Flávia Moraes Silva , Amanda Rodrigues Amorim Adegboye , Celeste Naude , Cintia Curioni , Fabio S Gomes , Gary S Collins , Gilberto Kac , Jennifer Anne de Beyer , Jonathan Cook , Leila Cheikh Ismail , Matthew J Page , Neha Khandpur , Sallie Lamb , Sally Hopewell , Shaima Saleh , Shona Kirtley , Simone Bernardes , Solange Durão , Colby J Vorland , Michael Maia Schlussel
{"title":"Describing the landscape of nutrition- and diet-related randomized controlled trials: metaresearch study of protocols published between 2012 and 2022","authors":"Flávia Moraes Silva , Amanda Rodrigues Amorim Adegboye , Celeste Naude , Cintia Curioni , Fabio S Gomes , Gary S Collins , Gilberto Kac , Jennifer Anne de Beyer , Jonathan Cook , Leila Cheikh Ismail , Matthew J Page , Neha Khandpur , Sallie Lamb , Sally Hopewell , Shaima Saleh , Shona Kirtley , Simone Bernardes , Solange Durão , Colby J Vorland , Michael Maia Schlussel","doi":"10.1016/j.ajcnut.2025.01.016","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Publishing protocols promotes transparency and reproducibility. The scope and methods of protocols for nutrition- and diet-related randomized controlled trials (RCTs) have not been investigated yet.</div></div><div><h3>Objectives</h3><div>This study aims to map the landscape of nutrition- and diet-related interventions research.</div></div><div><h3>Methods</h3><div>We conducted a metaresearch of nutrition-and diet-related RCT protocols published between January 2012 and March 2022, in any language, targeting human participants, evaluating nutrition interventions isolated or combined. A systematic search of the literature was conducted in 6 online databases. Bibliometric information, study characteristics, and research transparency practices data were collected from the included publications. The instructions for authors of journals with publications in our sample were checked for endorsement of reporting guidelines. Mentions to reporting guidelines in the included protocols were also checked.</div></div><div><h3>Results</h3><div>Among the 62,319 records retrieved, 1068 were eligible. The number of published protocols increased annually, with a mean of 103 (range: 32–163) publications/y. Protocols were published in 148 journals, 50 of them (33.8%) endorsed Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT), 111 (75.3%) Consolidated Standards of Reporting Trials (CONSORT), and 4 (2.7%) Template for Intervention Description and Replication (TIDieR), whereas 343 (32.1%) protocols mentioned SPIRIT, 297 (27.8%) CONSORT, and 20 (1.9%) TIDieR. Most protocols reported the <span>RCT</span> registration number (<em>n</em> = 1006; 94.2%) and included statements about conflicts of interest (<em>n</em> = 952; 89.1%) and funding (<em>n</em> = 994; 93.2%). About two-thirds of protocols focused on adults or elderly participants (<em>n</em> = 677; 63.4%). Most protocols described 1 isolated nutrition- or diet-related intervention (<em>n</em> = 724; 67.8%), which were most frequently “supplementation, supplements or fortification” (<em>n</em> = 405; 37.9%) or “nutrition education, counseling or coordination of care” (<em>n</em> = 354; 33.1%). The most frequent primary outcomes reported were related to clinical status (<em>n</em> = 308; 28.8%).</div></div><div><h3>Conclusions</h3><div>The number of protocols for nutrition- or diet-related RCTs published is increasing, supporting the raising awareness and the importance of promoting these publications. The support and mention of relevant reporting guidelines by journals and researchers, respectively, remain far from ideal.</div></div>","PeriodicalId":50813,"journal":{"name":"American Journal of Clinical Nutrition","volume":"121 4","pages":"Pages 882-891"},"PeriodicalIF":6.9000,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"American Journal of Clinical Nutrition","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0002916525000164","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"NUTRITION & DIETETICS","Score":null,"Total":0}
引用次数: 0
Abstract
Background
Publishing protocols promotes transparency and reproducibility. The scope and methods of protocols for nutrition- and diet-related randomized controlled trials (RCTs) have not been investigated yet.
Objectives
This study aims to map the landscape of nutrition- and diet-related interventions research.
Methods
We conducted a metaresearch of nutrition-and diet-related RCT protocols published between January 2012 and March 2022, in any language, targeting human participants, evaluating nutrition interventions isolated or combined. A systematic search of the literature was conducted in 6 online databases. Bibliometric information, study characteristics, and research transparency practices data were collected from the included publications. The instructions for authors of journals with publications in our sample were checked for endorsement of reporting guidelines. Mentions to reporting guidelines in the included protocols were also checked.
Results
Among the 62,319 records retrieved, 1068 were eligible. The number of published protocols increased annually, with a mean of 103 (range: 32–163) publications/y. Protocols were published in 148 journals, 50 of them (33.8%) endorsed Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT), 111 (75.3%) Consolidated Standards of Reporting Trials (CONSORT), and 4 (2.7%) Template for Intervention Description and Replication (TIDieR), whereas 343 (32.1%) protocols mentioned SPIRIT, 297 (27.8%) CONSORT, and 20 (1.9%) TIDieR. Most protocols reported the RCT registration number (n = 1006; 94.2%) and included statements about conflicts of interest (n = 952; 89.1%) and funding (n = 994; 93.2%). About two-thirds of protocols focused on adults or elderly participants (n = 677; 63.4%). Most protocols described 1 isolated nutrition- or diet-related intervention (n = 724; 67.8%), which were most frequently “supplementation, supplements or fortification” (n = 405; 37.9%) or “nutrition education, counseling or coordination of care” (n = 354; 33.1%). The most frequent primary outcomes reported were related to clinical status (n = 308; 28.8%).
Conclusions
The number of protocols for nutrition- or diet-related RCTs published is increasing, supporting the raising awareness and the importance of promoting these publications. The support and mention of relevant reporting guidelines by journals and researchers, respectively, remain far from ideal.
期刊介绍：
American Journal of Clinical Nutrition is recognized as the most highly rated peer-reviewed, primary research journal in nutrition and dietetics.It focuses on publishing the latest research on various topics in nutrition, including but not limited to obesity, vitamins and minerals, nutrition and disease, and energy metabolism.
Purpose:
The purpose of AJCN is to:
Publish original research studies relevant to human and clinical nutrition.
Consider well-controlled clinical studies describing scientific mechanisms, efficacy, and safety of dietary interventions in the context of disease prevention or health benefits.
Encourage public health and epidemiologic studies relevant to human nutrition.
Promote innovative investigations of nutritional questions employing epigenetic, genomic, proteomic, and metabolomic approaches.
Include solicited editorials, book reviews, solicited or unsolicited review articles, invited controversy position papers, and letters to the Editor related to prior AJCN articles.
Peer Review Process:
All submitted material with scientific content undergoes peer review by the Editors or their designees before acceptance for publication.
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