UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054051 |
|---|---|
| Receipt number | R000061712 |
| Scientific Title | 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) |
| Date of disclosure of the study information | 2024/04/04 |
| Last modified on | 2024/04/03 15:52:51 |
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Basic information
Public title
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
Acronym
Research quality of clinical trials reported for Foods with Functional Claims in Japan
Scientific Title
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)
Scientific Title:Acronym
Research quality of clinical trials reported for Foods with Functional Claims in Japan
Region
| Japan |
Condition
Condition
Nothing
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the risk of bias using "A revised tool to assess risk of bias in randomized trials (RoB 2)"for notifications based on recent clinical trials (CTs) published on the Japanese Consumer Affairs Agency (CAA) website, and to clarify the characteristics associated with them.
Basic objectives2
Others
Basic objectives -Others
What is the relationship between the following four items: the quality of research methodology and the affiliations of the author (for-profit researcher, academia researcher), the year in which the paper was published, English versus Japanese language, and the journal impact factor. We will also look at issues that could be improved for these items.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall RoB 2 score
Key secondary outcomes
Each domain score
Base
Study type
Others,meta-analysis etc
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
| 84 | years-old | >= |
Gender
Male and Female
Key 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.
Key exclusion criteria
In this study, intervention studies (single-arm) without a comparison group will be excluded as a research design.
Target sample size
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 Regional Environment Science
Zip code
156-8502
Address
Sakuragaoka 1-1-1, Setagaya-ku, Tokyo
TEL
0354772587
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 Regional Environment Science
Zip code
156-8502
Address
Sakuragaoka 1-1-1, Setagaya-ku, Tokyo
TEL
0354772587
Homepage URL
h1kamiok@nodai.ac.jp
Sponsor or person
Institute
Tokyo University of Agriculture
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (C) from the 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, Tokyo University of Agriculture
Address
Sakuragaoka 1-1-1, Setagaya-ku, Tokyo
Tel
0354772532
h1kamiok@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
| 2024 | Year | 04 | Month | 04 | Day |
Related information
URL releasing protocol
https://1drv.ms/b/s!AoQmpnIHE3YUhMo58Yre7E_YSnXQzw?e=VdKCMF
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 04 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Organization (Researchers)
Hiroharu Kamioka 1,*
Kiichiro Tsutani 2
Hideki Origasa 3
Jun Kitayuguchi 4
1 Faculty of Regional Environment Science, Tokyo University of Agriculture, 1-1-1 Sakuragaoka,
Setagaya-ku, Tokyo 156-8502, Japan
2 Physical Education and Medicine Research Center Unnan, 328 Uji, Unnan City, Shimane 699-1105, Japan
3 Institute of Statistical Mathematic, 10-3 Midori-cho, Tachikawa City, Tokyo 190-8562, Japan
4 The Institute of Seizon and Life Sciences, 4-5-1 Ginza, Chuo-ku, Tokyo 104-0061, Japan
* Correspondence: h1kamiok@nodai.ac.jp
Research collaborators
We will mainly utilize Ms. Michiko Ishida for paper work and Ms. Mari Makishi and Ms. Satoko Sayama for collecting related papers.
Author Contributions
HK conceived and designed the study and will make a brief summary list of included studies and data extraction, and evaluating the quality of articles. JK will carry out statistical analysis. HO will confirm the appropriateness of the analysis method. HK will describe the draft article. KT and HO will be the guarantors.
Conflicts of Interest
HK supervised systematic reviews for five corporations (FANCL CORPORATION, Morishita Jintan Co., Ltd., KAGOME Co., Ltd., MARUZEN PHARMACEUTICAL CO., LTD., SUNTORY WELLNESS LIMITED, Suntory Beverage & Food Limited, and FUJIFILM Corporation) and was compensated for that work. The other authors have no conflicts to declare.
Management information
Registered date
| 2024 | Year | 04 | Month | 03 | Day |
Last modified on
| 2024 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061712
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| Research case data specifications | |
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| Research case data | |
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