Risk of bias in clinical trials reported for Foods with Functional Claims

Risk of bias in clinical trials reported for Foods with Functional Claims in Japan: a cross-sectional study on research quality - Risk of bias in clinical trials reported for Foods with Functional Claims

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000046267

Enrollment

103

Registered

2021-12-03

Start date

2021-12-06

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All reported articles based on CTs published on the CAA website during the three years from July 1, 2018 to June 30, 2021 will be reviewed.

Exclusion criteria

Exclusion criteria: Articles about systematic reviews and observational studies will be excluded, and articles in which clinical trial registration (CTR) was not specified will be excluded. For articles that are duplicates, such as multiple notifications using the same article, only the first article will be adopted.

Design outcomes

Primary

Measure	Time frame
We will evaluate a total of 14 items about RoB in the target articles (RoB score).These items will include the following combined elements (see the detail protocol in the additional file): 11 items described by van Tulder et al. in their revised Cochrane's criteria list, and three items we have added to the revised Cochrane's list.	—

Countries

Japan

Contacts

Public ContactHiroharu Kamioka

Tokyo University of Agriculture Department of Ecological Symbiotic Science

h1kamiok@nodai.ac.jp+81354772587

Outcome results