Ultraprocessed or minimally processed diets following healthy dietary guidelines on weight and cardiometabolic health: a randomized, crossover trial
Dicken SJ, Jassil FC, Brown A, Kalis M, Stanley C, Ranson C, Ruwona T, Qamar S, Buck C, Mallik R, Hamid N, Bird JM, Brown A, Norton B, Gandini Wheeler-Kingshott CAM, Hamer M, van Tulleken C, Hall KD, Fisher A, Makaronidis J, Batterham RL.
- DOI
- 10.1038/s41591-025-03842-0
- Record issued
- 2026-08-10
- Engine
- 7.29.0
- Exported
- 2026-09-22
Prepared by Alpha1. This document is confidential: it is intended for the recipient it was shared with and must not be redistributed. The live record at alpha1science.com/verify/23463ec4-1605-4186-8a70-be8feb617291 is authoritative.
How this rating was calculated
- IntegrityIntegrity concern ×2−1★
- ClaimsOverstated claim−0.5★
- ReportingEthical approvals partially met−0.25★
- ReportingKey resources partially met−0.25★
- References were not verified against Crossref/OpenAlex.
- 01Conclusion reaches beyond the evidence
The MPF diet conferred greater cardiometabolic improvements than the UPF diet.
“the greater weight and fat mass reductions on the MPF compared with the UPF diet did not translate into significant improvements in cardiometabolic risk factors over the UPF diet, except triglycerides.”
DiscussionFind in source
This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.
This is a well-designed and transparently reported crossover RCT comparing MPF vs UPF diets within UK dietary guidance. The main methodological strengths are rigorous randomization/blinding, a priori power analysis, comprehensive demographic reporting, prospective registration, and a concrete data/code availability statement. The weaknesses are minor reporting gaps: no explicit Declaration of Helsinki statement, a small arithmetic discrepancy in the eligibility percentage, an internally inconsistent interaction p-value, and a slightly overstated cardiometabolic conclusion.
All three reviewers converged on pass for scientific premise, study design, biological variables, data code availability, and reporting transparency, and on warn for ethical approvals. They diverged on key resources (N/A vs warn vs pass; synthesized to pass) and statistical analysis (warn vs pass; synthesized to warn due to the verifiable percentage error). The statistics component recomputed only 3 reported tests (2 consistent, 0 inconsistent); most p-values were threshold-only or model-derived and could not be machine-verified, so the statistics are not confirmed as a whole. The claim audit flagged one overstated conclusion.
Numerical inconsistencies
1 finding · worst lowValues that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.
- Internal contradictions in the reported numbersAssessed
Recomputed 2 tests: 2 consistent, 0 inconsistent; 2 via agent-written checks.
- CONSISTENTreported p = .024 · recomputed p = .023Reviewers 1, 2Primary outcome: within-participant difference in %WC between MPF and UPF diets (two-sided t-test, df 46.1)
“Within-participant differences in %WC were significantly greater on the MPF versus UPF diet (Δ%WC, −1.01% (s.e., 0.43; 95% CI, −1.87, −0.14; P = 0.024).”
Taken as given: the two-sided t statistic has 46.1 degrees of freedom as stated in the Fig. 2 caption; t = mean difference / standard error = 1.01 / 0.43; the test is two-tailedMethod: Two-tailed t-test p computed as 2*(1-tCdf(t, df)) with t = 1.01/0.43 and df = 46.1; yields ~0.023, consistent with reported 0.024.How we recomputed it: 2*(1-tCdf(1.01/0.43, 46.1)) - CONSISTENTreported p = .024 · recomputed p = .022Reviewer 1Primary outcome p cross-checked from estimate and 95% CI
“Within-participant differences in %WC were significantly greater on the MPF versus UPF diet (Δ%WC, −1.01% (s.e., 0.43; 95% CI, −1.87, −0.14; P = 0.024).”
Taken as given: the 95% CI is two-sided; the estimate -1.01 is the mean within-participant difference in %WC; the CI is on the linear (non-log) scaleMethod: p derived from estimate and two-sided 95% CI via normal approximation (z = estimate/SE); yields ~0.021, close to the reported 0.024 (t-based value is the more faithful check).How we recomputed it: pCI(-1.01, -1.87, -0.14, 0) - UNCOMPUTABLEreported p = .088 · recomputed p = .645Reviewer 2Fisher's exact test for adverse events by diet (participants with no AE)
“AEs did not differ significantly by diet (P = 0.088)”
Taken as given: The 2x2 table is: MPF no AE=14, MPF with AE=36; UPF no AE=11, UPF with AE=39.; The total ITT N=50, and the numbers of participants reporting no AE are 14 and 11 from Table 3.; The test is two-sided Fisher's exact test.; The table cells are counts of participants, not events.Method: Fisher's exact test (two-sided) on the 2x2 contingency table of participants with/without any adverse event by diet.How we recomputed it: pFisher2x2(14,36,11,39,0)
- lowinternal contradictionEligibility percentage inconsistent: 55/135 = 40.7%, but the paper reports 40.1%.
“135 adults underwent screening, of whom 55 (40.1%) were eligible”
ResultsFind in source
Overstated conclusions
2 findings · worst mediumConclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.
- Conclusions overstated beyond the evidenceAssessed
- Conclusions only partially backed by the presented evidenceAssessed
12 major claims checked against the paper's own evidence: 1 not fully backed by the presented evidence (unsupported or overstated).
- overstatedReviewer 1The MPF diet conferred greater cardiometabolic improvements than the UPF diet.Only triglycerides were significantly lower on MPF; LDL-C was significantly lower on UPF, and BP, glucose, lipids and HbA1c mostly did not differ between diets — so a broad 'cardiometabolic improvements' claim outruns the presented evidence.Evidence: Triglycerides −0.25 mmol/l (P=0.004) favoring MPF; LDL-C 0.25 mmol/l (P=0.016) favoring UPF; no significant between-diet differences in BP, glucose, HbA1c or total/HDL cholesterol.
“the greater weight and fat mass reductions on the MPF compared with the UPF diet did not translate into significant improvements in cardiometabolic risk factors over the UPF diet, except triglycerides.”
DiscussionFind in source - partialReviewer 1Maintaining the 8-week weight-loss trajectories over 1 year would yield ~9-13% (MPF) and ~4-5% (UPF) weight loss.This is a speculative extrapolation from 8-week data, explicitly hedged as 'estimated'/'may', so it is presented as a projection rather than an observed result.Evidence: Model-based extrapolation of 8-week trajectories; no 1-year data collected.
“Maintaining the 8-week weight loss trajectories over 1 year may result in an estimated 9–13% and 4–5% weight loss on MPF and UPF diets, respectively”
DiscussionFind in source - partialReviewer 3MPF diet leads to greater improvements in craving control and reductions in cravings for savory and sweet compared to UPF diet.Significant improvements in craving control and craving for savory were observed, but craving for sweet was not significantly different between diets (P=0.055).Evidence: Table 2: CoEQ craving control 11.68 (P=0.019), craving for savory -10.46 (P=0.015), craving for sweet -6.97 (P=0.055).
“Improvements in CoEQ craving for savory (−10.46 (s.e., 4.12); P = 0.015), difficulty to resist craved nominated food (−13.77 (s.e., 6.35); P = 0.037) and craving control (11.68 (s.e., 4.74); P = 0.019) were significantly greater on the MPF than UPF diet.”
ResultsFind in source - supportedReviewer 1The MPF diet produced significantly greater percentage weight loss than the UPF diet.The primary outcome directly supports this with a significant within-participant difference and effect size with CI.Evidence: Δ%WC −1.01 (95% CI −1.87 to −0.14), P = 0.024; Cohen's d −0.48 (95% CI −0.91 to −0.06).
with significantly greater %WC on MPF (Δ%WC, −1.01 (95% CI, −1.87, −0.14), P = 0.024; Cohen's d , −0.48 (95% CI, −0.91, −0.06))
Abstractreviewer’s wording - supportedReviewer 1The greater weight loss on the MPF diet was driven by greater reductions in fat mass and total body water mass.Table 2 shows significantly greater reductions on MPF for fat mass and total body water mass, with no difference in fat-free mass.Evidence: Fat mass −0.98 kg (s.e. 0.32, P=0.004); total body water mass −0.51 kg (s.e. 0.15, P=0.002); fat-free mass difference 0.00 (P=0.993).
“We observed that the greater weight loss on the MPF diet was through greater reductions in fat mass and total body water mass, with no significant differences in fat-free mass change between diets.”
DiscussionFind in source - supportedReviewer 1Following UK dietary guidance with a UPF diet resulted in weight loss (not weight gain).The UPF diet produced significant weight loss within the trial, directly supporting this claim.Evidence: UPF %WC −1.05 (95% CI −1.98 to −0.13), i.e. significant weight loss from baseline.
“In contrast with our hypothesis given the body of observational evidence linking UPF with weight gain , the UPF diet following UK dietary guidance resulted in weight loss.”
DiscussionFind in source - supportedReviewer 2Greater weight loss on MPF than UPF diet over 8 weeks.The primary outcome analysis shows a statistically significant difference in %WC favoring MPF (Δ%WC -1.01%, 95% CI -1.87 to -0.14, P=0.024), supporting this claim.Evidence: Primary outcome: Δ%WC = -1.01% (95% CI -1.87, -0.14, P=0.024).
“Within-participant differences in %WC were significantly greater on the MPF versus UPF diet (Δ%WC, −1.01% (s.e., 0.43; 95% CI, −1.87, −0.14; P = 0.024).”
ResultsFind in source - supportedReviewer 2Minimally processed diets lead to weight loss when following UK dietary guidelines.The MPF diet resulted in significant weight loss from baseline (%WC -2.06%, 95% CI -2.99 to -1.13), supporting this claim.Evidence: MPF %WC: -2.06% (95% CI -2.99, -1.13).
In the ITT analysis, %WC at 8 weeks was significantly lower on both diets (MPF, −2.06% ((95% confidence interval (CI), −2.99, −1.13); UPF, −1.05% (95% CI, −1.98, −0.13)).
Resultsreviewer’s wording - supportedReviewer 2Dietary guidance on food processing is needed in addition to existing recommendations.The finding of greater weight loss on MPF despite both diets meeting UK guidelines supports the need for additional guidance on food processing, as stated in the conclusions.Evidence: Primary outcome difference and discussion.
“Findings indicate greater weight loss on MPF than UPF diets and needing dietary guidance on food processing in addition to existing recommendations.”
DiscussionFind in source - supportedReviewer 2Greater fat mass loss on MPF than UPF diet.The secondary outcome shows a significantly greater reduction in fat mass on MPF (-0.98 kg, P=0.004).Evidence: Table 2: Fat mass difference -0.98 kg (95% CI -1.62, -0.33, P=0.004).
Reductions in fat mass (−0.98 kg (s.e., 0.32); P = 0.004)... were significantly greater on the MPF compared with UPF diet.
Table 2reviewer’s wording - supportedReviewer 3MPF diet leads to significantly greater weight loss than UPF diet when following UK dietary guidelines.The primary outcome analysis shows a statistically significant difference in percent weight change between diets, with MPF resulting in greater loss.Evidence: Primary outcome: Δ%WC = -1.01% (95% CI -1.87, -0.14; P = 0.024).
“Within-participant differences in %WC were significantly greater on the MPF versus UPF diet (Δ%WC, −1.01% (s.e., 0.43; 95% CI, −1.87, −0.14; P = 0.024).”
ResultsFind in source - supportedReviewer 3MPF diet leads to greater reductions in fat mass, body fat percentage, visceral fat, and total body water mass compared to UPF diet.Secondary outcomes show statistically significant differences in these body composition measures favoring MPF.Evidence: Table 2: Fat mass change -0.98 kg (P=0.004), body fat percentage -0.76% (P=0.010), visceral fat rating -0.41 (P=0.008), total body water mass -0.51 kg (P=0.002).
“Reductions in fat mass (−0.98 kg (s.e., 0.32); P = 0.004), body fat percentage (−0.76% (s.e., 0.28); P = 0.010), visceral fat rating (−0.41 (s.e., 0.15); P = 0.008) and total body water mass (−0.51 kg (s.e., 0.15); P = 0.002) were significantly greater on the MPF compared with UPF diet.”
ResultsFind in source
Data authenticity concerns
1 finding · worst lowAn adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.
- Methods and results do not matchAssessed
2 integrity concerns flagged (0 high).
- lowmethod result mismatchThe same treatment-by-period interaction is reported with different precision in Results (P < 0.05) and Methods (P < 0.001); both indicate significance, but the inconsistency is a reporting gap.
A significant diet order effect was detected ( P interaction < 0.05 ...) ... This interaction was significant ( P < 0.001)
Statistical analysisreviewer’s wording
Reporting gaps
2 findings · worst mediumRequired detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.
- Ethics/consent reporting incompleteAssessed
- Key resources under-identified (antibodies, cell lines, RRIDs)Assessed
The paper cites two prior RCTs (Hall et al., Hamano et al.) and observational evidence linking UPF to adverse health outcomes. It explains the gap: no trial has assessed UPF in the context of national dietary guidelines. It directly addresses limitations of prior work (metabolic ward, short duration) by using an 8-week free-living design with diets matched to UK Eatwell Guide recommendations.
“Strengths of UPDATE include the 8-week duration of each intervention. Diets were matched for UK national dietary guidance, ensuring results are directly relevant for UK public health food policy.”
“To date, two RCTs demonstrate unfavorable weight changes on UPF compared with MPF diets matched for presented energy and nutrients”
Randomization was block-randomized using Sealed Envelope, stratified by nightshift status, sex, and ethnicity. The unit of randomization is the individual participant. Participants were blinded to the primary outcome and diet allocation (Diet A/B); researchers were not blinded, but an independent statistician verified the primary outcome blind. A power calculation was provided (n=44 needed, 55 recruited for 20% dropout). Inclusion/exclusion criteria are detailed. Outlier handling is addressed via ITT and PP analyses and sensitivity analyses with multiple imputation.
“Participants were not informed of the processing groups of the diets.”
“Participants were not informed of the processing groups of the diets. All participant communications omitted the terms MPF or UPF, with diets being referred to as Diet A or Diet B.”
“Participants were not informed of the processing groups of the diets. All participant communications omitted the terms MPF or UPF, with diets being referred to as Diet A or Diet B.”
Sex is reported (90.9% female). Age, weight, BMI, and health status are reported in Table 1. Detailed demographics (ethnicity, occupation, education, marital status, etc.) are provided. Since both sexes are enrolled, sex_justification is not applicable. Species/strain and housing conditions are not applicable for a human study.
“Mean age was 43.2 years (s.e., 1.5), 36 (65.5%) were of white ethnicity, 50 (90.9%) were female”
“Mean weight was 89.4 kg (s.e., 1.7), and body mass index (BMI) 32.7 kg m −2 (s.e., 0.5).”
“50 (90.9%) were female”
“Table 1 Baseline demographic and clinical characteristics overall and by randomization arm”
The paper reports named ethics committee approval (Yorkshire and The Humber–Sheffield Research Ethics Committee, 22/YH/0281) and written informed consent. However, it does not explicitly state adherence to a recognized regulatory framework such as the Declaration of Helsinki or ICH-GCP. The guide requires a named framework for regulatory_compliance to be adequate; mentioning SPIRIT and CONSORT (reporting guidelines) is insufficient.
“The Yorkshire and The Humber–Sheffield Research Ethics Committee approved the trial on 22 December 2022 (22/YH/0281).”
“All participants provided written informed consent before any screening or research-associated measurement.”
“The Yorkshire and The Humber–Sheffield Research Ethics Committee approved the trial on 22 December 2022 (22/YH/0281).”
“Written informed consent was obtained before any screening or research-associated measurement.”
“The Yorkshire and The Humber–Sheffield Research Ethics Committee approved the trial on 22 December 2022 (22/YH/0281).”
“All participants provided written informed consent before any screening or research-associated measurement.”
The diets are the investigational product. The paper describes the MPF diet as 'culinary preparations of individual ingredients' and the UPF diet as sourced from 'leading UK supermarkets', but does not provide specific product names, manufacturers, or batch numbers. Software tools (R, Excel, Prism, ActiGraph) are identified with versions. Other sub-criteria (antibodies, cell lines, mycoplasma, organisms) are not applicable.
“UPF was sourced from leading UK supermarkets and were not culinary preparations, providing a diet representative of UPF available in the UK.”
“Analyses were conducted in R v.2024.04.1+748. Data were presented in tabular form using Microsoft Excel v.16.91 (24111020), figures were created using Prism 10 v.10.2.3.”
“Meals and snacks on the MPF diet were culinary preparations of individual ingredients (for example, raw meat, vegetables, oats, butter) ensuring correct Nova classification and no ambiguous decision on mixed dishes/shop-bought items.”
Mixed-effects models are named as the primary analysis. Assumptions (normality, homoscedasticity) were checked visually. Exact p-values are reported for the primary outcome (P=0.024) and many secondary outcomes. Effect sizes with 95% CIs are reported (Cohen's d, mean differences). Software is identified with versions. Individual data points are shown in Figure 2d,e. Mathematical plausibility is not applicable as the primary outcome is continuous and model-derived.
“Mixed-effects model assumptions including normality of residuals and homoscedasticity were checked visually and verified.”
“Analyses were conducted in R v.2024.04.1+748.”
“135 adults underwent screening, of whom 55 (40.1%) were eligible”
“Mixed-effects model assumptions including normality of residuals and homoscedasticity were checked visually and verified.”
“Mixed-effects model assumptions including normality of residuals and homoscedasticity were checked visually and verified.”
“Within-participant differences in %WC were significantly greater on the MPF versus UPF diet (Δ%WC, −1.01% (s.e., 0.43; 95% CI, −1.87, −0.14; P = 0.024).”
The data availability statement specifies contacting the corresponding author, with a timeline of 3 months for approval and 3 months for provision. This is a concrete route, though not a named platform. Code is available on GitHub without restriction. Repository deposit is not applicable as patient-level data cannot be deposited in a public repository due to privacy.
“Code for the analysis is publicly available and available without restriction via GitHub at https://github.com/SamuelJDicken/UPDATE”
Methods are detailed enough for replication. The trial is registered (NCT05627570). CONSORT and SPIRIT guidelines are referenced. All pre-specified outcomes are reported, with separate reporting for MRI outcomes acknowledged. Limitations are discussed in a dedicated paragraph. Conclusions are proportional to the evidence. Funding sources and conflicts of interest are explicitly stated.
“reporting was according to the Consolidated Standards of Reporting Trials (CONSORT)”
“Changes in BP and HR did not differ significantly between diets.”
“Limitations include that a potential carryover effect cannot be ruled out. However, the washout period helped minimize this. People with dietary restrictions (for example, vegan, halal, kosher) were excluded due to financial and logistical constraints, limiting generalizability.”
Registered (1 ID: ClinicalTrials.gov). Reporting guidelines cited: CONSORT, SPIRIT.
Broken references and links
None foundReferences checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.
Checked — nothing surfaced.
6 data/code links checked; 6 live.
- datahttps://clinicaltrials.gov/study/NCT05627570LIVEHTTP 200Resolves, but the content could not be matched to the paper.
- datahttps://clinicaltrials.gov/ct2/show/NCT05627570LIVEHTTP 200Resolves, but the content could not be matched to the paper.
- codeGitHubLIVEHTTP 200https://github.com/SamuelJDicken/UPDATEResolves to GitHub (code repository).
- codehttps://www.sealedenvelope.comLIVEHTTP 200Resolves, but the content could not be matched to the paper.
- codehttps://intake24.co.ukLIVEHTTP 200Resolves, but the content could not be matched to the paper.
- codehttps://www.project-redcap.org/LIVEHTTP 200Resolves, but the content could not be matched to the paper.
Copyediting
5 minorWording, consistency and formatting errors that need correcting before submission.
No major wording or formatting errors. 5 minor suggestions below.
5 copyedit issues flagged: mostly consistency, typo, clarity.
- MINORconsistencyResults, Participant disposition“135 adults underwent screening, of whom 55 (40.1%) were eligible”→ Change to 40.7% (55/135 = 40.7%)Arithmetic discrepancy.
- MINORtypoTable 3 footnote“Gastrointestinal adverse events: two vomiting/nausea, one diarrhea, one dyspepsia/gastresophageal reflux on the MPF diet ...”→ Change 'gastresophageal' to 'gastroesophageal'Typo in footnote.
- MINORclarityAbstract“Findings indicate greater weight loss on MPF than UPF diets and needing dietary guidance on food processing in addition to existing recommendations.”→ Rephrase, e.g. '...diets and suggest a need for dietary guidance on food processing...'Awkward grammar ('needing dietary guidance').
- MINORconsistencyResults vs Methods“A significant diet order effect was detected ( P interaction < 0.05 ...) ... This interaction was significant ( P < 0.001)”→ Use one consistent threshold/precision for the same interaction termSame interaction reported with different precision (<0.05 and <0.001).
- MINORgrammarAbstract“Findings indicate greater weight loss on MPF than UPF diets and needing dietary guidance on food processing in addition to existing recommendations.”→ Rephrase to 'Findings indicate greater weight loss on MPF than UPF diets, suggesting the need for dietary guidance on food processing in addition to existing recommendations.'Awkward phrasing: 'and needing' is not standard.
As a post-publication audit, the published work is methodologically robust and its core findings (weight loss on MPF vs UPF) are credible; an informed reader should weigh the minor reporting gaps above. The most consequential item is the overstated 'cardiometabolic improvements' conclusion, which would warrant a clarificatory correction or re-framing; the arithmetic and interaction-precision inconsistencies are minor and would warrant a typographical erratum. None of the issues threaten the validity of the primary outcome.
- 1.HIGHrigorTemper the headline claim 'The MPF diet conferred greater cardiometabolic improvements than the UPF diet' in the Abstract and Discussion to reflect that only triglycerides were significantly lower on MPF, LDL-C was significantly lower on UPF, and BP, glucose, lipids and HbA1c mostly did not differ between diets.The claim_audit rated this conclusion as overstated relative to the presented evidence, and over-claiming is the most common reviewer objection in a post-publication robustness assessment.
- 2.HIGHethicsAdd an explicit regulatory-compliance statement (e.g. 'The trial was conducted in accordance with the Declaration of Helsinki') in the Methods/Ethics section.All three reviewers flagged the absence of a named compliance framework as the sole reason for the ethical_approvals warn; a one-sentence addition would resolve it.
- 3.MEDIUMcopyeditCorrect the eligibility percentage in Results, Participant disposition from 40.1% to 40.7% (55/135).This is a demonstrable arithmetic error independently flagged by a reviewer, the copyedit pass, and the integrity check.
- 4.MEDIUMreportingUse one consistent significance value for the treatment-by-period interaction: reconcile 'P interaction < 0.05' (Results) with 'P < 0.001' (Methods).The same interaction term is reported with different precision across sections, which is an internal-consistency gap flagged by a reviewer, the copyedit pass, and the integrity check.
- 5.MEDIUMcopyeditFix the typo 'gastresophageal' to 'gastroesophageal' in the Table 3 footnote.Copyedit-flagged typo in the adverse-events footnote.
- 6.MEDIUMcopyeditRephrase the Abstract sentence 'Findings indicate greater weight loss on MPF than UPF diets and needing dietary guidance on food processing...' to 'Findings indicate greater weight loss on MPF than UPF diets, suggesting the need for dietary guidance on food processing...'.The current phrasing ('and needing dietary guidance') is grammatically awkward and was flagged by the copyedit pass.
- 7.MEDIUMreportingClarify whether outcome assessors beyond the primary outcome (e.g. those measuring blood pressure, body composition, blood samples) were blinded to diet allocation.Reviewer 2 noted that blinding is described for participants and the independent statistician, but not for other outcome assessors; this is a transparency gap relevant to bias assessment.
- 8.MEDIUMreportingProvide more specific identification of UPF items (representative brands, manufacturers, or a product list in supplementary materials) in the Methods/Intervention section.Reviewer 2 flagged the UPF source as vague ('leading UK supermarkets'); more detail would strengthen reproducibility of the intervention.
- 9.LOWdata codeAdd a permanent identifier (e.g. a Zenodo DOI) for the code repository to ensure long-term accessibility.Reviewer 3 suggested this; a DOI guards against link rot and improves the reproducibility record.
- 10.LOWreportingAdd a brief justification in the Discussion for the high proportion of female participants (90.9%).Reviewer 3 noted this could help address potential sex-imbalance concerns about generalizability.
- 11.LOWdata codeConsider depositing summary-level (aggregate) data in a repository such as Figshare or Dryad, or formally naming a data-access committee (e.g. UCL Data Access Committee) in the Data Availability statement.Reviewer 2 suggested this would move the data availability statement from a managed-access route to a more formal, discoverable arrangement.
- 12.LOWstatisticsReport the exact t-statistic (or test statistic with df) for the primary outcome to allow full reproducibility of the p-value.Reviewer 2 suggested this; the primary outcome is currently reported with p-value and CI but without the underlying test statistic.
The star rating is the report’s one-glance summary. Every paper starts at 5★ and loses stars for the concrete problems the review finds — so a rating is never a vague average, it’s a running total you can read line by line under “How this rating was calculated.”
- Reporting — 8 dimensionseach dimension that fully fails−½★
- each dimension partially met−¼★
- Statistics · Integrity · Claimseach serious problem−1★
- each medium problem−½★
- Citationseach retracted or unverifiable reference−¼★
- Copyeditonly when the manuscript needs a full edit−½★
The rating never drops below 1★, and a demonstrable critical failure (an impossible statistic, a proven ethics violation) caps it at 1★ on its own — so the stars can never look healthy when the verdict is CRITICAL.
The rating draws on a panel of agents. Three independent Kaimen Rigor reviewers grade the eight dimensions below across several independent passes (the shown verdict is their majority vote — steadier than any single run), isolate the paper’s major claims and check its own evidence backs them, and flag integrity concerns. Alongside them, a citation agent resolves every reference against Crossref, OpenAlex, and Retraction Watch; a statistics agent recomputes reported tests; and rule-based checks verify that declared data/code links actually resolve. Full text is required — an abstract-only submission is not analyzed.
Graded against NIH, MDAR, ARRIVE 2.0, CONSORT, EQUATOR, and RRID guidelines. A dimension that doesn’t apply to the study type is skipped, never penalized.
This Kaimen Rigor review is model-assisted and is not a substitute for formal expert review. It complements human evaluation by surfacing potential methodological concerns — verify each finding against the source.