UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046267 |
|---|---|
| Receipt number | R000052795 |
| Scientific Title | Risk of bias in clinical trials reported for Foods with Functional Claims in Japan: a cross-sectional study on research quality |
| Date of disclosure of the study information | 2021/12/03 |
| Last modified on | 2022/10/25 14:14:31 |
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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
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
h1kamiok@nodai.ac.jp
Sponsor or person
Institute
Tokyo University of Agriculture
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052795
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
