Psyllium × MRI liver fat: an unmeasured outcome and gaps behind surrogate findings

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionWhich MRI claim is selected?Required	The selected claim is reduced MRI-measured liver fat. Its original grade is ? and its note says this was not an outcome measured by the trial. Subclaim score, status and axes are unrecorded and distinguished from the parent ALT/FibroScan verdict C50. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	The existing MRI liver-fat-reduction claim and verdict record	Material needed: Definitions, population, comparator, time points and denominators for direct MRI measurement, and review of the existing claim boundary, are needed. The ? does not mean zero effect, zero points or absence of all human research. This records needed materials; no new research was executed.
2	Unverified	Full text not readStored summary read	N02 · Evidence conditionWas MRI liver fat directly measured?Required	The existing crux, summary note and subclaim note record that the trial did not measure MRI liver fat. MRI values, between-group changes, CIs and measurement denominators are not filled using ALT/FibroScan findings. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Unmeasured MRI and the direct-evidence gap	Material needed: Actual MRI liver-fat methods, quantification, units, baseline and follow-up measurements, comparator, denominators and CIs are needed. An unmeasured outcome is not a test showing no effect. This records needed materials; no new research was executed.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionDoes ALT P=.006 establish an MRI liver-fat effect?Required	Original ALT P=.006 is a covariate-adjusted liver-enzyme result, not MRI fat quantity, change or a CI. It is not converted into an MRI liver-fat-reduction effect or amount of normalization. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Distinguishing liver enzymes from a direct MRI endpoint	Material needed: Original ALT tables and separate direct MRI data, definitions, models, denominators and CIs are needed. Original P values are preserved without new effect or fat-quantity calculations. This records needed materials; no new research was executed.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionIs FibroScan P=.001 the same measurement as MRI?Required	The original wording of FibroScan fibrosis score P=.001 and the existing explanation that it differs from MRI are preserved. Actual measure, units and device algorithm are unverified and are not converted into MRI fat quantity. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Distinguishing the actual FibroScan measure from MRI methods	Material needed: FibroScan definitions and valid measurements, direct MRI quantification methods, and their respective denominators, models and CIs are needed. A device name alone does not establish fat measurement or histologic effects. This records needed materials; no new research was executed.
5	Unverified	Full text not readStored summary read	N05 · Evidence conditionAre MRI, MRS, other imaging and histologic outcomes individually verified?Required	The existing advertising analysis cautions against adding unmeasured MRI or histologic liver-fat findings. Detailed MRS, other imaging and histologic results and values are also not verified as separate direct outcomes in the stored summary. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Actual measurement by each imaging method and histologic indicator	Material needed: Actual performance, purpose, definitions, units, time points, denominators and CIs for each method or histologic measure are needed. Unverified information is not replaced with confirmed performance or a zero result. This records needed materials; no new research was executed.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionDoes the null AST result establish a null MRI fat result?Required	AST P=.98 is the original null liver-enzyme test result. It is not transferred into zero MRI effect or equivalence for an unmeasured outcome, or obscured by favorable ALT findings. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Distinguishing AST P=.98 from other unmeasured tests	Material needed: Test-specific values, denominators, between-group effects, CIs, prespecified hierarchy and separate MRI data are needed. No new conversion between tests is made. This records needed materials; no new research was executed.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionAre clinical liver-disease outcomes and MRI measurements the same endpoint?Required	The Korean text says whether marker changes lead to cirrhosis or hospitalization is unknown; the English text says clinical liver events were not tested. MRI fat quantity is also distinct from clinical-event effects and was not directly measured in this trial. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Clinical outcomes such as cirrhosis or hospitalization and direct MRI evidence	Material needed: Clinical-event definitions, adjudication, long-term follow-up, group-specific time at risk, denominators, effects, CIs and direct MRI data are needed. No conversion into zero events or treatment efficacy is made. This records needed materials; no new research was executed.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionIs the MASLD population the same as the separate NAFLD seed trial?Required	The main trial involved 80 adults with overweight or obesity and MASLD. The 2016 supporting safety citation concerns NAFLD seed intervention and anthropometry. Differences in diagnosis, disease stage, baseline imaging, medication and formulation are not merged into evidence for the same MRI efficacy question. R01 R02	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Distinguishing the overweight/obese MASLD population from another seed trial	Material needed: Report-specific populations, diagnoses, baseline imaging, liver disease, medication, interventions, durations and direct MRI evidence are needed. No generalization to every liver disease or formulation is made. This records needed materials; no new research was executed.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionCan common diet advice and comparator conditions substitute for MRI effects?Required	The 10g/day interventions, ground-wheat comparator, weight-loss diet and physical-activity advice in both groups are original study conditions. Common advice or weight changes are not assumed to establish MRI liver-fat improvement, an isolated effect or a comparison with no treatment. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	The psyllium versus ground-wheat comparison and common lifestyle advice	Material needed: Actual diet, activity, weight, medication, adherence, comparator, exposure and direct MRI measurement data are needed. No new diet, liver-disease-management or intake advice is created. This records needed materials; no new research was executed.
10	Unverified	Full text not readStored summary read	N10 · Evidence conditionAre 80 randomized and 78 completed MRI measurement denominators?Required	80 randomized and 78 completed describe participation in the main trial, not numbers or denominators measured by MRI. Time points, tests and report counts are not added as independent trials or participants. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Distinguishing randomized/completed counts from an unmeasured endpoint denominator	Material needed: Group-specific randomization, valid scans, missingness, analysis flow, effects and CIs from direct MRI research are needed. No new valid MRI denominator, dropout count or dropout rate is calculated. This records needed materials; no new research was executed.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionDoes ten-week study exposure show sustained MRI effects?Required	Ten weeks, psyllium10g/day and ground wheat10g/day identify the original efficacy trial. With MRI unmeasured, no ten-week MRI effect, persistence, subsequent fat quantity or long-term safety is created. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Duration, actual exposure and post-trial follow-up	Material needed: Direct MRI baseline, follow-up and post-trial data, actual exposure, denominators, comparator and duration are needed. No product-intake, maintenance or treatment-replacement instructions are created. This records needed materials; no new research was executed.
12	Unverified	Full text not readStored summary read	N12 · Evidence conditionDid registration or the prespecified endpoint hierarchy include MRI?Required	The original record leaves effect size, prespecified primary-endpoint hierarchy and registration unverified; MRI was not a measured endpoint. Registration identifiers or plans are not invented to verify MRI as a prespecified or later endpoint. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Distinguishing unverified registration/prespecified endpoints from unmeasured MRI	Material needed: Original registration and amendment history, protocols, SAPs, actual endpoints, time points and direct MRI design data are needed. External registration and planning materials remain unread. This records needed materials; no new research was executed.
13	Unverified	Full text not readStored summary read	N13 · Evidence conditionCan P values from other tests fill MRI effects or CIs?Required	MRI values, direct effects and CIs remain a gap because MRI was not measured. Covariate-adjusted ALT/FibroScan P values and the parent verdict's interpretation do not provide quantitative MRI evidence. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Direct estimates, within/between-group comparisons and unmeasured outcomes	Material needed: Direct MRI group values, baseline, changes, adjusted estimates, 95%CIs, units, denominators and clinical importance are needed. No new calculations, hypothetical examples or effect sizes are created. This records needed materials; no new research was executed.
14	Unverified	Full text not readStored summary read	N14 · Evidence conditionWhat direct evidence would address the MRI gap?Required	The current record contains selected ten-week liver-test signals and unmeasured MRI. Other surrogates or the separate seed safety citation do not fill this gap; needed direct MRI materials are identified. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	MRI measurements addressing the same question	Material needed: MRI liver-fat methods, baseline, follow-up, denominators, effects, CIs, actual exposure and harms for the same formulation, common advice, comparator and selected MASLD population are needed. Only research needs are recorded; no new research, calculation or regrading is performed. This records needed materials; no new research was executed.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionAre the same reports, participants or time points counted as independent evidence?Required	Parent2985 and the ALT/FibroScan and MRI sheets share the Akbarzadeh2026 efficacy-trial context and Akbarian2016 supporting safety citation. Tests, conditions and time points from the same participants are not added as new independent trials or people. Unique-trial and total unique-participant counts remain unverified. R01 R02	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Links between parent/subclaims and reports/studies	Material needed: Links between efficacy/safety reports, cohorts, actual interventions, analysis populations and time points are needed. Material-item counts are not unique-trial or participant counts or quality scores. This records needed materials; no new research was executed.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionWhich materials were actually read?Required	The complete stored parent-verdict summary was read for production and an exact whole-byte copy preserved. External abstracts, full texts, registration, protocols and SAPs remain unread. URLs or PMCIDs are not treated as verification of reading, access or condition fulfillment. R01 R02	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Distinguishing the complete stored parent summary from external material	Material needed: Acquisition and reading records for actual full texts, supplements, plans and registration materials are needed. External source-link access and operation were not tested. This records needed materials; no new research was executed.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionWhere are citation and registration identifiers recorded?Required	The 2026 efficacy citation has PMID42621560, PMCID PMC13489564 and DOI10.4103/ijpvm.ijpvm_254_24. The 2016 supporting citation has PMID27761216, PMCID PMC5070040 and DOI10.4103/2008-7802.191865. Neither citation/evidence record contains a separate registration identifier. R01 R02	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	PMID, PMCID and DOI for each citation	Material needed: Exact original bibliographic, study and registration identifiers, content and dates are needed. Full-text or registration URLs are not newly inferred from a PMCID. This records needed materials; no new research was executed.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionAre historical bilingual and cross-check records distinguished from this review?Required	Bilingual text, subclaims, notes and historical Codex PubMed/PMC/scoring checks and verification statements in citation summaries are preserved. This production uses stored summaries; external material is unread and existing content, model and claim-boundary reviews remain incomplete. R01 R02	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Original bilingual wording, subclaim records and historical verification	Material needed: Existing review of original text, translation, corrections and claim boundaries is needed. Historical verification is not presented as completed current clinical review, new calculations or independence certification. This records needed materials; no new research was executed.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionAre the subclaim record and parent C50/axes distinguished?Required	The selected original grade/note and absent score, status and axes are retained. Parent C50, Caution, B/S/R1/I2/EX/B2 and unrecorded precision are parent context. They do not fill the selected MRI liver-fat score or axes or certify independence. R01 R02	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Subclaim grade/note and absent score/status/axes	Material needed: Existing review of the selected subclaim and original parent values is needed. No new score, axes, efficacy grade or verdict change is created. This records needed materials; no new research was executed.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionAre the original evidence date and empty corrections distinguished from production?Required	Original evidence date2026-09-07, the empty correction array and empty deliberation string are retained. This is not a production or review date or certification that no external corrections exist. R01 R02	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Original evidence date and empty correction/deliberation values	Material needed: Follow-up/correction materials and the complete pre-change original and event history are needed. Absent dates or correction values are not invented. This records needed materials; no new research was executed.
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionAre funding, support, employee authors and analysis roles distinguished?Required	The main funding record reports academic Isfahan University research and no conflicts. It does not mean product support, company-employee authors or company analysis/reporting involvement are all verified. Funding details for the 2016 supporting citation are separately unrecorded. R01 R02	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Company-related items and report-specific verification scope	Material needed: Report-specific funding, COI, product/ingredient support, author affiliations and analysis/publication roles are needed. Parent I2 is not used as new independence certification. This records needed materials; no new research was executed.
22	Unverified	Full text not readStored summary read	N22 · Evidence conditionAre allocation, measurement, missingness and selective-reporting details verified?Required	The main trial used block randomization and records covariate adjustment and limitations of completer-focused analysis. Allocation concealment, blinding, test devices/validity, missingness, covariate prespecification and selective-reporting details remain separately unverified. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Boundaries of block randomization, covariate adjustment and completer analysis	Material needed: Original methods, protocols, SAPs, registration/amendment history, test tables, denominators and models are needed. Design names or objective tests alone do not establish formal RoB/GRADE or completed review. This records needed materials; no new research was executed.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionDoes common lifestyle advice establish actual concurrent exposure?Required	Weight-loss-diet and physical-activity advice common to both arms is an original condition. Actual diet, activity, weight changes, medication, product exposure, adherence and withdrawal details remain unverified; their joint contribution is not established. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Weight-loss diet, physical activity, adherence and co-management	Material needed: Actual concurrent exposure, weight, diet, activity, baseline/follow-up medication, exposure, adherence and denominators are needed. No diet, intake or liver-disease-management instructions are created. This records needed materials; no new research was executed.
24	Partly verified	Full text not readStored summary read	N24 · Harm-information gaps supplementing the efficacy tableWhich formulation or group had withdrawals in the supporting safety citation?Supplementary	The 2016 citation reports some withdrawals for constipation, nausea or abdominal pain in a separate NAFLD seed intervention. Exact groups, products, counts, exposure denominators and durations are unverified. All withdrawals are not assigned to the current psyllium10g/day trial. R02	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Links between the 2016 seed intervention, withdrawals and harms	Material needed: That report's formulations, ingredients, group-specific events, withdrawals, reasons, durations, harm collection and exposure denominators are needed. A different safety citation is not converted into independent efficacy replication or the original trial's harm rate. This records needed materials; no new research was executed.
25	Unverified	Full text not readStored summary read	N25 · Harm-information gaps supplementing the efficacy tableAre caution statements, observed harms and long-term safety the same?Supplementary	Potential gas, bloating, abdominal pain, constipation or nausea and swallowing, narrowing and obstruction boundaries are existing safety statements. Harm collection, group-specific events, exposure denominators, CIs, long-term and rare harms remain separately unverified. Original adequate-fluid wording is preserved without creating new fluid quantities, intake methods or treatment advice. R01 R02	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Potential harms, collection methods, denominators and specific risk groups	Material needed: Report-specific harm definitions, active collection, group exposure, denominators, withdrawals, attrition and long-term risk-group data are needed. Caution is not converted into safety, no harm or a new established incidence rate. This records needed materials; no new research was executed.
26	Partly verified	Full text not readStored summary read	N26 · Evidence conditionWhich new materials would prompt an update to this table?Required	This table transfers the stored MRI liver-fat summary. Related observations can be updated after review of original tables, actual test measures/units, direct imaging, histology, clinical endpoints, between-group effects, denominators, concurrent exposures and harms. R01 R02	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Separate records for original materials, conditions, observations and verdict changes	Material needed: The complete pre-change original, original materials, condition versions, separate application and change-decision records are needed. No new clinical research, calculation, regrading, independence certification, intake, diet, liver-disease-management or treatment-replacement advice is created. This records needed materials; no new research was executed.

No items match your search or filter.

26 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-09-07
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: 80 adults with overweight or obesity and MASLD were randomized; 78 completed. Group/test denominators and detailed eligibility are unverified.
Ingredient, formulation and route: Psyllium 10 g/day added to a weight-loss diet and physical-activity advice
Dose: Psyllium10g/day and ten weeks identify the original study. No new total quantities, product, intake, diet or liver-disease-management advice is created.
Comparator: Ground wheat10g/day. Both groups received the same weight-loss-diet and physical-activity advice. Actual concurrent exposure and adherence details are unverified.
Measured outcome: MRI liver fat was not directly measured. ALT, FibroScan and AST, MRS, other imaging and histology are distinguished separately.
Duration: A ten-week efficacy trial. MRI was not directly measured; post-trial follow-up and direct long-term clinical evidence are unverified.
Questions outside this scope: Transferring ALT/FibroScan findings into direct MRI/MRS or histologic liver-fat outcomes; Combining null AST and unmeasured MRI into the same zero-effect claim; Deriving exact between-group effects/CIs, fibrosis reversal, disease improvement or event prevention from P values; Certifying common advice as identical actual diet/activity/weight or psyllium-alone efficacy; Counting the supporting seed safety citation as identical efficacy replication or copying its harms into the current trial; Adding the same reports, time points, conditions or participants as new independent trials or people; New calculations, hypothetical quantities, grades, independence certification, product intake, diets, liver-disease management or treatment-replacement instructions

Evidence and sources

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

R01 · Akbarzadeh Z, Nourian M, Askari G, Maracy MR, Amani R. Benefit of Psyllium with Weight Loss Diet in Preventing Liver Dysfunction in Overweight or Obese Adults with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). Int J Prev Med. 2026;17:46. PMID: 42621560. PMCID: PMC13489564. DOI: 10.4103/ijpvm.ijpvm_254_24.

PubMed

Material type: Randomized block design comparing psyllium with ground wheat
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/plans remain unread
Findings recorded in the stored summary: ALT P=.006, FibroScan score P=.001; AST P=.98
Record level: Corresponding efficacy summary in the evidence record; directness for MRI/other endpoints is distinguished by condition rows and report roles.
Study overlap and independent replication: The Akbarzadeh2026 report concerns ten-week add-on psyllium ALT/FibroScan signals, null AST and gaps in effect size and endpoint hierarchy; MRI was not directly measured. The Akbarian2016 citation provides supporting harm/withdrawal information from a separate NAFLD seed-intervention/anthropometric study; it is not replication of current ALT/FibroScan/MRI efficacy. Parent2985 and both existing subclaims share these citations. Tables or tests, conditions and time points from the same participants are not added as new independent trials or people. Different citations do not certify unique trials or independence; unique-trial and total unique-participant counts remain unverified. Links are provisional by citation and actual cohort/independent-study relationships remain unreviewed.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Local preserved copy of the complete parent summary	Stored summary read	Summary read	Only original PubMed links, PMCIDs and absent/unverified registration information are preserved. No new reading, access, prespecification or verification is certified. Full-text or registration URLs are not inferred.
External abstract	Original citation links or required-material slots; external public/access status unverified	Unread; access not attempted	Not read	Only original PubMed links, PMCIDs and absent/unverified registration information are preserved. No new reading, access, prespecification or verification is certified. Full-text or registration URLs are not inferred.
External full text	Original citation links or required-material slots; external public/access status unverified	Unread; access not attempted	Not read	Only original PubMed links, PMCIDs and absent/unverified registration information are preserved. No new reading, access, prespecification or verification is certified. Full-text or registration URLs are not inferred.
Original registration	Original citation links or required-material slots; external public/access status unverified	Unread; access not attempted	Not read	Only original PubMed links, PMCIDs and absent/unverified registration information are preserved. No new reading, access, prespecification or verification is certified. Full-text or registration URLs are not inferred.
Original protocol	Original citation links or required-material slots; external public/access status unverified	Unread; access not attempted	Not read	Only original PubMed links, PMCIDs and absent/unverified registration information are preserved. No new reading, access, prespecification or verification is certified. Full-text or registration URLs are not inferred.

R02 · Akbarian SA, Asgary S, Feizi A, Iraj B, Askari G. Comparative Study on the Effect of Plantago psyllium and Ocimum basilicum Seeds on Anthropometric Measures in Nonalcoholic Fatty Liver Patients. Int J Prev Med. 2016;7:114. PMID: 27761216. PMCID: PMC5070040. DOI: 10.4103/2008-7802.191865.

PubMed

Material type: Supporting safety citation from a separate seed-intervention and anthropometric study
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/plans remain unread
Findings recorded in the stored summary: Some participants withdrew because of constipation, nausea or abdominal pain in a separate NAFLD seed-intervention trial.
Record level: Supporting safety citation; exact groups, formulations, counts, effects and harm denominators are unverified.
Study overlap and independent replication: The Akbarzadeh2026 report concerns ten-week add-on psyllium ALT/FibroScan signals, null AST and gaps in effect size and endpoint hierarchy; MRI was not directly measured. The Akbarian2016 citation provides supporting harm/withdrawal information from a separate NAFLD seed-intervention/anthropometric study; it is not replication of current ALT/FibroScan/MRI efficacy. Parent2985 and both existing subclaims share these citations. Tables or tests, conditions and time points from the same participants are not added as new independent trials or people. Different citations do not certify unique trials or independence; unique-trial and total unique-participant counts remain unverified. Links are provisional by citation and actual cohort/independent-study relationships remain unreviewed.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Local preserved copy of the complete parent summary	Stored summary read	Summary read	Only original PubMed links, PMCIDs and absent/unverified registration information are preserved. No new reading, access, prespecification or verification is certified. Full-text or registration URLs are not inferred.
External abstract	Original citation links or required-material slots; external public/access status unverified	Unread; access not attempted	Not read	Only original PubMed links, PMCIDs and absent/unverified registration information are preserved. No new reading, access, prespecification or verification is certified. Full-text or registration URLs are not inferred.
External full text	Original citation links or required-material slots; external public/access status unverified	Unread; access not attempted	Not read	Only original PubMed links, PMCIDs and absent/unverified registration information are preserved. No new reading, access, prespecification or verification is certified. Full-text or registration URLs are not inferred.
Original registration	Original citation links or required-material slots; external public/access status unverified	Unread; access not attempted	Not read	Only original PubMed links, PMCIDs and absent/unverified registration information are preserved. No new reading, access, prespecification or verification is certified. Full-text or registration URLs are not inferred.
Original protocol	Original citation links or required-material slots; external public/access status unverified	Unread; access not attempted	Not read	Only original PubMed links, PMCIDs and absent/unverified registration information are preserved. No new reading, access, prespecification or verification is certified. Full-text or registration URLs are not inferred.

Report counts versus independent study counts

The Akbarzadeh2026 report concerns ten-week add-on psyllium ALT/FibroScan signals, null AST and gaps in effect size and endpoint hierarchy; MRI was not directly measured. The Akbarian2016 citation provides supporting harm/withdrawal information from a separate NAFLD seed-intervention/anthropometric study; it is not replication of current ALT/FibroScan/MRI efficacy. Parent2985 and both existing subclaims share these citations. Tables or tests, conditions and time points from the same participants are not added as new independent trials or people. Different citations do not certify unique trials or independence; unique-trial and total unique-participant counts remain unverified. Links are provisional by citation and actual cohort/independent-study relationships remain unreviewed.

Review criteria

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

N01 · Which MRI claim is selected?

Required materials and conditions: The existing MRI liver-fat-reduction claim and verdict record
Conditions for verification: Material for The existing MRI liver-fat-reduction claim and verdict record must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Requirement and applicability: Required
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Why this condition is needed: This condition connects The existing MRI liver-fat-reduction claim and verdict record with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N02 · Was MRI liver fat directly measured?

Required materials and conditions: Unmeasured MRI and the direct-evidence gap
Conditions for verification: Material for Unmeasured MRI and the direct-evidence gap must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Requirement and applicability: Required
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Why this condition is needed: This condition connects Unmeasured MRI and the direct-evidence gap with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N03 · Does ALT P=.006 establish an MRI liver-fat effect?

Required materials and conditions: Distinguishing liver enzymes from a direct MRI endpoint
Conditions for verification: Material for Distinguishing liver enzymes from a direct MRI endpoint must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Requirement and applicability: Required
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Why this condition is needed: This condition connects Distinguishing liver enzymes from a direct MRI endpoint with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N04 · Is FibroScan P=.001 the same measurement as MRI?

Required materials and conditions: Distinguishing the actual FibroScan measure from MRI methods
Conditions for verification: Material for Distinguishing the actual FibroScan measure from MRI methods must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Requirement and applicability: Required
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Why this condition is needed: This condition connects Distinguishing the actual FibroScan measure from MRI methods with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N05 · Are MRI, MRS, other imaging and histologic outcomes individually verified?

Required materials and conditions: Actual measurement by each imaging method and histologic indicator
Conditions for verification: Material for Actual measurement by each imaging method and histologic indicator must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Requirement and applicability: Required
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Why this condition is needed: This condition connects Actual measurement by each imaging method and histologic indicator with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N06 · Does the null AST result establish a null MRI fat result?

Required materials and conditions: Distinguishing AST P=.98 from other unmeasured tests
Conditions for verification: Material for Distinguishing AST P=.98 from other unmeasured tests must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Requirement and applicability: Required
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Why this condition is needed: This condition connects Distinguishing AST P=.98 from other unmeasured tests with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N07 · Are clinical liver-disease outcomes and MRI measurements the same endpoint?

Required materials and conditions: Clinical outcomes such as cirrhosis or hospitalization and direct MRI evidence
Conditions for verification: Material for Clinical outcomes such as cirrhosis or hospitalization and direct MRI evidence must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Requirement and applicability: Required
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Why this condition is needed: This condition connects Clinical outcomes such as cirrhosis or hospitalization and direct MRI evidence with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N08 · Is the MASLD population the same as the separate NAFLD seed trial?

Required materials and conditions: Distinguishing the overweight/obese MASLD population from another seed trial
Conditions for verification: Material for Distinguishing the overweight/obese MASLD population from another seed trial must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Requirement and applicability: Required
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Why this condition is needed: This condition connects Distinguishing the overweight/obese MASLD population from another seed trial with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N09 · Can common diet advice and comparator conditions substitute for MRI effects?

Required materials and conditions: The psyllium versus ground-wheat comparison and common lifestyle advice
Conditions for verification: Material for The psyllium versus ground-wheat comparison and common lifestyle advice must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Requirement and applicability: Required
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Why this condition is needed: This condition connects The psyllium versus ground-wheat comparison and common lifestyle advice with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N10 · Are 80 randomized and 78 completed MRI measurement denominators?

Required materials and conditions: Distinguishing randomized/completed counts from an unmeasured endpoint denominator
Conditions for verification: Material for Distinguishing randomized/completed counts from an unmeasured endpoint denominator must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Requirement and applicability: Required
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Why this condition is needed: This condition connects Distinguishing randomized/completed counts from an unmeasured endpoint denominator with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N11 · Does ten-week study exposure show sustained MRI effects?

Required materials and conditions: Duration, actual exposure and post-trial follow-up
Conditions for verification: Material for Duration, actual exposure and post-trial follow-up must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Requirement and applicability: Required
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Why this condition is needed: This condition connects Duration, actual exposure and post-trial follow-up with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N12 · Did registration or the prespecified endpoint hierarchy include MRI?

Required materials and conditions: Distinguishing unverified registration/prespecified endpoints from unmeasured MRI
Conditions for verification: Material for Distinguishing unverified registration/prespecified endpoints from unmeasured MRI must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Requirement and applicability: Required
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Why this condition is needed: This condition connects Distinguishing unverified registration/prespecified endpoints from unmeasured MRI with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N13 · Can P values from other tests fill MRI effects or CIs?

Required materials and conditions: Direct estimates, within/between-group comparisons and unmeasured outcomes
Conditions for verification: Material for Direct estimates, within/between-group comparisons and unmeasured outcomes must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Requirement and applicability: Required
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Why this condition is needed: This condition connects Direct estimates, within/between-group comparisons and unmeasured outcomes with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N14 · What direct evidence would address the MRI gap?

Required materials and conditions: MRI measurements addressing the same question
Conditions for verification: Material for MRI measurements addressing the same question must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Requirement and applicability: Required
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Why this condition is needed: This condition connects MRI measurements addressing the same question with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N15 · Are the same reports, participants or time points counted as independent evidence?

Required materials and conditions: Links between parent/subclaims and reports/studies
Conditions for verification: Material for Links between parent/subclaims and reports/studies must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Requirement and applicability: Required
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Why this condition is needed: This condition connects Links between parent/subclaims and reports/studies with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N16 · Which materials were actually read?

Required materials and conditions: Distinguishing the complete stored parent summary from external material
Conditions for verification: Material for Distinguishing the complete stored parent summary from external material must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Requirement and applicability: Required
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Why this condition is needed: This condition connects Distinguishing the complete stored parent summary from external material with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N17 · Where are citation and registration identifiers recorded?

Required materials and conditions: PMID, PMCID and DOI for each citation
Conditions for verification: Material for PMID, PMCID and DOI for each citation must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Requirement and applicability: Required
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Why this condition is needed: This condition connects PMID, PMCID and DOI for each citation with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N18 · Are historical bilingual and cross-check records distinguished from this review?

Required materials and conditions: Original bilingual wording, subclaim records and historical verification
Conditions for verification: Material for Original bilingual wording, subclaim records and historical verification must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Requirement and applicability: Required
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Why this condition is needed: This condition connects Original bilingual wording, subclaim records and historical verification with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N19 · Are the subclaim record and parent C50/axes distinguished?

Required materials and conditions: Subclaim grade/note and absent score/status/axes
Conditions for verification: Material for Subclaim grade/note and absent score/status/axes must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Requirement and applicability: Required
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Why this condition is needed: This condition connects Subclaim grade/note and absent score/status/axes with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N20 · Are the original evidence date and empty corrections distinguished from production?

Required materials and conditions: Original evidence date and empty correction/deliberation values
Conditions for verification: Material for Original evidence date and empty correction/deliberation values must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Requirement and applicability: Required
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Why this condition is needed: This condition connects Original evidence date and empty correction/deliberation values with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N21 · Are funding, support, employee authors and analysis roles distinguished?

Required materials and conditions: Company-related items and report-specific verification scope
Conditions for verification: Material for Company-related items and report-specific verification scope must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Requirement and applicability: Required
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Why this condition is needed: This condition connects Company-related items and report-specific verification scope with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N22 · Are allocation, measurement, missingness and selective-reporting details verified?

Required materials and conditions: Boundaries of block randomization, covariate adjustment and completer analysis
Conditions for verification: Material for Boundaries of block randomization, covariate adjustment and completer analysis must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Requirement and applicability: Required
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Why this condition is needed: This condition connects Boundaries of block randomization, covariate adjustment and completer analysis with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N23 · Does common lifestyle advice establish actual concurrent exposure?

Required materials and conditions: Weight-loss diet, physical activity, adherence and co-management
Conditions for verification: Material for Weight-loss diet, physical activity, adherence and co-management must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Requirement and applicability: Required
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Why this condition is needed: This condition connects Weight-loss diet, physical activity, adherence and co-management with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N24 · Which formulation or group had withdrawals in the supporting safety citation?

Required materials and conditions: Links between the 2016 seed intervention, withdrawals and harms
Conditions for verification: Material for Links between the 2016 seed intervention, withdrawals and harms must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Requirement and applicability: Supplementary
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Why this condition is needed: This condition connects Links between the 2016 seed intervention, withdrawals and harms with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N25 · Are caution statements, observed harms and long-term safety the same?

Required materials and conditions: Potential harms, collection methods, denominators and specific risk groups
Conditions for verification: Material for Potential harms, collection methods, denominators and specific risk groups must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Requirement and applicability: Supplementary
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Why this condition is needed: This condition connects Potential harms, collection methods, denominators and specific risk groups with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N26 · Which new materials would prompt an update to this table?

Required materials and conditions: Separate records for original materials, conditions, observations and verdict changes
Conditions for verification: Material for Separate records for original materials, conditions, observations and verdict changes must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Requirement and applicability: Required
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Why this condition is needed: This condition connects Separate records for original materials, conditions, observations and verdict changes with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Referenced methods and the sections actually reviewed

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

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

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

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

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

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

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

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

What the statuses mean

Partly verified: Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.
Unverified: Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety
Review incomplete: Review of existing content incomplete
Met: Use only within the relevant conditions after existing content review; no automatic designation in this preparation
Not reported: Distinguish only within materials actually read; do not turn unread external materials into unreported findings
Inaccessible: Not applied during this preparation because actual access was not tested
Not applicable: Use with a reason for non-applicability based on an explicit question boundary
Conflicting data: Judge after actual material comparison; review was not performed during this preparation
Insufficient evidence for the conditions: Do not use as a clinical grade encompassing currently unread materials

Change history

2026-10-16 · Public page/material version 1.0

The reader view and materials were prepared from the existing 26 items. No new clinical search, verification-status changes or scoring were performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-09-07) were retained unchanged.

Researcher downloads

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

View all item details

N01 · Which MRI claim is selected?

Current findings: The selected claim is reduced MRI-measured liver fat. Its original grade is ? and its note says this was not an outcome measured by the trial. Subclaim score, status and axes are unrecorded and distinguished from the parent ALT/FibroScan verdict C50.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Definitions, population, comparator, time points and denominators for direct MRI measurement, and review of the existing claim boundary, are needed. The ? does not mean zero effect, zero points or absence of all human research.
Required materials and conditions: The existing MRI liver-fat-reduction claim and verdict record
Materials to obtain first: Definitions, population, comparator, time points and denominators for direct MRI measurement, and review of the existing claim boundary, are needed. The ? does not mean zero effect, zero points or absence of all human research.
Further research: Material needed: Definitions, population, comparator, time points and denominators for direct MRI measurement, and review of the existing claim boundary, are needed. The ? does not mean zero effect, zero points or absence of all human research. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for The existing MRI liver-fat-reduction claim and verdict record must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Why this condition is needed: This condition connects The existing MRI liver-fat-reduction claim and verdict record with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N02 · Was MRI liver fat directly measured?

Current findings: The existing crux, summary note and subclaim note record that the trial did not measure MRI liver fat. MRI values, between-group changes, CIs and measurement denominators are not filled using ALT/FibroScan findings.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Actual MRI liver-fat methods, quantification, units, baseline and follow-up measurements, comparator, denominators and CIs are needed. An unmeasured outcome is not a test showing no effect.
Required materials and conditions: Unmeasured MRI and the direct-evidence gap
Materials to obtain first: Actual MRI liver-fat methods, quantification, units, baseline and follow-up measurements, comparator, denominators and CIs are needed. An unmeasured outcome is not a test showing no effect.
Further research: Material needed: Actual MRI liver-fat methods, quantification, units, baseline and follow-up measurements, comparator, denominators and CIs are needed. An unmeasured outcome is not a test showing no effect. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Unmeasured MRI and the direct-evidence gap must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Why this condition is needed: This condition connects Unmeasured MRI and the direct-evidence gap with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N03 · Does ALT P=.006 establish an MRI liver-fat effect?

Current findings: Original ALT P=.006 is a covariate-adjusted liver-enzyme result, not MRI fat quantity, change or a CI. It is not converted into an MRI liver-fat-reduction effect or amount of normalization.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Original ALT tables and separate direct MRI data, definitions, models, denominators and CIs are needed. Original P values are preserved without new effect or fat-quantity calculations.
Required materials and conditions: Distinguishing liver enzymes from a direct MRI endpoint
Materials to obtain first: Original ALT tables and separate direct MRI data, definitions, models, denominators and CIs are needed. Original P values are preserved without new effect or fat-quantity calculations.
Further research: Material needed: Original ALT tables and separate direct MRI data, definitions, models, denominators and CIs are needed. Original P values are preserved without new effect or fat-quantity calculations. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Distinguishing liver enzymes from a direct MRI endpoint must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Why this condition is needed: This condition connects Distinguishing liver enzymes from a direct MRI endpoint with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N04 · Is FibroScan P=.001 the same measurement as MRI?

Current findings: The original wording of FibroScan fibrosis score P=.001 and the existing explanation that it differs from MRI are preserved. Actual measure, units and device algorithm are unverified and are not converted into MRI fat quantity.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: FibroScan definitions and valid measurements, direct MRI quantification methods, and their respective denominators, models and CIs are needed. A device name alone does not establish fat measurement or histologic effects.
Required materials and conditions: Distinguishing the actual FibroScan measure from MRI methods
Materials to obtain first: FibroScan definitions and valid measurements, direct MRI quantification methods, and their respective denominators, models and CIs are needed. A device name alone does not establish fat measurement or histologic effects.
Further research: Material needed: FibroScan definitions and valid measurements, direct MRI quantification methods, and their respective denominators, models and CIs are needed. A device name alone does not establish fat measurement or histologic effects. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Distinguishing the actual FibroScan measure from MRI methods must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Why this condition is needed: This condition connects Distinguishing the actual FibroScan measure from MRI methods with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N05 · Are MRI, MRS, other imaging and histologic outcomes individually verified?

Current findings: The existing advertising analysis cautions against adding unmeasured MRI or histologic liver-fat findings. Detailed MRS, other imaging and histologic results and values are also not verified as separate direct outcomes in the stored summary.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Actual performance, purpose, definitions, units, time points, denominators and CIs for each method or histologic measure are needed. Unverified information is not replaced with confirmed performance or a zero result.
Required materials and conditions: Actual measurement by each imaging method and histologic indicator
Materials to obtain first: Actual performance, purpose, definitions, units, time points, denominators and CIs for each method or histologic measure are needed. Unverified information is not replaced with confirmed performance or a zero result.
Further research: Material needed: Actual performance, purpose, definitions, units, time points, denominators and CIs for each method or histologic measure are needed. Unverified information is not replaced with confirmed performance or a zero result. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Actual measurement by each imaging method and histologic indicator must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Why this condition is needed: This condition connects Actual measurement by each imaging method and histologic indicator with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N06 · Does the null AST result establish a null MRI fat result?

Current findings: AST P=.98 is the original null liver-enzyme test result. It is not transferred into zero MRI effect or equivalence for an unmeasured outcome, or obscured by favorable ALT findings.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Test-specific values, denominators, between-group effects, CIs, prespecified hierarchy and separate MRI data are needed. No new conversion between tests is made.
Required materials and conditions: Distinguishing AST P=.98 from other unmeasured tests
Materials to obtain first: Test-specific values, denominators, between-group effects, CIs, prespecified hierarchy and separate MRI data are needed. No new conversion between tests is made.
Further research: Material needed: Test-specific values, denominators, between-group effects, CIs, prespecified hierarchy and separate MRI data are needed. No new conversion between tests is made. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Distinguishing AST P=.98 from other unmeasured tests must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Why this condition is needed: This condition connects Distinguishing AST P=.98 from other unmeasured tests with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N07 · Are clinical liver-disease outcomes and MRI measurements the same endpoint?

Current findings: The Korean text says whether marker changes lead to cirrhosis or hospitalization is unknown; the English text says clinical liver events were not tested. MRI fat quantity is also distinct from clinical-event effects and was not directly measured in this trial.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Clinical-event definitions, adjudication, long-term follow-up, group-specific time at risk, denominators, effects, CIs and direct MRI data are needed. No conversion into zero events or treatment efficacy is made.
Required materials and conditions: Clinical outcomes such as cirrhosis or hospitalization and direct MRI evidence
Materials to obtain first: Clinical-event definitions, adjudication, long-term follow-up, group-specific time at risk, denominators, effects, CIs and direct MRI data are needed. No conversion into zero events or treatment efficacy is made.
Further research: Material needed: Clinical-event definitions, adjudication, long-term follow-up, group-specific time at risk, denominators, effects, CIs and direct MRI data are needed. No conversion into zero events or treatment efficacy is made. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Clinical outcomes such as cirrhosis or hospitalization and direct MRI evidence must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Why this condition is needed: This condition connects Clinical outcomes such as cirrhosis or hospitalization and direct MRI evidence with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N08 · Is the MASLD population the same as the separate NAFLD seed trial?

Current findings: The main trial involved 80 adults with overweight or obesity and MASLD. The 2016 supporting safety citation concerns NAFLD seed intervention and anthropometry. Differences in diagnosis, disease stage, baseline imaging, medication and formulation are not merged into evidence for the same MRI efficacy question.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Report-specific populations, diagnoses, baseline imaging, liver disease, medication, interventions, durations and direct MRI evidence are needed. No generalization to every liver disease or formulation is made.
Required materials and conditions: Distinguishing the overweight/obese MASLD population from another seed trial
Materials to obtain first: Report-specific populations, diagnoses, baseline imaging, liver disease, medication, interventions, durations and direct MRI evidence are needed. No generalization to every liver disease or formulation is made.
Further research: Material needed: Report-specific populations, diagnoses, baseline imaging, liver disease, medication, interventions, durations and direct MRI evidence are needed. No generalization to every liver disease or formulation is made. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Distinguishing the overweight/obese MASLD population from another seed trial must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Why this condition is needed: This condition connects Distinguishing the overweight/obese MASLD population from another seed trial with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02

N09 · Can common diet advice and comparator conditions substitute for MRI effects?

Current findings: The 10g/day interventions, ground-wheat comparator, weight-loss diet and physical-activity advice in both groups are original study conditions. Common advice or weight changes are not assumed to establish MRI liver-fat improvement, an isolated effect or a comparison with no treatment.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Actual diet, activity, weight, medication, adherence, comparator, exposure and direct MRI measurement data are needed. No new diet, liver-disease-management or intake advice is created.
Required materials and conditions: The psyllium versus ground-wheat comparison and common lifestyle advice
Materials to obtain first: Actual diet, activity, weight, medication, adherence, comparator, exposure and direct MRI measurement data are needed. No new diet, liver-disease-management or intake advice is created.
Further research: Material needed: Actual diet, activity, weight, medication, adherence, comparator, exposure and direct MRI measurement data are needed. No new diet, liver-disease-management or intake advice is created. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for The psyllium versus ground-wheat comparison and common lifestyle advice must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Why this condition is needed: This condition connects The psyllium versus ground-wheat comparison and common lifestyle advice with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N10 · Are 80 randomized and 78 completed MRI measurement denominators?

Current findings: 80 randomized and 78 completed describe participation in the main trial, not numbers or denominators measured by MRI. Time points, tests and report counts are not added as independent trials or participants.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Group-specific randomization, valid scans, missingness, analysis flow, effects and CIs from direct MRI research are needed. No new valid MRI denominator, dropout count or dropout rate is calculated.
Required materials and conditions: Distinguishing randomized/completed counts from an unmeasured endpoint denominator
Materials to obtain first: Group-specific randomization, valid scans, missingness, analysis flow, effects and CIs from direct MRI research are needed. No new valid MRI denominator, dropout count or dropout rate is calculated.
Further research: Material needed: Group-specific randomization, valid scans, missingness, analysis flow, effects and CIs from direct MRI research are needed. No new valid MRI denominator, dropout count or dropout rate is calculated. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Distinguishing randomized/completed counts from an unmeasured endpoint denominator must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Why this condition is needed: This condition connects Distinguishing randomized/completed counts from an unmeasured endpoint denominator with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N11 · Does ten-week study exposure show sustained MRI effects?

Current findings: Ten weeks, psyllium10g/day and ground wheat10g/day identify the original efficacy trial. With MRI unmeasured, no ten-week MRI effect, persistence, subsequent fat quantity or long-term safety is created.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Direct MRI baseline, follow-up and post-trial data, actual exposure, denominators, comparator and duration are needed. No product-intake, maintenance or treatment-replacement instructions are created.
Required materials and conditions: Duration, actual exposure and post-trial follow-up
Materials to obtain first: Direct MRI baseline, follow-up and post-trial data, actual exposure, denominators, comparator and duration are needed. No product-intake, maintenance or treatment-replacement instructions are created.
Further research: Material needed: Direct MRI baseline, follow-up and post-trial data, actual exposure, denominators, comparator and duration are needed. No product-intake, maintenance or treatment-replacement instructions are created. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Duration, actual exposure and post-trial follow-up must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Why this condition is needed: This condition connects Duration, actual exposure and post-trial follow-up with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N12 · Did registration or the prespecified endpoint hierarchy include MRI?

Current findings: The original record leaves effect size, prespecified primary-endpoint hierarchy and registration unverified; MRI was not a measured endpoint. Registration identifiers or plans are not invented to verify MRI as a prespecified or later endpoint.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Original registration and amendment history, protocols, SAPs, actual endpoints, time points and direct MRI design data are needed. External registration and planning materials remain unread.
Required materials and conditions: Distinguishing unverified registration/prespecified endpoints from unmeasured MRI
Materials to obtain first: Original registration and amendment history, protocols, SAPs, actual endpoints, time points and direct MRI design data are needed. External registration and planning materials remain unread.
Further research: Material needed: Original registration and amendment history, protocols, SAPs, actual endpoints, time points and direct MRI design data are needed. External registration and planning materials remain unread. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Distinguishing unverified registration/prespecified endpoints from unmeasured MRI must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Why this condition is needed: This condition connects Distinguishing unverified registration/prespecified endpoints from unmeasured MRI with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N13 · Can P values from other tests fill MRI effects or CIs?

Current findings: MRI values, direct effects and CIs remain a gap because MRI was not measured. Covariate-adjusted ALT/FibroScan P values and the parent verdict's interpretation do not provide quantitative MRI evidence.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Direct MRI group values, baseline, changes, adjusted estimates, 95%CIs, units, denominators and clinical importance are needed. No new calculations, hypothetical examples or effect sizes are created.
Required materials and conditions: Direct estimates, within/between-group comparisons and unmeasured outcomes
Materials to obtain first: Direct MRI group values, baseline, changes, adjusted estimates, 95%CIs, units, denominators and clinical importance are needed. No new calculations, hypothetical examples or effect sizes are created.
Further research: Material needed: Direct MRI group values, baseline, changes, adjusted estimates, 95%CIs, units, denominators and clinical importance are needed. No new calculations, hypothetical examples or effect sizes are created. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Direct estimates, within/between-group comparisons and unmeasured outcomes must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Why this condition is needed: This condition connects Direct estimates, within/between-group comparisons and unmeasured outcomes with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N14 · What direct evidence would address the MRI gap?

Current findings: The current record contains selected ten-week liver-test signals and unmeasured MRI. Other surrogates or the separate seed safety citation do not fill this gap; needed direct MRI materials are identified.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: MRI liver-fat methods, baseline, follow-up, denominators, effects, CIs, actual exposure and harms for the same formulation, common advice, comparator and selected MASLD population are needed. Only research needs are recorded; no new research, calculation or regrading is performed.
Required materials and conditions: MRI measurements addressing the same question
Materials to obtain first: MRI liver-fat methods, baseline, follow-up, denominators, effects, CIs, actual exposure and harms for the same formulation, common advice, comparator and selected MASLD population are needed. Only research needs are recorded; no new research, calculation or regrading is performed.
Further research: Material needed: MRI liver-fat methods, baseline, follow-up, denominators, effects, CIs, actual exposure and harms for the same formulation, common advice, comparator and selected MASLD population are needed. Only research needs are recorded; no new research, calculation or regrading is performed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for MRI measurements addressing the same question must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Why this condition is needed: This condition connects MRI measurements addressing the same question with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N15 · Are the same reports, participants or time points counted as independent evidence?

Current findings: Parent2985 and the ALT/FibroScan and MRI sheets share the Akbarzadeh2026 efficacy-trial context and Akbarian2016 supporting safety citation. Tests, conditions and time points from the same participants are not added as new independent trials or people. Unique-trial and total unique-participant counts remain unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Links between efficacy/safety reports, cohorts, actual interventions, analysis populations and time points are needed. Material-item counts are not unique-trial or participant counts or quality scores.
Required materials and conditions: Links between parent/subclaims and reports/studies
Materials to obtain first: Links between efficacy/safety reports, cohorts, actual interventions, analysis populations and time points are needed. Material-item counts are not unique-trial or participant counts or quality scores.
Further research: Material needed: Links between efficacy/safety reports, cohorts, actual interventions, analysis populations and time points are needed. Material-item counts are not unique-trial or participant counts or quality scores. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Links between parent/subclaims and reports/studies must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Why this condition is needed: This condition connects Links between parent/subclaims and reports/studies with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02

N16 · Which materials were actually read?

Current findings: The complete stored parent-verdict summary was read for production and an exact whole-byte copy preserved. External abstracts, full texts, registration, protocols and SAPs remain unread. URLs or PMCIDs are not treated as verification of reading, access or condition fulfillment.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Acquisition and reading records for actual full texts, supplements, plans and registration materials are needed. External source-link access and operation were not tested.
Required materials and conditions: Distinguishing the complete stored parent summary from external material
Materials to obtain first: Acquisition and reading records for actual full texts, supplements, plans and registration materials are needed. External source-link access and operation were not tested.
Further research: Material needed: Acquisition and reading records for actual full texts, supplements, plans and registration materials are needed. External source-link access and operation were not tested. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Distinguishing the complete stored parent summary from external material must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Why this condition is needed: This condition connects Distinguishing the complete stored parent summary from external material with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02

N17 · Where are citation and registration identifiers recorded?

Current findings: The 2026 efficacy citation has PMID42621560, PMCID PMC13489564 and DOI10.4103/ijpvm.ijpvm_254_24. The 2016 supporting citation has PMID27761216, PMCID PMC5070040 and DOI10.4103/2008-7802.191865. Neither citation/evidence record contains a separate registration identifier.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Exact original bibliographic, study and registration identifiers, content and dates are needed. Full-text or registration URLs are not newly inferred from a PMCID.
Required materials and conditions: PMID, PMCID and DOI for each citation
Materials to obtain first: Exact original bibliographic, study and registration identifiers, content and dates are needed. Full-text or registration URLs are not newly inferred from a PMCID.
Further research: Material needed: Exact original bibliographic, study and registration identifiers, content and dates are needed. Full-text or registration URLs are not newly inferred from a PMCID. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for PMID, PMCID and DOI for each citation must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Why this condition is needed: This condition connects PMID, PMCID and DOI for each citation with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02

N18 · Are historical bilingual and cross-check records distinguished from this review?

Current findings: Bilingual text, subclaims, notes and historical Codex PubMed/PMC/scoring checks and verification statements in citation summaries are preserved. This production uses stored summaries; external material is unread and existing content, model and claim-boundary reviews remain incomplete.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Existing review of original text, translation, corrections and claim boundaries is needed. Historical verification is not presented as completed current clinical review, new calculations or independence certification.
Required materials and conditions: Original bilingual wording, subclaim records and historical verification
Materials to obtain first: Existing review of original text, translation, corrections and claim boundaries is needed. Historical verification is not presented as completed current clinical review, new calculations or independence certification.
Further research: Material needed: Existing review of original text, translation, corrections and claim boundaries is needed. Historical verification is not presented as completed current clinical review, new calculations or independence certification. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Original bilingual wording, subclaim records and historical verification must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Why this condition is needed: This condition connects Original bilingual wording, subclaim records and historical verification with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02

N19 · Are the subclaim record and parent C50/axes distinguished?

Current findings: The selected original grade/note and absent score, status and axes are retained. Parent C50, Caution, B/S/R1/I2/EX/B2 and unrecorded precision are parent context. They do not fill the selected MRI liver-fat score or axes or certify independence.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Existing review of the selected subclaim and original parent values is needed. No new score, axes, efficacy grade or verdict change is created.
Required materials and conditions: Subclaim grade/note and absent score/status/axes
Materials to obtain first: Existing review of the selected subclaim and original parent values is needed. No new score, axes, efficacy grade or verdict change is created.
Further research: Material needed: Existing review of the selected subclaim and original parent values is needed. No new score, axes, efficacy grade or verdict change is created. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Subclaim grade/note and absent score/status/axes must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Why this condition is needed: This condition connects Subclaim grade/note and absent score/status/axes with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02

N20 · Are the original evidence date and empty corrections distinguished from production?

Current findings: Original evidence date2026-09-07, the empty correction array and empty deliberation string are retained. This is not a production or review date or certification that no external corrections exist.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Follow-up/correction materials and the complete pre-change original and event history are needed. Absent dates or correction values are not invented.
Required materials and conditions: Original evidence date and empty correction/deliberation values
Materials to obtain first: Follow-up/correction materials and the complete pre-change original and event history are needed. Absent dates or correction values are not invented.
Further research: Material needed: Follow-up/correction materials and the complete pre-change original and event history are needed. Absent dates or correction values are not invented. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Original evidence date and empty correction/deliberation values must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Why this condition is needed: This condition connects Original evidence date and empty correction/deliberation values with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02

N21 · Are funding, support, employee authors and analysis roles distinguished?

Current findings: The main funding record reports academic Isfahan University research and no conflicts. It does not mean product support, company-employee authors or company analysis/reporting involvement are all verified. Funding details for the 2016 supporting citation are separately unrecorded.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Report-specific funding, COI, product/ingredient support, author affiliations and analysis/publication roles are needed. Parent I2 is not used as new independence certification.
Required materials and conditions: Company-related items and report-specific verification scope
Materials to obtain first: Report-specific funding, COI, product/ingredient support, author affiliations and analysis/publication roles are needed. Parent I2 is not used as new independence certification.
Further research: Material needed: Report-specific funding, COI, product/ingredient support, author affiliations and analysis/publication roles are needed. Parent I2 is not used as new independence certification. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Company-related items and report-specific verification scope must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Why this condition is needed: This condition connects Company-related items and report-specific verification scope with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02

N22 · Are allocation, measurement, missingness and selective-reporting details verified?

Current findings: The main trial used block randomization and records covariate adjustment and limitations of completer-focused analysis. Allocation concealment, blinding, test devices/validity, missingness, covariate prespecification and selective-reporting details remain separately unverified.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Original methods, protocols, SAPs, registration/amendment history, test tables, denominators and models are needed. Design names or objective tests alone do not establish formal RoB/GRADE or completed review.
Required materials and conditions: Boundaries of block randomization, covariate adjustment and completer analysis
Materials to obtain first: Original methods, protocols, SAPs, registration/amendment history, test tables, denominators and models are needed. Design names or objective tests alone do not establish formal RoB/GRADE or completed review.
Further research: Material needed: Original methods, protocols, SAPs, registration/amendment history, test tables, denominators and models are needed. Design names or objective tests alone do not establish formal RoB/GRADE or completed review. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Boundaries of block randomization, covariate adjustment and completer analysis must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Why this condition is needed: This condition connects Boundaries of block randomization, covariate adjustment and completer analysis with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N23 · Does common lifestyle advice establish actual concurrent exposure?

Current findings: Weight-loss-diet and physical-activity advice common to both arms is an original condition. Actual diet, activity, weight changes, medication, product exposure, adherence and withdrawal details remain unverified; their joint contribution is not established.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Actual concurrent exposure, weight, diet, activity, baseline/follow-up medication, exposure, adherence and denominators are needed. No diet, intake or liver-disease-management instructions are created.
Required materials and conditions: Weight-loss diet, physical activity, adherence and co-management
Materials to obtain first: Actual concurrent exposure, weight, diet, activity, baseline/follow-up medication, exposure, adherence and denominators are needed. No diet, intake or liver-disease-management instructions are created.
Further research: Material needed: Actual concurrent exposure, weight, diet, activity, baseline/follow-up medication, exposure, adherence and denominators are needed. No diet, intake or liver-disease-management instructions are created. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Weight-loss diet, physical activity, adherence and co-management must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Why this condition is needed: This condition connects Weight-loss diet, physical activity, adherence and co-management with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N24 · Which formulation or group had withdrawals in the supporting safety citation?

Current findings: The 2016 citation reports some withdrawals for constipation, nausea or abdominal pain in a separate NAFLD seed intervention. Exact groups, products, counts, exposure denominators and durations are unverified. All withdrawals are not assigned to the current psyllium10g/day trial.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: That report's formulations, ingredients, group-specific events, withdrawals, reasons, durations, harm collection and exposure denominators are needed. A different safety citation is not converted into independent efficacy replication or the original trial's harm rate.
Required materials and conditions: Links between the 2016 seed intervention, withdrawals and harms
Materials to obtain first: That report's formulations, ingredients, group-specific events, withdrawals, reasons, durations, harm collection and exposure denominators are needed. A different safety citation is not converted into independent efficacy replication or the original trial's harm rate.
Further research: Material needed: That report's formulations, ingredients, group-specific events, withdrawals, reasons, durations, harm collection and exposure denominators are needed. A different safety citation is not converted into independent efficacy replication or the original trial's harm rate. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Links between the 2016 seed intervention, withdrawals and harms must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Why this condition is needed: This condition connects Links between the 2016 seed intervention, withdrawals and harms with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R02

N25 · Are caution statements, observed harms and long-term safety the same?

Current findings: Potential gas, bloating, abdominal pain, constipation or nausea and swallowing, narrowing and obstruction boundaries are existing safety statements. Harm collection, group-specific events, exposure denominators, CIs, long-term and rare harms remain separately unverified. Original adequate-fluid wording is preserved without creating new fluid quantities, intake methods or treatment advice.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Report-specific harm definitions, active collection, group exposure, denominators, withdrawals, attrition and long-term risk-group data are needed. Caution is not converted into safety, no harm or a new established incidence rate.
Required materials and conditions: Potential harms, collection methods, denominators and specific risk groups
Materials to obtain first: Report-specific harm definitions, active collection, group exposure, denominators, withdrawals, attrition and long-term risk-group data are needed. Caution is not converted into safety, no harm or a new established incidence rate.
Further research: Material needed: Report-specific harm definitions, active collection, group exposure, denominators, withdrawals, attrition and long-term risk-group data are needed. Caution is not converted into safety, no harm or a new established incidence rate. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Potential harms, collection methods, denominators and specific risk groups must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Why this condition is needed: This condition connects Potential harms, collection methods, denominators and specific risk groups with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02

N26 · Which new materials would prompt an update to this table?

Current findings: This table transfers the stored MRI liver-fat summary. Related observations can be updated after review of original tables, actual test measures/units, direct imaging, histology, clinical endpoints, between-group effects, denominators, concurrent exposures and harms.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: The complete pre-change original, original materials, condition versions, separate application and change-decision records are needed. No new clinical research, calculation, regrading, independence certification, intake, diet, liver-disease-management or treatment-replacement advice is created.
Required materials and conditions: Separate records for original materials, conditions, observations and verdict changes
Materials to obtain first: The complete pre-change original, original materials, condition versions, separate application and change-decision records are needed. No new clinical research, calculation, regrading, independence certification, intake, diet, liver-disease-management or treatment-replacement advice is created.
Further research: Material needed: The complete pre-change original, original materials, condition versions, separate application and change-decision records are needed. No new clinical research, calculation, regrading, independence certification, intake, diet, liver-disease-management or treatment-replacement advice is created. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Separate records for original materials, conditions, observations and verdict changes must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.
Why this condition is needed: This condition connects Separate records for original materials, conditions, observations and verdict changes with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.
Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02