Faculty of Regional Environment Science, Tokyo University of Agriculture, 1-1-1 Sakuragaoka, Setagaya-ku, Tokyo 156-8502, Japan.
Division of Biostatistics and Clinical Epidemiology, School of Medicine, University of Toyama, 2630 Sugiya, Toyama 930-0194, Japan.
Nutrients. 2021 Dec 25;14(1):81. doi: 10.3390/nu14010081.
A new type of foods with a health claims notification system, the Foods with Function Claims (FFC), was introduced in Japan in April 2015. This cross-sectional study sought to clarify compliance of clinical trial protocols reported as the scientific basis of efficacy in the FFC system.
All articles based on clinical trials published on the Consumer Affairs Agency website from 1 July 2018 to 30 June 2021 were reviewed. Items assessed included first author characteristics (for-profit or academia), journal name, year published, journal impact factor in 2020, article language, name of clinical trial registration (CTR), and seven compliance items (Title: T, Participant: P, Intervention: I, Comparison: C, Outcome: O, Study design: S, and Institutional Review Board, IRB). Among studies that conducted CTR, consistency with these seven compliance items was evaluated.
Out of 136 studies that met all inclusion criteria, 103 (76%) performed CTR, and CTR was either not performed or not specified for 33 (24%). Compliance between the protocol and the text was high (≥96%) for items P and S, but considerably lower for items T, I, C, O, and IRB (52%, 15%, 13%, 69%, and 27%, respectively). Furthermore, 43% of protocols did not include functional ingredients or food names in items T or I. The total score was 3.7 ± 1.1 pts (out of 7).
Some CTs had no protocol registration, and even registered protocols were suboptimal in transparency. In addition to selective reporting, a new problem identified was that the content of the intervention (test food) was intentionally concealed.
2015 年 4 月，日本推出了一种带有健康声称通知系统的新型食品，即功能性声称食品（FFC）。本横断面研究旨在阐明作为 FFC 系统功效科学依据报告的临床试验方案的依从性。
对 2018 年 7 月 1 日至 2021 年 6 月 30 日期间在消费者厅网站上发表的所有基于临床试验的文章进行了审查。评估的项目包括第一作者特征（营利性或学术性）、期刊名称、发表年份、2020 年期刊影响因子、文章语言、临床试验注册名称（CTR），以及 7 项依从性项目（标题：T、参与者：P、干预措施：I、比较：C、结果：O、研究设计：S、机构审查委员会、IRB）。对于进行 CTR 的研究，评估了其与这 7 项依从性项目的一致性。
在符合所有纳入标准的 136 项研究中，有 103 项（76%）进行了 CTR，33 项（24%）未进行或未指定 CTR。方案与文本之间的依从性在 P 和 S 项目中较高（≥96%），但在 T、I、C、O 和 IRB 项目中较低（分别为 52%、15%、13%、69%和 27%）。此外，43%的方案在 T 或 I 项目中没有包括功能成分或食品名称。总分为 3.7±1.1 分（满分 7 分）。
一些 CT 没有方案注册，即使注册的方案在透明度方面也不理想。除了选择性报告外，还发现了一个新问题，即干预措施（试验食品）的内容被故意隐瞒。
