UMIN-CTR Clinical Trial

Basic information
Public title	Risk of bias in clinical trials reported for Foods with Functional Claims
Acronym	Risk of bias in clinical trials reported for Foods with Functional Claims
Scientific Title	Risk of bias in clinical trials reported for Foods with Functional Claims in Japan: a cross-sectional study on research quality
Scientific Title:Acronym	Risk of bias in clinical trials reported for Foods with Functional Claims
Region	Japan

Condition
Condition	Nothing
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to clarify risk of bias (RoB) and related factors of clinical trials (CTs) reported as the scientific basis of efficacy in the Foods with Function Claims (FFC) system.
Basic objectives2	Others
Basic objectives -Others	Nothing
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	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.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key 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.
Key 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.
Target sample size	103

Research contact person
Name of lead principal investigator	1st name Hiroharu Middle name Last name Kamioka
Organization	Tokyo University of Agriculture
Division name	Department of Ecological Symbiotic Science, Graduate School of Agriculture
Zip code	156-8502
Address	Sakuragaoka 1-1-1, Setagaya-ku, Tokyo
TEL	+81354772587
Email	h1kamiok@nodai.ac.jp

Public contact
Name of contact person	1st name Hiroharu Middle name Last name Kamioka
Organization	Tokyo University of Agriculture
Division name	Department of Ecological Symbiotic Science
Zip code	156-8502
Address	Sakuragaoka 1-1-1, Setagaya-ku, Tokyo
TEL	+81354772587
Homepage URL
Email	h1kamiok@nodai.ac.jp

Sponsor
Institute	Tokyo University of Agriculture
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB of Tokyo University of Tokyo
Address	Sakuragaoka 1-1-1, Setagaya-ku, Tokyo
Tel	0354772562
Email	t3tanaka@nodai.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 12 Month 03 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	103
Results	The risk of bias (RoB) score was 5.7 pts. There was a remarkable lack of execution and/or description of the intention-to-treatment analysis (81.6%), compliance (68.0%), and multiple outcome tests (67.0%). There was also no significant difference (p = 0.247) in RoB score between English (5.5 pts) and Japanese (6.0 pts) language publications, and no significant difference (p = 0.740) between for-profit (5.7 pts) and academia (6.0 pts) in authors' organization.
Results date posted	2022 Year 10 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2021 Year 12 Month 02 Day
Date of IRB	2022 Year 12 Month 05 Day
Anticipated trial start date	2021 Year 12 Month 06 Day
Last follow-up date	2022 Year 01 Month 31 Day
Date of closure to data entry	2022 Year 02 Month 06 Day
Date trial data considered complete	2022 Year 02 Month 10 Day
Date analysis concluded	2022 Year 02 Month 28 Day

Other
Other related information	All the protocols in the input settings can be viewed from this link: https://drive.google.com/file/d/1c1M02bZrztnA7AR8myjgxN3rWtuEtzmV/view?usp=sharing This study was published in the following journal. Kamioka et al. Risk of bias in clinical trials reported for Foods with Functional Claims in Japan: a cross-sectional study on research quality. J Clinical Trials 2022; 12: 1000503

Management information
Registered date	2021 Year 12 Month 03 Day
Last modified on	2022 Year 10 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052795