Skip to content

Research quality of clinical trials reported for Foods with Functional Claims in Japan: evaluation based on a revised tool to assess risk of bias in randomized trials

Research quality of clinical trials reported for Foods with Functional Claims in Japan: evaluation based on a revised tool to assess risk of bias in randomized trials (RoB 2) - Research quality of clinical trials reported for Foods with Functional Claims in Japan

Status
Active, not recruiting
Phases
Unknown
Study type
Unknown
Source
JPRN
Registry ID
JPRN-UMIN000054051
Enrollment
Unknown
Registered
2024-04-04
Start date
2024-04-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nothing

Interventions

None listed

Sponsors

Tokyo University of Agriculture
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All submitted papers based on CTs published on the CAA website during the period from January 1, 2024 to June 30, 2024* are eligible. Papers based on systematic reviews and observational studies will be excluded. If there is overlap, such as multiple notifications using the same paper as proof of functionality, only the first paper will be accepted. *The health hazards detected in March 2024 that were caused by supplements manufactured and sold by KOBAYASHI Pharmaceutical Co., Ltd. have become a major social issue. As a result, the study period may be extended if the number of samples is small due to delays in notifications to the CAA. The extension has been changed to January 1, 2023 to June 30, 2024. The reason for this is that, as mentioned above*, the number of reports was small and the number of evaluation papers was insufficient.

Exclusion criteria

Exclusion criteria: In this study, intervention studies (single-arm) without a comparison group will be excluded as a research design.

Design outcomes

Primary

MeasureTime frame
Overall RoB 2 score

Secondary

MeasureTime frame
Each domain score

Countries

Japan

Contacts

Public ContactHiroharu Kamioka

Tokyo University of Agriculture Department of Regional Environment Science

h1kamiok@nodai.ac.jp0354772587

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026