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

• Published in: Nutrients Vol. 14; no. 1; p. 81
• Main Authors: Kamioka, Hiroharu, Origasa, Hideki, Kitayuguchi, Jun, Tsutani, Kiichiro
• Format: Journal Article
• Language: English
• Published: Switzerland MDPI AG 25-12-2021; MDPI
• Subjects: Biomedical Research - methods; Biomedical Research - standards; Clinical Trial Protocols as Topic; clinical trial registration; Clinical trials; Compliance; Consumers; Food; foods; Functional Food; Humans; Impact factors; Japan; protocol; randomized controlled trial; Registration; Review; Websites; Japan; protocol; foods; clinical trial registration; compliance; randomized controlled trial
• ISSN: 2072-6643; 2072-6643
• 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.