A randomized-controlled clinical trial investigating the effect of omega-3 fatty acids and vitamin E co-supplementation on markers of insulin metabolism and lipid profiles in gestational diabetes
Assessed by RV012 · Lecturer (Teaching & Research)
Assessed on 30 Oct 2025
OverallReviewer's overall integrity assessment, derived from all research questions Serious concerns
DOI 10.1016/j.jacl.2015.12.017 (opens in new tab)
Resource ripekg:research-integrity-assessment/RIPEA233158DEF9C3F087
5 Research Questions · 52 Evidence Items
Q1.1 — Does the study have an associated retraction?
Rationale: Confirmed that there was no retraction on journal page
Supporting Evidence (1)
Retraction NoticeSource: Retraction Watch database
Effects of omega-3 fatty acid supplementation on insulin metabolism and lipid profiles in gestational diabetes: Randomized, double-blind, placebo-controlled trial
10.1016/j.clnu.2025.08.026 (opens in new tab)RetractionWatch ID:Record identifier in the Retraction Watch database 67324
Rationale: Concerns/Issues About Data;Investigation by Journal/Publisher;Investigation by Third Party;Objections by Author(s);Unreliable Results and/or Conclusions
About Authors: Zatollah Asemi, Mehri Jamilian, Mansooreh Samimi, Ahmad Esmaillzadeh
Q1.2 — Does the study have an associated expression of concern or other relevant post-publication notice?
Rationale: While this paper has not been retracted the authors have published dubious publications, and the methods they adopted here can be misleading. As data were not shared it is not possible to rerun the analyses using different approaches. If I was working on a review, I would still include the paper if it met all inclusion criteria, but this information here would influence my critical appraisal, and I would need to acknowledge data limitations.
Supporting Evidence (4)
PubPeer ThreadSource: PubPeer.com — post-publication peer review comments
https://pubpeer.com/publications/653EF82D99E63E11A490F9BB95D7C9 (opens in new tab)PubPeer CommentSource: PubPeer.com — a platform for post-publication peer review
There are many concerns about the integrity of 172 publications by this research group, including this one. Some of the concerns are published 1. Anaesthesia 2020;75:1683–92, see Supplementary data. This paper is A77 2. Account Res 2020;28:149-61. 3. J Clin Epidemiol 2021;131:22-29. Journals and publishers were notified of these concerns in July 2019. 23 publications have an expression of concern. To our knowledge there has been no public response about any of the concerns. We think these publications are unreliable
Thread: https://pubpeer.com/publications/653EF82D99E63E11A490F9BB95D7C9 (opens in new tab)
PubPeer CommentSource: PubPeer.com — a platform for post-publication peer review
[Image: table or graph with SE values for two groups] The two groups have identical SE values across all parameters. I understand that the means reflect the difference between data taken before and after the intervention period.
Thread: https://pubpeer.com/publications/653EF82D99E63E11A490F9BB95D7C9 (opens in new tab)
PubPeer CommentSource: PubPeer.com — a platform for post-publication peer review
[Image: table or graph comparing SE values for FPG and HDL across groups and studies] In all 3 studies, the SE values for “adjusted change” of FPG (mg/dL) are 1.7 for both control and treated groups. Similarly, the SE values for HDL adjusted change are 1.3 in all 6 groups (across 3 studies). In each of the 3 studies, control and treated groups have different means, but identical SE values across all measures. (expression of concern)
Thread: https://pubpeer.com/publications/653EF82D99E63E11A490F9BB95D7C9 (opens in new tab)
Q1.3 — Do other studies by the research team highlight causes for concern?
Rationale: The first, second and last authors have quite a few retracted publications and many expressions of concern. Initially I had said I would include this paper if I was doing a review on the topic and it met inclusion criteria, but now I am not so sure. The challenge is: where do we draw the line? I suppose passing the "AI-Inspect test may in the future be used as part of the inclusion criteria - academic judgement will have to prevail nonetheless.
Supporting Evidence (45)
Retraction NoticeSource: Retraction Watch database
The Effect of Zinc Supplementation on Expressed Levels of Peroxisome Proliferator-Activated Receptor Gamma and Glucose Transporter Type 1 Genes in Newborns of Women with Gestational Diabetes Mellitus
10.1007/s12011-016-0788-y (opens in new tab)RetractionWatch ID:Record identifier in the Retraction Watch database 28454
Rationale: Concerns/Issues About Data;Investigation by Company/Institution;Updated to Retraction
About Authors: Mehri Jamilian, Mansooreh Samimi, Esmat Aghadavod
Retraction NoticeSource: Retraction Watch database
Effects of Selenium Supplementation on Gene Expression Levels of Inflammatory Cytokines and Vascular Endothelial Growth Factor in Patients with Gestational Diabetes
10.1007/s12011-017-1045-8 (opens in new tab)RetractionWatch ID:Record identifier in the Retraction Watch database 28465
Rationale: Concerns/Issues About Data;Investigation by Company/Institution
About Authors: Mehri Jamilian, Mansooreh Samimi, Esmat Aghadavod, Faraneh Afshar Ebrahimi
Retraction NoticeSource: Retraction Watch database
The Effect of Zinc Supplementation on Expressed Levels of Peroxisome Proliferator-Activated Receptor Gamma and Glucose Transporter Type 1 Genes in Newborns of Women with Gestational Diabetes Mellitus
10.1007/s12011-022-03501-2 (opens in new tab)RetractionWatch ID:Record identifier in the Retraction Watch database 40895
Rationale: Concerns/Issues About Data;Concerns/Issues About Image;Concerns/Issues about Referencing/Attributions;Duplication of/in Article;Investigation by Company/Institution;Unreliable Results and/or Conclusions;Upgrade/Update of Prior Notice(s)
About Authors: Mehri Jamilian, Mansooreh Samimi, Esmat Aghadavod
Q2.2 — Are there concerns relating to the timing or absence of study registration?
Rationale: Full protocol was not available on the link provided. One month delay in registration is concerning but perhaps this was due to delays from the website? In theory I would only be slightly concerned, but when you see that the study finished in July it becomes a bigger issue. It is also concerning that the trial page was refreshed in 2019 and no additional data /progress was reported (even though the paper was published in 2016. Protocol stated that the first enrolment was on the 31st May 2015. Paper reports that 60 patients were recruited and intervention took 6 weeks, and the trial was conducted from May to July 2015 (note the start on the 31st May). Therefore, in about 8-9 weeks they recruited all patients and did the 6-week follow up, did all the analysis and wrote the whole paper in two months (the paper was submitted for publication on the 13th October). These are very tight timelines.
Supporting Evidence (2)
Clinical Trial RegistrationSource: Clinical trial registry (e.g. ClinicalTrials.gov, ISRCTN)
Registration ID: IRCT201506085623N43
Registry: IRCT
Registry Link: https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT201506085623N43 (opens in new tab)
Registration Date: 23 Jun 2015
Prospective:Whether the trial was registered before participant recruitment began No
Assessment Rationale:How INSPECT-AI determined the prospective registration status by comparing dates Comparison performed at month level. Registration: 2015-06, LLM Recruitment Start: 2015-05. Deemed retrospective at month level.
Study Design EvidenceDates and timelines extracted by INSPECT-AI from the publication text
Recruitment Start: 05-2015
Recruitment Start Rationale:INSPECT-AI's reasoning for how it identified the recruitment start date Methods: 'This study was a randomized...trial that was conducted in Kashan, Iran, during May 2015 to July 2015...' Used start of conducted range as recruitment_start per rule 5; no specific FPI elsewhere.
Recruitment End: N/A
Recruitment End Rationale:INSPECT-AI's reasoning for how it identified the recruitment end date No explicit end-of-recruitment date after full search.
Study End: 07-2015
Study End Rationale:INSPECT-AI's reasoning for how it identified the study end date Methods: 'This study was a randomized...trial that was conducted in Kashan, Iran, during May 2015 to July 2015...' Used end of conducted range as study_end_date per rule 5; no specific completion date.
Overall — What is the overall integrity assessment of the study?
Rationale: After checking all tabs, I have changed my mind and would rate this as serious concerns instead of some concerns.