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Compliance of Clinical Trial Protocols for Foods with Function Claims (FFC) in Japan: Consistency between Clinical Trial Registrations and Published Reports

1
Faculty of Regional Environment Science, Tokyo University of Agriculture, 1-1-1 Sakuragaoka, Setagaya-ku, Tokyo 156-8502, Japan
2
Division of Biostatistics and Clinical Epidemiology, School of Medicine, University of Toyama, 2630 Sugiya, Toyama 930-0194, Japan
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Physical Education and Medicine Research Center Unnan, 328 Uji, Unnan City 699-1105, Japan
4
Facult of Health Sciences, Tokyo Ariake Medical and Health Sciences University, 2-9-1 Ariake, Kouto-ku, Tokyo 135-0063, Japan
*
Author to whom correspondence should be addressed.
Nutrients 2022, 14(1), 81; https://doi.org/10.3390/nu14010081
Received: 25 November 2021 / Revised: 21 December 2021 / Accepted: 23 December 2021 / Published: 25 December 2021
(This article belongs to the Section Phytochemicals and Human Health)
Background: 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. Methods: 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. Results: 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). Conclusions: 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. View Full-Text
Keywords: clinical trial registration; protocol; compliance; foods; randomized controlled trial clinical trial registration; protocol; compliance; foods; randomized controlled trial
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MDPI and ACS Style

Kamioka, H.; Origasa, H.; Kitayuguchi, J.; Tsutani, K. Compliance of Clinical Trial Protocols for Foods with Function Claims (FFC) in Japan: Consistency between Clinical Trial Registrations and Published Reports. Nutrients 2022, 14, 81. https://doi.org/10.3390/nu14010081

AMA Style

Kamioka H, Origasa H, Kitayuguchi J, Tsutani K. Compliance of Clinical Trial Protocols for Foods with Function Claims (FFC) in Japan: Consistency between Clinical Trial Registrations and Published Reports. Nutrients. 2022; 14(1):81. https://doi.org/10.3390/nu14010081

Chicago/Turabian Style

Kamioka, Hiroharu, Hideki Origasa, Jun Kitayuguchi, and Kiichiro Tsutani. 2022. "Compliance of Clinical Trial Protocols for Foods with Function Claims (FFC) in Japan: Consistency between Clinical Trial Registrations and Published Reports" Nutrients 14, no. 1: 81. https://doi.org/10.3390/nu14010081

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