored summary read	N27 · Evidence conditionAre the legacy grade, axes, corrections and under-review status preserved?Required (selected 12-week whole-body fat-percentage comparison)	The original C 46,S/R1/I0/EX/B2/CX, grade-revalidation flag false, legacy-grade-under-review status and 2026-09-14 correction are retained. S1	The legacy grade remains under review. This conversion is not a final reassessment or calculation of values/CIs.	C 46, EX/CX, original/previous axes, corrections and grade-revalidation flag false	If reassessment is later requested, preserve the original, previous values, new evidence and change decision as a separate event.
28	Met	Full text not readStored summary read	N28 · Evidence conditionAre subsequent evidence, condition changes and verdict changes linked as separate events?Required (selected 12-week whole-body fat-percentage comparison)	Current limitations in denominator selection, individual contrasts/CIs, retrospective registration, multiple analyses, industry funding and safety, and the original correction, are retained. Subsequent checks are linked to each row. S1	New evidence, reassessment and public deployment were not performed in the retained case record.	Original results, denominators/contrasts/CIs, registration/SAP, measurement/harms, condition versions and previous values	Record identity, reading and locations; review affected rows, and freeze a revised condition version before application.

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28 itemsWhat the statuses mean

Assessment scope

Stored-material review date: 2026-10-05
Original evidence review date: 2026-09-08
Scope actually checked: Retained Korean/English summaries and case-specific condition/application records. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted.
Population: Chinese adults aged 40–60 with overweight; 95 with BMI 23–30 were registered, while the paper analyzed 60 completers with BMI 24–28
Ingredient, formulation and route: Test beverage 400 mL per 1 day (2 bottles of 200 mL) containing 0, 1, or 2 g extract
Dose: Lotus leaf hot-water extract 1 or 2 g/day
Comparator: Same-format test beverage containing 0 g extract
Measured outcome: Change in whole-body fat percentage at weeks 6 and 12
Duration: 12 weeks
Questions outside this scope: The scope is whole-body fat percentage after 12 weeks of a test beverage containing 1 or 2 g/day hot-water extract of sun-dried lotus leaves. Do not extend it to lotus-leaf tea, capsules, food, other plant parts, weight, visceral fat or disease prevention.; Distinguish 95 randomized participants,22 discontinuations and 60 analyzed participants. Reasons for excluding the other 13 remain unverified; they are not all counted as discontinuations.; Whether the sex- and dose-specific values are between-group contrasts or within-group changes, and their 95% CIs, remain unverified. Do not newly calculate or establish a unified main effect, optimal dose or persistence.; Retain the original Caution label and limits of the short-term selected sample. Unverified vulnerable populations, concomitant medicines and long-term or rare harms do not establish safety or personal dosing 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.

S1 · Ye report of lotus-leaf hot-water extract and whole-body fat percentage

PubMed

Material type: Retained bibliographic and linked summary of a randomized 3-arm trial with a 0 g control beverage
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Findings recorded in the stored summary: Reported subgroup changes: men, 1 g/day, -2.6 percentage points (P=.019); women, 1 g/day, -3.7 (P=.009); women, 2 g/day, -2.9 (P=.027). No 95% CI reported; the contrast underlying these changes is unverified in the retained record.
Record level: Retained sex- and dose-specific results for whole-body fat percentage at 12 weeks. Actual contrasts, stratum-specific denominators, variance, intervals and measurement method remain unverified. This is not new checking of external full text, registration or prespecified plans.
Study overlap and independent replication: The link between report S1 and the retained registration is shown. The PMID, DOI and NCT are not counted as separate independent replications. Total unique trial and participant counts and other direct independent replications remain unverified.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Retained bilingual research/bibliographic summaries and historical review record	Retained copy acquired; summary read	Retained copy acquired; summary read	Stored existing review summary read	Actual values and locations in the retained summary were read. Distinguish this from external clinical full-text bytes. Historical manuscript descriptions of paper, registry and publisher cross-checking are historical records. They do not establish current actual reading of external bibliography, abstracts, full text or registration. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted.
PubMed bibliography/abstract entry point	Material type recorded; current public availability unverified	External access not attempted; not acquired	Not read	An entry-point link from the retained bibliography. Current URL response and bibliographic/abstract contents were not checked; access, acquisition and reading were not attempted. Historical manuscript descriptions of paper, registry and publisher cross-checking are historical records. They do not establish current actual reading of external bibliography, abstracts, full text or registration. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted.
Full paper: direct URL and current access scope unverified	Material type recorded; current public availability unverified	External access not attempted; not acquired	Not read	Direct full-text URL and current availability scope remain unverified. Distinguish the bibliographic entry point from full text; external access, acquisition and reading were not attempted. Historical manuscript descriptions of paper, registry and publisher cross-checking are historical records. They do not establish current actual reading of external bibliography, abstracts, full text or registration. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted.
Original trial-registration material NCT04651023	Material type recorded; current public availability unverified	External access not attempted; not acquired	Not read	The official entry point for the retained registration identifier. Actual page existence/content and current access, acquisition and reading were not established; access was not attempted. Historical manuscript descriptions of paper, registry and publisher cross-checking are historical records. They do not establish current actual reading of external bibliography, abstracts, full text or registration. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted.

Report counts versus independent study counts

The link between report S1 and the retained registration is shown. The PMID, DOI and NCT are not counted as separate independent replications. Total unique trial and participant counts and other direct independent replications remain unverified.

Review criteria

Version 1.1 · Criteria record date 2026-10-05. 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 · Which lotus-leaf preparation, population and body-fat comparison are being checked?

Required materials and conditions: Plant part, extraction, beverage, population, whole-body fat percentage, 0 g comparator and time
Conditions for verification: Link the single question of 12-week whole-body fat percentage for the defined test beverage versus a 0 g beverage to the original record.
Requirement and applicability: Required (selected 12-week whole-body fat-percentage comparison)
Application exceptions: Do not split sex- and dose-specific results into 3 independent effects while their contrasts remain unverified.
Why this condition is needed: Needed to avoid combining this question with tea, other plant parts or weight outcomes.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N02 · Are eligibility criteria, post hoc selection and baseline characteristics of the registered and analyzed populations verified?

Required materials and conditions: Age, BMI, diagnosis, inclusion/exclusion, baseline tables and post hoc selection process
Conditions for verification: Check differences between age 40–60, registered BMI23–30 and analyzed BMI24–28, actual eligibility criteria, the timing and reasons for post hoc selection and baseline characteristics by arm.
Requirement and applicability: Required (selected 12-week whole-body fat-percentage comparison)
Application exceptions: Do not generalize to other ages, BMI ranges or disease populations.
Why this condition is needed: Needed to avoid automatically treating the 60 analyzed participants as representative of the 95 randomized participants.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N03 · Are the plant part, extraction, major constituents and batch-specific assays/manufacturing specifications verified?

Required materials and conditions: Plant species, part, drying, extraction, constituents, manufacturing batches and product material
Conditions for verification: Check recorded hot-water extraction of sun-dried Nelumbo nucifera leaves and major constituents against actual manufacturing-batch, assay and product-specification material.
Requirement and applicability: Required (selected 12-week whole-body fat-percentage comparison)
Application exceptions: Lotus rhizome, plumule, seed and combinations are not the trial intervention.
Why this condition is needed: Needed to avoid transferring the result to ordinary lotus-leaf tea, capsules or isolated constituents.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N04 · What are the route, nominal dose and volume of the test beverage?

Required materials and conditions: Oral administration,400 mL, 2 bottles of 200 mL and 0/1/2 g beverage specifications
Conditions for verification: Link oral 400 mL/day and 0/1/2 g specifications to the corresponding result.
Requirement and applicability: Required (selected 12-week whole-body fat-percentage comparison)
Application exceptions: Checking a nominal dose differs from verifying measured adherence or actual exposure.
Why this condition is needed: Needed to avoid turning trial specifications into personal dosing instructions.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N05 · When were treatment and body-fat assessments performed?

Required materials and conditions: 12-week treatment,6/12-week measurements, completion and follow-up schedule
Conditions for verification: Distinguish 12-week treatment and the selected 12-week result, and link the recorded 6-week assessment.
Requirement and applicability: Required (selected 12-week whole-body fat-percentage comparison)
Application exceptions: Do not substitute a 12-week result for persistence after discontinuation.
Why this condition is needed: Needed to avoid combining outcomes measured at different times as the same value.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N06 · How well are the 0 g control beverage and other conditions matched?

Required materials and conditions: 0 g beverage specifications, appearance/taste, common management and differences between arms
Conditions for verification: Compare the same-format 0 g beverage with the verified scope of taste, management and concomitant conditions.
Requirement and applicability: Required (selected 12-week whole-body fat-percentage comparison)
Application exceptions: Do not relabel the 0 g beverage as no treatment.
Why this condition is needed: Needed to avoid assuming that a beverage comparator establishes matching of all concurrent conditions.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N07 · Are actual allocation, concealment and baseline balance verified?

Required materials and conditions: 3-arm allocation methods, sequence generation, allocation concealment and baseline characteristics by arm
Conditions for verification: Compare the recorded 3-arm randomization with actual sequence-generation, concealment and baseline material.
Requirement and applicability: Required (selected 12-week whole-body fat-percentage comparison)
Application exceptions: Registration timing and randomization procedures do not substitute for each other.
Why this condition is needed: Needed to avoid treating the word randomized as resolution of allocation concerns.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N08 · Can randomization, discontinuation, analysis and other exclusions be distinguished?

Required materials and conditions: 95 randomized, participant flow by arm, 22 discontinuations, 60 analyzed and reasons for 13 additional exclusions
Conditions for verification: Compare 95/22/60, discontinuations 7/6/9 and analyzed counts 22/22/16 by arm, and reasons for the additional 13 exclusions.
Requirement and applicability: Required (selected 12-week whole-body fat-percentage comparison)
Application exceptions: Preserve the original counts and uncertainty without calculating new percentages or dropout rates.
Why this condition is needed: Needed to avoid counting all 13 participants with unverified exclusion reasons as discontinuations.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N09 · How does post hoc BMI selection affect the allocation effect and analysis?

Required materials and conditions: Timing of post hoc selection, selection of completers, retention of randomized groups, exclusions and analysis methods
Conditions for verification: Compare the difference between 95 randomized participants and 60 post-selected completers, and how selection was handled.
Requirement and applicability: Required (selected 12-week whole-body fat-percentage comparison)
Application exceptions: Do not delete observed results because of the selection limitation.
Why this condition is needed: Needed to avoid relabeling selected-completer results as the allocation effect in 95 participants.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N10 · Are the effect of interest and handling of missingness/discontinuation verified?

Required materials and conditions: ITT/PP, missingness mechanisms, imputation, measurement losses, sensitivity analyses and effect of interest
Conditions for verification: Link the full allocation effect with the actual completer analysis and check missing-data handling and sensitivity.
Requirement and applicability: Required (selected 12-week whole-body fat-percentage comparison)
Application exceptions: Do not calculate unrecorded imputations, SDs or full-population results.
Why this condition is needed: Needed to avoid arbitrarily labeling completer selection as ITT.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N11 · Are measurement, calibration and assessment procedures for whole-body fat percentage verified?

Required materials and conditions: Instrument/method, calibration, measurement environment, assessors, timing and consistency between arms
Conditions for verification: Link measurement methods, conditions and blinding for whole-body fat percentage to the actual result.
Requirement and applicability: Required (selected 12-week whole-body fat-percentage comparison)
Application exceptions: Do not infer measurement equipment absent from the retained summary.
Why this condition is needed: Needed to avoid automatically interpreting measurement differences as actual fat changes.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N12 · Are participant/care-provider and outcome-assessor/analyst blinding and its maintenance verified?

Required materials and conditions: Who was blinded, formulation matching, maintenance of blinding and outcome-assessment procedures
Conditions for verification: In addition to recorded participant/care-provider blinding, check actual material on outcome-assessor/analyst blinding, maintenance and verification.
Requirement and applicability: Required (selected 12-week whole-body fat-percentage comparison)
Application exceptions: Unverified blinding does not automatically establish a null effect.
Why this condition is needed: Needed to avoid extending participant/care-provider blinding to assessors and analysts.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N13 · How are differences in lifestyle management, concurrent treatment and adherence handled?

Required materials and conditions: Diet/exercise, concomitant medicines, actual exposure, changes by arm and analytical handling
Conditions for verification: Compare lifestyle management, concomitant treatments, deviations and analytical handling of the effect of interest by arm.
Requirement and applicability: Required (selected 12-week whole-body fat-percentage comparison)
Application exceptions: Do not relabel nominal 1/2 g doses as adherence effects.
Why this condition is needed: Needed to avoid attributing lifestyle or treatment differences to the extract.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N14 · To which time, sex, dose and unit do the original results belong?

Required materials and conditions: 12 weeks, whole-body fat percentage, percentage points, sex/dose and final values/changes
Conditions for verification: Attribute the 12-week percentage-point values for men 1 g/women 1 g/women 2 g to their strata and verify the result format.
Requirement and applicability: Required (selected 12-week whole-body fat-percentage comparison)
Application exceptions: Do not calculate a pooled value from the 3 original results.
Why this condition is needed: Needed to avoid relabeling percentage points as relative percentages or body-weight kg.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N15 · Which comparison do the three reported estimates represent?

Required materials and conditions: Between-group/within-group status, comparator, analysis model, adjustment and estimand for each value
Conditions for verification: Link each percentage-point value’s actual contrast, model and effect of interest to the original result tables.
Requirement and applicability: Required (selected 12-week whole-body fat-percentage comparison)
Application exceptions: Do not fill in between-group contrasts, adjustments or unified main effects by inference.
Why this condition is needed: Needed to avoid transferring a result to a control-group effect merely because it has a P value.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N16 · Are intervals available to interpret uncertainty in the selected contrast?

Required materials and conditions: 95% CI, variance, denominators by stratum and model for each contrast
Conditions for verification: Link intervals for the verified contrast to variance and denominators to explain the range of compatible effects.
Requirement and applicability: Required (selected 12-week whole-body fat-percentage comparison)
Application exceptions: Do not back-calculate CIs from P values or pool the 3 results into a new interval.
Why this condition is needed: Needed to avoid judging precision or sufficiency from significance alone.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N17 · Are a justified importance threshold and the actual contrast/interval for body-fat change verified?

Required materials and conditions: Justified important difference in whole-body fat percentage, population-specific interpretation and intervals
Conditions for verification: Check an importance threshold appropriate to the population and endpoint, and actual comparative estimates/intervals, to review their relationship. If unavailable, retain unverified status.
Requirement and applicability: Required (selected 12-week whole-body fat-percentage comparison)
Application exceptions: Do not adopt arbitrary percentage-point thresholds, minimum sample sizes or completion rates.
Why this condition is needed: Needed to avoid automatically turning statistical significance into clinical importance.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N18 · Do registration timing and original endpoints/analysis plans match the report?

Required materials and conditions: NCT04651023, initial/amended registrations, protocol, SAP and endpoints/times
Conditions for verification: Compare registration 11 years after completion, multiple primary outcomes, actual reporting/selection and reasons for changes with the original plan.
Requirement and applicability: Required (selected 12-week whole-body fat-percentage comparison)
Application exceptions: Do not upgrade historical checking described in a summary to reading the full registration in this work.
Why this condition is needed: Needed to avoid retroactively treating retrospective registration as a prespecified plan.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N19 · How are sex/dose selection and multiple endpoints handled?

Required materials and conditions: Prespecified subgroups, n by stratum, interactions, multiple comparisons and complete-arm results
Conditions for verification: Compare planning of sex/dose selection, complete results, interactions and handling of multiplicity.
Requirement and applicability: Required (selected 12-week whole-body fat-percentage comparison)
Application exceptions: Do not interpret differences between stratum-specific P values as interactions.
Why this condition is needed: Needed to avoid establishing sex or dose differences from positive strata alone.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N20 · Are the family relationship of the Ye report/NCT04651023 and other direct independent replications verified?

Required materials and conditions: PMID/DOI/NCT, study families, independent material and complete results
Conditions for verification: Check the retained PMID/DOI/NCT links, whether recruitment cohorts/results belong to the same family, and identities/independence of other direct replications. Do not establish a replication count without new searching.
Requirement and applicability: Required (selected 12-week whole-body fat-percentage comparison)
Application exceptions: Do not turn no searching in this work into 0 independent trials worldwide.
Why this condition is needed: Needed to avoid counting a report, registration and bibliography as multiple independent trials.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N21 · Are sponsorship, beverage supply, author employment, sponsor design/analysis roles and full COI declarations verified?

Required materials and conditions: Funding, product supply, author employment, declared interests and independent design/analysis
Conditions for verification: In addition to recorded Shanghai Meiji sponsorship, beverage supply and Meiji author employment, check actual material on sponsor control of design/analysis and author-specific COI declarations.
Requirement and applicability: Required (selected 12-week whole-body fat-percentage comparison)
Application exceptions: Do not invent a definite magnitude of bias merely because funding is shared.
Why this condition is needed: Needed to avoid labeling industry involvement as independent research or automatically invalidating it.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N22 · Does this question require an optimal dose or persistence after discontinuation?

Required materials and conditions: Direct dose comparisons, long-term/post-discontinuation follow-up and separate estimates
Conditions for verification: Distinguish the 12-week body-fat-percentage question from separate optimal-dose or persistence questions.
Requirement and applicability: Supplementary; required for optimal-dose or persistence extensions
Application exceptions: Do not automatically use 1/2 g strata as evidence of an optimal dose.
Why this condition is needed: Needed to avoid extending a narrow 12-week effect to every additional question.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N23 · Are body-fat-percentage results being transferred to weight, visceral fat or clinical events?

Required materials and conditions: Separate evidence for selected body-fat percentage versus weight/visceral fat and disease events
Conditions for verification: Distinguish whole-body fat percentage from other endpoints and clinical events.
Requirement and applicability: Supplementary; required for extensions to other endpoints or events
Application exceptions: A registry list of multiple primary outcomes is not the result for each outcome.
Why this condition is needed: Needed to avoid extending a numerical outcome to other endpoints/disease prevention.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N24 · Are the 60-person/12-week report and event definitions, collection and discontinuation reasons for all exposed participants verified?

Required materials and conditions: 60 analyzed, 12 weeks, all exposed participants, event definitions/collection and discontinuation reasons
Conditions for verification: Check the reported 60-person/12-week scope against actual material on all exposed denominators, event definitions, systematic collection and reasons for discontinuation/exclusion.
Requirement and applicability: Supplementary; required for safety claims
Application exceptions: Do not merge efficacy and harm states or calculate new incidence rates.
Why this condition is needed: Needed to avoid turning unreported adverse reactions into safety or 0 events in all 95 participants.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N25 · Are direct data available for vulnerable populations, concomitant medicines and long-term or rare harms?

Required materials and conditions: Pregnancy/lactation, allergy, liver/kidney conditions, blood-pressure/glucose medicines and long-term/rare harms
Conditions for verification: Check actual exposure, event and comparative material for the relevant vulnerable populations, concomitant medicines and long-term/rare harms. Do not convert uncertainty into definite harm or safety.
Requirement and applicability: Supplementary; required for the corresponding safety extension
Application exceptions: Do not convert unverified status into a definite interaction or a personal prohibition on use.
Why this condition is needed: Needed to avoid extending a narrow short-term record to overall safety.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N26 · Are material actually read and historical verification narratives distinguished?

Required materials and conditions: Retained JSON, original review date, bibliography/access, current date and original locations/SHA
Conditions for verification: Separately show the JSON read in this work, unread external material and historical review dates/narratives.
Requirement and applicability: Required (selected 12-week whole-body fat-percentage comparison)
Application exceptions: Do not generate missing typed access dates, locations or levels from historical prose.
Why this condition is needed: Needed to avoid upgrading a historical full-text cross-checking narrative to full-text reading in this work.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N27 · Are the legacy grade, axes, corrections and under-review status preserved?

Required materials and conditions: C 46, EX/CX, original/previous axes, corrections and grade-revalidation flag false
Conditions for verification: Link the original C 46, axes, 2026-09-14 correction and legacy-grade-under-review status to the original text.
Requirement and applicability: Required (selected 12-week whole-body fat-percentage comparison)
Application exceptions: Do not calculate a new grade/score from this checklist’s condition states.
Why this condition is needed: Needed to avoid automatically inheriting a retained grade as the new checklist’s final efficacy assessment.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N28 · Are subsequent evidence, condition changes and verdict changes linked as separate events?

Required materials and conditions: Original results, denominators/contrasts/CIs, registration/SAP, measurement/harms, condition versions and previous values
Conditions for verification: Distinguish the current material scope, affected rows for subsequent material, condition revisions and verdict changes.
Requirement and applicability: Required (selected 12-week whole-body fat-percentage comparison)
Application exceptions: Do not delete unfavorable observations, uncertainty or the original text.
Why this condition is needed: Needed to avoid making new material acquisition automatically change conditions or a verdict.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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; distinguish intervention variants.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

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: Link studies and reports separately; do not omit studies solely because results are unreported.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

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

Referenced principle: Fix the result and effect of interest when examining randomization, deviations, missingness, measurement and selective reporting.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

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: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

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.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

What the statuses mean

Met: The row’s narrow record, attribution, boundary or actual fact was checked. This does not certify efficacy, precision or safety.
Partly verified: Some required information is available, but actual exposure, definitions, denominators or other necessary material remain missing.
Unverified: The criterion cannot be established within the retained scope. This does not mean 0 effect, 0 studies or failed access.
Not applicable: Used only with a reason that an item is outside the actual scope of the selected question. It does not replace unverified or unread status.
Not reported: Nonreporting is limited to a specific material or section actually read. This work did not assign a reporting status to the entire full paper.
Inaccessible: Used only for an actual access failure. Distinguish it from external access not attempted in this work.
Review incomplete: Original-material comparison or searching was not performed within the allowed scope.
Insufficient evidence matching the conditions: Used only after reviewing relevant studies within a defined scope and finding insufficient evidence to answer the condition. It was not applied wholesale to all items in this work.
Conflicting data: Materials that are difficult to reconcile were compared for the same question, time and analysis. Different review figures alone do not establish this status.

Change history

2026-10-28 · Public page/material version 1.0

The public view and materials were prepared from the existing 28 items. No new clinical search, verification-state change or scoring was performed.

The stored-material review date (2026-10-05) and original evidence review date (2026-09-08) were retained unchanged.

Researcher downloads

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

View all item details

N01 · Which lotus-leaf preparation, population and body-fat comparison are being checked?

Current findings: The question concerns whole-body fat percentage at 12 weeks in adults with overweight given a 400 mL beverage containing 1 or 2 g/day hot-water extract of sun-dried lotus leaves. The original subclaim list is empty.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Checking this boundary does not confirm efficacy or revalidate the legacy grade.
Reason for missing information: Checking this boundary does not confirm efficacy or revalidate the legacy grade.
Required materials and conditions: Plant part, extraction, beverage, population, whole-body fat percentage, 0 g comparator and time
Materials to obtain first: Plant part, extraction, beverage, population, whole-body fat percentage, 0 g comparator and time
Further research: Compare subsequent material with the formulation, population, comparator, outcome and time.
Remaining uncertainty: Checking this boundary does not confirm efficacy or revalidate the legacy grade.
Conditions for verification: Link the single question of 12-week whole-body fat percentage for the defined test beverage versus a 0 g beverage to the original record.
Why this condition is needed: Needed to avoid combining this question with tea, other plant parts or weight outcomes.
Application exceptions: Do not split sex- and dose-specific results into 3 independent effects while their contrasts remain unverified.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Related sources S1

N02 · Are eligibility criteria, post hoc selection and baseline characteristics of the registered and analyzed populations verified?

Current findings: The retained record describes 95 registered Chinese adults aged 40–60 with overweight and analysis of 60 completers with BMI24–28.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Baseline balance, complete eligibility criteria, the basis for post hoc criteria and representativeness cannot be established from this record alone.
Reason for missing information: Baseline balance, complete eligibility criteria, the basis for post hoc criteria and representativeness cannot be established from this record alone.
Required materials and conditions: Age, BMI, diagnosis, inclusion/exclusion, baseline tables and post hoc selection process
Materials to obtain first: Age, BMI, diagnosis, inclusion/exclusion, baseline tables and post hoc selection process
Further research: Obtain baseline tables by arm, selection rules, timing of application and reasons for exclusion.
Remaining uncertainty: Baseline balance, complete eligibility criteria, the basis for post hoc criteria and representativeness cannot be established from this record alone.
Conditions for verification: Check differences between age 40–60, registered BMI23–30 and analyzed BMI24–28, actual eligibility criteria, the timing and reasons for post hoc selection and baseline characteristics by arm.
Why this condition is needed: Needed to avoid automatically treating the 60 analyzed participants as representative of the 95 randomized participants.
Application exceptions: Do not generalize to other ages, BMI ranges or disease populations.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Related sources S1

N03 · Are the plant part, extraction, major constituents and batch-specific assays/manufacturing specifications verified?

Current findings: Hot-water extract of sun-dried leaves is recorded, with quercetin-3-O-glucuronide and quercetin as major constituents.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Original material for actual batches, complete constituent assays and manufacturing quality has not been read in this work.
Reason for missing information: Original material for actual batches, complete constituent assays and manufacturing quality has not been read in this work.
Required materials and conditions: Plant species, part, drying, extraction, constituents, manufacturing batches and product material
Materials to obtain first: Plant species, part, drying, extraction, constituents, manufacturing batches and product material
Further research: When product specifications, batch and constituent-assay material become available, compare the plant part, processing and formulation with the actual trial intervention.
Remaining uncertainty: Original material for actual batches, complete constituent assays and manufacturing quality has not been read in this work.
Conditions for verification: Check recorded hot-water extraction of sun-dried Nelumbo nucifera leaves and major constituents against actual manufacturing-batch, assay and product-specification material.
Why this condition is needed: Needed to avoid transferring the result to ordinary lotus-leaf tea, capsules or isolated constituents.
Application exceptions: Lotus rhizome, plumule, seed and combinations are not the trial intervention.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Related sources S1

N04 · What are the route, nominal dose and volume of the test beverage?

Current findings: The record describes oral test beverages of 400 mL/day (2 bottles of 200 mL) containing 0, 1 or 2 g; the intervention doses are 1 or 2 g/day.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Individual actual consumption and adherence are not inferred from these nominal specifications.
Reason for missing information: Individual actual consumption and adherence are not inferred from these nominal specifications.
Required materials and conditions: Oral administration,400 mL, 2 bottles of 200 mL and 0/1/2 g beverage specifications
Materials to obtain first: Oral administration,400 mL, 2 bottles of 200 mL and 0/1/2 g beverage specifications
Further research: Separately compare actual consumption, adherence, batches and exposure by arm.
Remaining uncertainty: Individual actual consumption and adherence are not inferred from these nominal specifications.
Conditions for verification: Link oral 400 mL/day and 0/1/2 g specifications to the corresponding result.
Why this condition is needed: Needed to avoid turning trial specifications into personal dosing instructions.
Application exceptions: Checking a nominal dose differs from verifying measured adherence or actual exposure.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Related sources S1

N05 · When were treatment and body-fat assessments performed?

Current findings: Treatment lasted 12 weeks and the original primary endpoint specifies changes in whole-body fat percentage at 6 and 12 weeks. The retained numerical results are at 12 weeks.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Detailed 6-week results and persistence beyond 12 weeks are not available in this record.
Reason for missing information: Detailed 6-week results and persistence beyond 12 weeks are not available in this record.
Required materials and conditions: 12-week treatment,6/12-week measurements, completion and follow-up schedule
Materials to obtain first: 12-week treatment,6/12-week measurements, completion and follow-up schedule
Further research: Obtain time-specific result tables and follow-up after treatment stops.
Remaining uncertainty: Detailed 6-week results and persistence beyond 12 weeks are not available in this record.
Conditions for verification: Distinguish 12-week treatment and the selected 12-week result, and link the recorded 6-week assessment.
Why this condition is needed: Needed to avoid combining outcomes measured at different times as the same value.
Application exceptions: Do not substitute a 12-week result for persistence after discontinuation.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Related sources S1

N06 · How well are the 0 g control beverage and other conditions matched?

Current findings: The comparator is recorded as the same-format test beverage containing 0 g extract.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Detailed taste/appearance matching, shared lifestyle management, concomitant conditions and changes remain unverified.
Reason for missing information: Detailed taste/appearance matching, shared lifestyle management, concomitant conditions and changes remain unverified.
Required materials and conditions: 0 g beverage specifications, appearance/taste, common management and differences between arms
Materials to obtain first: 0 g beverage specifications, appearance/taste, common management and differences between arms
Further research: Obtain control ingredients, blinding, common management and treatment changes by arm.
Remaining uncertainty: Detailed taste/appearance matching, shared lifestyle management, concomitant conditions and changes remain unverified.
Conditions for verification: Compare the same-format 0 g beverage with the verified scope of taste, management and concomitant conditions.
Why this condition is needed: Needed to avoid assuming that a beverage comparator establishes matching of all concurrent conditions.
Application exceptions: Do not relabel the 0 g beverage as no treatment.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Related sources S1

N07 · Are actual allocation, concealment and baseline balance verified?

Current findings: The record describes a randomized 3-arm trial with participant/care-provider blinding and a 0 g beverage comparator.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Detailed original material on sequence generation, concealment and baseline balance cannot be checked from the retained summary alone.
Reason for missing information: Detailed original material on sequence generation, concealment and baseline balance cannot be checked from the retained summary alone.
Required materials and conditions: 3-arm allocation methods, sequence generation, allocation concealment and baseline characteristics by arm
Materials to obtain first: 3-arm allocation methods, sequence generation, allocation concealment and baseline characteristics by arm
Further research: Link methods/allocation material and baseline tables by arm to review the verified scope of sequence generation, concealment and baseline balance.
Remaining uncertainty: Detailed original material on sequence generation, concealment and baseline balance cannot be checked from the retained summary alone.
Conditions for verification: Compare the recorded 3-arm randomization with actual sequence-generation, concealment and baseline material.
Why this condition is needed: Needed to avoid treating the word randomized as resolution of allocation concerns.
Application exceptions: Registration timing and randomization procedures do not substitute for each other.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Related sources S1

N08 · Can randomization, discontinuation, analysis and other exclusions be distinguished?

Current findings: The original record distinguishes 95 randomized participants, 22 discontinuations and 60 overweight completers analyzed. Discontinuations by arm were 7/6/9 and analyzed counts 22/22/16; reasons for excluding the other 13 remain unverified.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Complete allocation/measurement denominators by arm and reasons for excluding 13 participants cannot currently be verified. Do not count all 13 as discontinuations.
Reason for missing information: Complete allocation/measurement denominators by arm and reasons for excluding 13 participants cannot currently be verified. Do not count all 13 as discontinuations.
Required materials and conditions: 95 randomized, participant flow by arm, 22 discontinuations, 60 analyzed and reasons for 13 additional exclusions
Materials to obtain first: 95 randomized, participant flow by arm, 22 discontinuations, 60 analyzed and reasons for 13 additional exclusions
Further research: Obtain complete CONSORT flow, randomized/measured/analyzed counts by arm, reasons for exclusion and timing.
Remaining uncertainty: Complete allocation/measurement denominators by arm and reasons for excluding 13 participants cannot currently be verified. Do not count all 13 as discontinuations.
Conditions for verification: Compare 95/22/60, discontinuations 7/6/9 and analyzed counts 22/22/16 by arm, and reasons for the additional 13 exclusions.
Why this condition is needed: Needed to avoid counting all 13 participants with unverified exclusion reasons as discontinuations.
Application exceptions: Preserve the original counts and uncertainty without calculating new percentages or dropout rates.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Related sources S1

N09 · How does post hoc BMI selection affect the allocation effect and analysis?

Current findings: The record says PubMed’s n=60 is the number of completers meeting post hoc overweight criteria, rather than the randomized denominator.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Analytical handling of selection and the allocation effect in all 95 participants remain unverified within this retained scope.
Reason for missing information: Analytical handling of selection and the allocation effect in all 95 participants remain unverified within this retained scope.
Required materials and conditions: Timing of post hoc selection, selection of completers, retention of randomized groups, exclusions and analysis methods
Materials to obtain first: Timing of post hoc selection, selection of completers, retention of randomized groups, exclusions and analysis methods
Further research: Obtain prespecified plans, full-arm analyses, exclusion reasons and sensitivity analyses for selection.
Remaining uncertainty: Analytical handling of selection and the allocation effect in all 95 participants remain unverified within this retained scope.
Conditions for verification: Compare the difference between 95 randomized participants and 60 post-selected completers, and how selection was handled.
Why this condition is needed: Needed to avoid relabeling selected-completer results as the allocation effect in 95 participants.
Application exceptions: Do not delete observed results because of the selection limitation.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N10 · Are the effect of interest and handling of missingness/discontinuation verified?

Current findings: The original summary distinguishes a post hoc analysis of 60 completers from 95 randomized participants.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Missing-data handling, the effect of interest, full-randomized-analysis results and sensitivity cannot be established at the locations read in this work.
Reason for missing information: Missing-data handling, the effect of interest, full-randomized-analysis results and sensitivity cannot be established at the locations read in this work.
Required materials and conditions: ITT/PP, missingness mechanisms, imputation, measurement losses, sensitivity analyses and effect of interest
Materials to obtain first: ITT/PP, missingness mechanisms, imputation, measurement losses, sensitivity analyses and effect of interest
Further research: Obtain the analysis plan, missingness by arm, full-randomized analyses and sensitivity analyses.
Remaining uncertainty: Missing-data handling, the effect of interest, full-randomized-analysis results and sensitivity cannot be established at the locations read in this work.
Conditions for verification: Link the full allocation effect with the actual completer analysis and check missing-data handling and sensitivity.
Why this condition is needed: Needed to avoid arbitrarily labeling completer selection as ITT.
Application exceptions: Do not calculate unrecorded imputations, SDs or full-population results.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N11 · Are measurement, calibration and assessment procedures for whole-body fat percentage verified?

Current findings: The selected outcome is whole-body fat percentage at 12 weeks; the claim conditions specify changes at 6/12 weeks.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Measurement equipment, calibration, environment and assessor procedures cannot be verified in the retained record.
Reason for missing information: Measurement equipment, calibration, environment and assessor procedures cannot be verified in the retained record.
Required materials and conditions: Instrument/method, calibration, measurement environment, assessors, timing and consistency between arms
Materials to obtain first: Instrument/method, calibration, measurement environment, assessors, timing and consistency between arms
Further research: Obtain original methods, instrument/calibration information, measurement environment and assessment procedures.
Remaining uncertainty: Measurement equipment, calibration, environment and assessor procedures cannot be verified in the retained record.
Conditions for verification: Link measurement methods, conditions and blinding for whole-body fat percentage to the actual result.
Why this condition is needed: Needed to avoid automatically interpreting measurement differences as actual fat changes.
Application exceptions: Do not infer measurement equipment absent from the retained summary.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N12 · Are participant/care-provider and outcome-assessor/analyst blinding and its maintenance verified?

Current findings: The original design field records participant/care-provider blinding.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Outcome-assessor/analyst blinding and checks that blinding was maintained cannot be verified from the retained material alone.
Reason for missing information: Outcome-assessor/analyst blinding and checks that blinding was maintained cannot be verified from the retained material alone.
Required materials and conditions: Who was blinded, formulation matching, maintenance of blinding and outcome-assessment procedures
Materials to obtain first: Who was blinded, formulation matching, maintenance of blinding and outcome-assessment procedures
Further research: Obtain methods, formulation matching, maintenance of blinding and assessment/analysis procedures.
Remaining uncertainty: Outcome-assessor/analyst blinding and checks that blinding was maintained cannot be verified from the retained material alone.
Conditions for verification: In addition to recorded participant/care-provider blinding, check actual material on outcome-assessor/analyst blinding, maintenance and verification.
Why this condition is needed: Needed to avoid extending participant/care-provider blinding to assessors and analysts.
Application exceptions: Unverified blinding does not automatically establish a null effect.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N13 · How are differences in lifestyle management, concurrent treatment and adherence handled?

Current findings: The original claim conditions retain beverage volume, nominal extract doses and duration.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Diet/exercise, concomitant medicines, consumption adherence, rescue treatment and their handling by arm remain unverified.
Reason for missing information: Diet/exercise, concomitant medicines, consumption adherence, rescue treatment and their handling by arm remain unverified.
Required materials and conditions: Diet/exercise, concomitant medicines, actual exposure, changes by arm and analytical handling
Materials to obtain first: Diet/exercise, concomitant medicines, actual exposure, changes by arm and analytical handling
Further research: Obtain common-management arrangements, medication/lifestyle changes, adherence and handling by arm.
Remaining uncertainty: Diet/exercise, concomitant medicines, consumption adherence, rescue treatment and their handling by arm remain unverified.
Conditions for verification: Compare lifestyle management, concomitant treatments, deviations and analytical handling of the effect of interest by arm.
Why this condition is needed: Needed to avoid attributing lifestyle or treatment differences to the extract.
Application exceptions: Do not relabel nominal 1/2 g doses as adherence effects.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N14 · To which time, sex, dose and unit do the original results belong?

Current findings: Retained 12-week results are men 1 g/day,-2.6 percentage points (P=.019); women 1 g/day,-3.7 percentage points (P=.009); and women 2 g/day,-2.9 percentage points (P=.027).
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Stratum-specific n, calculation definitions, baseline/final values and whether contrasts are between-group or within-group remain unverified.
Reason for missing information: Stratum-specific n, calculation definitions, baseline/final values and whether contrasts are between-group or within-group remain unverified.
Required materials and conditions: 12 weeks, whole-body fat percentage, percentage points, sex/dose and final values/changes
Materials to obtain first: 12 weeks, whole-body fat percentage, percentage points, sex/dose and final values/changes
Further research: Obtain original result tables, time-specific baseline/final values, change definitions and denominators by stratum.
Remaining uncertainty: Stratum-specific n, calculation definitions, baseline/final values and whether contrasts are between-group or within-group remain unverified.
Conditions for verification: Attribute the 12-week percentage-point values for men 1 g/women 1 g/women 2 g to their strata and verify the result format.
Why this condition is needed: Needed to avoid relabeling percentage points as relative percentages or body-weight kg.
Application exceptions: Do not calculate a pooled value from the 3 original results.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N15 · Which comparison do the three reported estimates represent?

Current findings: The original Korean/English record explicitly says whether the three values are between-group differences or within-group changes remains unverified.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Without verified actual contrasts and analysis models, the three values do not establish between-group effects or a unified main effect.
Reason for missing information: Without verified actual contrasts and analysis models, the three values do not establish between-group effects or a unified main effect.
Required materials and conditions: Between-group/within-group status, comparator, analysis model, adjustment and estimand for each value
Materials to obtain first: Between-group/within-group status, comparator, analysis model, adjustment and estimand for each value
Further research: Link arm order, contrast, model and stratum-specific denominators in each result table to distinguish between-group estimates from within-group changes.
Remaining uncertainty: Without verified actual contrasts and analysis models, the three values do not establish between-group effects or a unified main effect.
Conditions for verification: Link each percentage-point value’s actual contrast, model and effect of interest to the original result tables.
Why this condition is needed: Needed to avoid transferring a result to a control-group effect merely because it has a P value.
Application exceptions: Do not fill in between-group contrasts, adjustments or unified main effects by inference.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N16 · Are intervals available to interpret uncertainty in the selected contrast?

Current findings: The retained results include P=.019/.009/.027 and a statement that 95% CIs were not reported.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Actual CIs, variance, n and contrasts for each stratum were not verified within the material read. Do not extend this to nonreporting throughout the entire paper.
Reason for missing information: Actual CIs, variance, n and contrasts for each stratum were not verified within the material read. Do not extend this to nonreporting throughout the entire paper.
Required materials and conditions: 95% CI, variance, denominators by stratum and model for each contrast
Materials to obtain first: 95% CI, variance, denominators by stratum and model for each contrast
Further research: Link original result-table contrasts, variance, stratum-specific denominators and reported CIs to assess whether intervals are interpretable. Do not perform new back-calculations.
Remaining uncertainty: Actual CIs, variance, n and contrasts for each stratum were not verified within the material read. Do not extend this to nonreporting throughout the entire paper.
Conditions for verification: Link intervals for the verified contrast to variance and denominators to explain the range of compatible effects.
Why this condition is needed: Needed to avoid judging precision or sufficiency from significance alone.
Application exceptions: Do not back-calculate CIs from P values or pool the 3 results into a new interval.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N17 · Are a justified importance threshold and the actual contrast/interval for body-fat change verified?

Current findings: The retained record provides sex- and dose-specific body-fat percentages and P values, while a unified main effect/CIs remain unverified.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: An importance threshold and estimate intervals for comparison have not been verified in this work.
Reason for missing information: An importance threshold and estimate intervals for comparison have not been verified in this work.
Required materials and conditions: Justified important difference in whole-body fat percentage, population-specific interpretation and intervals
Materials to obtain first: Justified important difference in whole-body fat percentage, population-specific interpretation and intervals
Further research: Obtain the basis for importance, patient-relevant outcomes and contrast-specific intervals.
Remaining uncertainty: An importance threshold and estimate intervals for comparison have not been verified in this work.
Conditions for verification: Check an importance threshold appropriate to the population and endpoint, and actual comparative estimates/intervals, to review their relationship. If unavailable, retain unverified status.
Why this condition is needed: Needed to avoid automatically turning statistical significance into clinical importance.
Application exceptions: Do not adopt arbitrary percentage-point thresholds, minimum sample sizes or completion rates.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N18 · Do registration timing and original endpoints/analysis plans match the report?

Current findings: NCT04651023 is recorded as posted 11 years after study completion. Weight, body fat, visceral fat, waist and hip were listed as multiple primary outcomes.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Registration, protocol and SAP bytes remain unread in this work; complete comparison of prespecified analyses/endpoints and changes remains pending.
Reason for missing information: Registration, protocol and SAP bytes remain unread in this work; complete comparison of prespecified analyses/endpoints and changes remains pending.
Required materials and conditions: NCT04651023, initial/amended registrations, protocol, SAP and endpoints/times
Materials to obtain first: NCT04651023, initial/amended registrations, protocol, SAP and endpoints/times
Further research: Obtain registration history, prospective protocol/SAP, complete results and reasons for changes.
Remaining uncertainty: Registration, protocol and SAP bytes remain unread in this work; complete comparison of prespecified analyses/endpoints and changes remains pending.
Conditions for verification: Compare registration 11 years after completion, multiple primary outcomes, actual reporting/selection and reasons for changes with the original plan.
Why this condition is needed: Needed to avoid retroactively treating retrospective registration as a prespecified plan.
Application exceptions: Do not upgrade historical checking described in a summary to reading the full registration in this work.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N19 · How are sex/dose selection and multiple endpoints handled?

Current findings: The paper selected sex- and dose-specific completer results; retained positive strata are men 1 g, women 1 g and women 2 g.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Prespecification, interactions, multiplicity handling and complete results including men 2 g remain unverified.
Reason for missing information: Prespecification, interactions, multiplicity handling and complete results including men 2 g remain unverified.
Required materials and conditions: Prespecified subgroups, n by stratum, interactions, multiple comparisons and complete-arm results
Materials to obtain first: Prespecified subgroups, n by stratum, interactions, multiple comparisons and complete-arm results
Further research: Obtain prespecified analysis plans, all stratum results, interaction estimates and multiplicity handling.
Remaining uncertainty: Prespecification, interactions, multiplicity handling and complete results including men 2 g remain unverified.
Conditions for verification: Compare planning of sex/dose selection, complete results, interactions and handling of multiplicity.
Why this condition is needed: Needed to avoid establishing sex or dose differences from positive strata alone.
Application exceptions: Do not interpret differences between stratum-specific P values as interactions.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N20 · Are the family relationship of the Ye report/NCT04651023 and other direct independent replications verified?

Current findings: One evidence/citation record retains PMID34852695, DOI10.1080/14786419.2021.2010196 and NCT04651023. The manuscript says independent replication was not verified.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: No current certification of unique families/participant independence or new literature search was performed. Do not establish 0 independent replications.
Reason for missing information: No current certification of unique families/participant independence or new literature search was performed. Do not establish 0 independent replications.
Required materials and conditions: PMID/DOI/NCT, study families, independent material and complete results
Materials to obtain first: PMID/DOI/NCT, study families, independent material and complete results
Further research: Obtain study-family tables, registry/report links and independent material addressing the same question.
Remaining uncertainty: No current certification of unique families/participant independence or new literature search was performed. Do not establish 0 independent replications.
Conditions for verification: Check the retained PMID/DOI/NCT links, whether recruitment cohorts/results belong to the same family, and identities/independence of other direct replications. Do not establish a replication count without new searching.
Why this condition is needed: Needed to avoid counting a report, registration and bibliography as multiple independent trials.
Application exceptions: Do not turn no searching in this work into 0 independent trials worldwide.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N21 · Are sponsorship, beverage supply, author employment, sponsor design/analysis roles and full COI declarations verified?

Current findings: The record describes sponsorship by Shanghai Meiji Health Science and Technology, provision of test beverages and several authors employed in Meiji R&D.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Sponsor control of design/analysis and complete author-specific COI details remain unverified.
Reason for missing information: Sponsor control of design/analysis and complete author-specific COI details remain unverified.
Required materials and conditions: Funding, product supply, author employment, declared interests and independent design/analysis
Materials to obtain first: Funding, product supply, author employment, declared interests and independent design/analysis
Further research: Obtain original funding/COI declarations, roles, analytical control and author-specific disclosures.
Remaining uncertainty: Sponsor control of design/analysis and complete author-specific COI details remain unverified.
Conditions for verification: In addition to recorded Shanghai Meiji sponsorship, beverage supply and Meiji author employment, check actual material on sponsor control of design/analysis and author-specific COI declarations.
Why this condition is needed: Needed to avoid labeling industry involvement as independent research or automatically invalidating it.
Application exceptions: Do not invent a definite magnitude of bias merely because funding is shared.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N22 · Does this question require an optimal dose or persistence after discontinuation?

Current findings: This checklist concerns 12-week body-fat percentage and does not adopt optimal-dose or maintenance claims. Sex/dose observations are retained in separate rows.
Verification status: Not applicable
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Extension effects themselves remain unverified. Do not require every dose/long-term trial as essential to the current narrow question.
Reason for missing information: Extension effects themselves remain unverified. Do not require every dose/long-term trial as essential to the current narrow question.
Required materials and conditions: Direct dose comparisons, long-term/post-discontinuation follow-up and separate estimates
Materials to obtain first: Direct dose comparisons, long-term/post-discontinuation follow-up and separate estimates
Further research: If an extension is requested, separately design dose-versus-dose comparisons and long-term/post-discontinuation follow-up.
Remaining uncertainty: Extension effects themselves remain unverified. Do not require every dose/long-term trial as essential to the current narrow question.
Conditions for verification: Distinguish the 12-week body-fat-percentage question from separate optimal-dose or persistence questions.
Why this condition is needed: Needed to avoid extending a narrow 12-week effect to every additional question.
Application exceptions: Do not automatically use 1/2 g strata as evidence of an optimal dose.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N23 · Are body-fat-percentage results being transferred to weight, visceral fat or clinical events?

Current findings: The manuscript explicitly says the result cannot be extended to reduced weight/visceral fat or efficacy of ordinary lotus-leaf tea.
Verification status: Not applicable
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Confirmation of other endpoints/events is not added as essential to the current body-fat-percentage question. This checklist does not certify those effects.
Reason for missing information: Confirmation of other endpoints/events is not added as essential to the current body-fat-percentage question. This checklist does not certify those effects.
Required materials and conditions: Separate evidence for selected body-fat percentage versus weight/visceral fat and disease events
Materials to obtain first: Separate evidence for selected body-fat percentage versus weight/visceral fat and disease events
Further research: If an extension is requested, separately review actual endpoint-specific results and disease events for the same preparation.
Remaining uncertainty: Confirmation of other endpoints/events is not added as essential to the current body-fat-percentage question. This checklist does not certify those effects.
Conditions for verification: Distinguish whole-body fat percentage from other endpoints and clinical events.
Why this condition is needed: Needed to avoid extending a numerical outcome to other endpoints/disease prevention.
Application exceptions: A registry list of multiple primary outcomes is not the result for each outcome.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N24 · Are the 60-person/12-week report and event definitions, collection and discontinuation reasons for all exposed participants verified?

Current findings: The original safety description records no reported test-beverage adverse reactions among the 60 analyzed participants.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: This does not establish 0 events among all 95 participants, systematic collection or reasons for discontinuation/exclusion. Limitations of a short-term selected sample remain.
Reason for missing information: This does not establish 0 events among all 95 participants, systematic collection or reasons for discontinuation/exclusion. Limitations of a short-term selected sample remain.
Required materials and conditions: 60 analyzed, 12 weeks, all exposed participants, event definitions/collection and discontinuation reasons
Materials to obtain first: 60 analyzed, 12 weeks, all exposed participants, event definitions/collection and discontinuation reasons
Further research: Obtain all exposed participants by arm, event counts, collection methods and discontinuation reasons.
Remaining uncertainty: This does not establish 0 events among all 95 participants, systematic collection or reasons for discontinuation/exclusion. Limitations of a short-term selected sample remain.
Conditions for verification: Check the reported 60-person/12-week scope against actual material on all exposed denominators, event definitions, systematic collection and reasons for discontinuation/exclusion.
Why this condition is needed: Needed to avoid turning unreported adverse reactions into safety or 0 events in all 95 participants.
Application exceptions: Do not merge efficacy and harm states or calculate new incidence rates.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N25 · Are direct data available for vulnerable populations, concomitant medicines and long-term or rare harms?

Current findings: The original safety record leaves pregnancy, lactation, allergy, liver/kidney disease and interactions with blood-pressure/glucose medicines unverified.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Direct comparisons for these populations/medicines and long-term/rare-harm material have not been verified in this work.
Reason for missing information: Direct comparisons for these populations/medicines and long-term/rare-harm material have not been verified in this work.
Required materials and conditions: Pregnancy/lactation, allergy, liver/kidney conditions, blood-pressure/glucose medicines and long-term/rare harms
Materials to obtain first: Pregnancy/lactation, allergy, liver/kidney conditions, blood-pressure/glucose medicines and long-term/rare harms
Further research: Obtain comparative exposure/event material for those populations and concomitant medicines, and long-term follow-up.
Remaining uncertainty: Direct comparisons for these populations/medicines and long-term/rare-harm material have not been verified in this work.
Conditions for verification: Check actual exposure, event and comparative material for the relevant vulnerable populations, concomitant medicines and long-term/rare harms. Do not convert uncertainty into definite harm or safety.
Why this condition is needed: Needed to avoid extending a narrow short-term record to overall safety.
Application exceptions: Do not convert unverified status into a definite interaction or a personal prohibition on use.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N26 · Are material actually read and historical verification narratives distinguished?

Current findings: The material read in this work is the complete current retained JSON. The original review date 2026-09-08 and historical narrative of PMID/NCT/publisher cross-checking are retained.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: External full text, registration, publisher PDF and SAP remain unread/unacquired in this work. Typed access-level, individual access-date and location fields are absent from the original bibliography.
Reason for missing information: External full text, registration, publisher PDF and SAP remain unread/unacquired in this work. Typed access-level, individual access-date and location fields are absent from the original bibliography.
Required materials and conditions: Retained JSON, original review date, bibliography/access, current date and original locations/SHA
Materials to obtain first: Retained JSON, original review date, bibliography/access, current date and original locations/SHA
Further research: When material is later acquired, record identity, material type, date, access/reading, locations and byte SHA.
Remaining uncertainty: External full text, registration, publisher PDF and SAP remain unread/unacquired in this work. Typed access-level, individual access-date and location fields are absent from the original bibliography.
Conditions for verification: Separately show the JSON read in this work, unread external material and historical review dates/narratives.
Why this condition is needed: Needed to avoid upgrading a historical full-text cross-checking narrative to full-text reading in this work.
Application exceptions: Do not generate missing typed access dates, locations or levels from historical prose.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N27 · Are the legacy grade, axes, corrections and under-review status preserved?

Current findings: The original C 46,S/R1/I0/EX/B2/CX, grade-revalidation flag false, legacy-grade-under-review status and 2026-09-14 correction are retained.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The legacy grade remains under review. This conversion is not a final reassessment or calculation of values/CIs.
Reason for missing information: The legacy grade remains under review. This conversion is not a final reassessment or calculation of values/CIs.
Required materials and conditions: C 46, EX/CX, original/previous axes, corrections and grade-revalidation flag false
Materials to obtain first: C 46, EX/CX, original/previous axes, corrections and grade-revalidation flag false
Further research: If reassessment is later requested, preserve the original, previous values, new evidence and change decision as a separate event.
Remaining uncertainty: The legacy grade remains under review. This conversion is not a final reassessment or calculation of values/CIs.
Conditions for verification: Link the original C 46, axes, 2026-09-14 correction and legacy-grade-under-review status to the original text.
Why this condition is needed: Needed to avoid automatically inheriting a retained grade as the new checklist’s final efficacy assessment.
Application exceptions: Do not calculate a new grade/score from this checklist’s condition states.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N28 · Are subsequent evidence, condition changes and verdict changes linked as separate events?

Current findings: Current limitations in denominator selection, individual contrasts/CIs, retrospective registration, multiple analyses, industry funding and safety, and the original correction, are retained. Subsequent checks are linked to each row.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: New evidence, reassessment and public deployment were not performed in the retained case record.
Reason for missing information: New evidence, reassessment and public deployment were not performed in the retained case record.
Required materials and conditions: Original results, denominators/contrasts/CIs, registration/SAP, measurement/harms, condition versions and previous values
Materials to obtain first: Original results, denominators/contrasts/CIs, registration/SAP, measurement/harms, condition versions and previous values
Further research: Record identity, reading and locations; review affected rows, and freeze a revised condition version before application.
Remaining uncertainty: New evidence, reassessment and public deployment were not performed in the retained case record.
Conditions for verification: Distinguish the current material scope, affected rows for subsequent material, condition revisions and verdict changes.
Why this condition is needed: Needed to avoid making new material acquisition automatically change conditions or a verdict.
Application exceptions: Do not delete unfavorable observations, uncertainty or the original text.
Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Related sources S1