Silva Flávia Moraes, Amorim Adegboye Amanda Rodrigues, Naude Celeste, Curioni Cintia, Gomes Fabio S, Collins Gary S, Kac Gilberto, Anne de Beyer Jennifer, Cook Jonathan, Ismail Leila Cheikh, Page Matthew J, Khandpur Neha, Lamb Sallie, Hopewell Sally, Saleh Shaima, Kirtley Shona, Bernardes Simone, Durão Solange, Vorland Colby J, Schlussel Michael Maia
Nutrition Department and Graduate Program of Nutrition Science, Federal University of Health Science of Porto Alegre, Porto Alegre, Brazil.
Centre for Healthcare Research and School of Nursing, Midwifery and Health, Faculty of Health and Life Sciences, Coventry University, Centre for Agroecology, Water and Resilience, Coventry, United Kingdom.
Am J Clin Nutr. 2025 Apr;121(4):882-891. doi: 10.1016/j.ajcnut.2025.01.016. Epub 2025 Jan 24.
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.
This study aims to map the landscape of nutrition- and diet-related interventions research.
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.
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%).
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.
发布研究方案可提高透明度和可重复性。目前尚未对营养与饮食相关随机对照试验（RCT）方案的范围和方法进行研究。
本研究旨在描绘营养与饮食相关干预研究的概况。
我们对2012年1月至2022年3月期间以任何语言发表的、针对人类参与者、评估单独或联合营养干预措施的营养与饮食相关RCT方案进行了元研究。在6个在线数据库中进行了系统的文献检索。从纳入的出版物中收集文献计量信息、研究特征和研究透明度实践数据。检查了我们样本中有出版物的期刊的作者指南，以确定其对报告指南的认可情况。还检查了纳入方案中对报告指南的提及。
在检索到的62319条记录中，1068条符合条件。已发表方案的数量逐年增加，平均每年发表103篇（范围：32 - 163篇）。方案发表在148种期刊上，其中50种（33.8%）认可《干预性试验标准方案项目：建议》（SPIRIT），111种（75.3%）认可《报告试验的统一标准》（CONSORT），4种（2.7%）认可《干预描述与复制模板》（TIDieR），而343篇（32.1%）方案提及了SPIRIT，297篇（27.8%）提及了CONSORT，20篇（1.9%）提及了TIDieR。大多数方案报告了RCT注册号（n = 1006；94.2%），并包含了关于利益冲突（n = 952；89.1%）和资金（n = 994；93.2%）的声明。约三分之二的方案关注成年人或老年参与者（n = 677；63.4%）。大多数方案描述了1种单独的营养或饮食相关干预措施（n = 724；67.8%），其中最常见的是“补充、补充剂或强化”（n = 405；37.9%）或“营养教育、咨询或护理协调”（n = 354；33.1%）。报告的最常见主要结局与临床状况相关（n = 308；28.8%）。
营养或饮食相关RCT方案的发表数量在增加，这支持了人们对提高这些出版物的认识及其重要性的认识不断提高。期刊和研究人员对相关报告指南的支持和提及仍远不理想。
