UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062655 |
|---|---|
| Receipt number | R000071722 |
| Scientific Title | Reporting quality of clinical trials submitted for Foods with Function Claims in Japan: a pilot scoping review based on CONSORT 2025 checklists |
| Date of disclosure of the study information | 2026/08/22 |
| Last modified on | 2026/08/22 09:10:28 |
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Basic information
Public title
Reporting quality of clinical trials submitted for Foods with Function Claims in Japan: a pilot scoping review based on CONSORT 2025 checklists
Acronym
Reporting quality of clinical trials submitted for Foods with Function Claims in Japan
Scientific Title
Reporting quality of clinical trials submitted for Foods with Function Claims in Japan: a pilot scoping review based on CONSORT 2025 checklists
Scientific Title:Acronym
Reporting quality of clinical trials submitted for Foods with Function Claims in Japan
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether the 30 items in the CONSORT 2025 checklist are adequately reported in CTs submitted as scientific evidence supporting the functionality claims of FFC during the period from January to August 2026.
Basic objectives2
Others
Basic objectives -Others
Nothing.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
For the assessment of reporting quality, the presence or absence of each of the 30 items in the CONSORT 2025 checklist will be evaluated.
Key secondary outcomes
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All clinical trioals (CTs) listed in the Foods with Function Claims (FFC) notification information on the Consumer Affairs Agency (CAA) website during the period from January 1 to August 31, 2026, will be included.
Key exclusion criteria
When a single notification contains multiple types of evidence, such as both an systematic review (SR) and a CT (e.g., a double claim), only the CT will be included, and the SR will be excluded. If the same paper has been used by multiple companies or other entities to submit a notification for the same functional ingredient, it will be counted only once to avoid double counting.
Target sample size
1000
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 Sciences
Zip code
156-8502
Address
1-1-1 Sakuragaoka, 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 Sciences
Zip code
156-8502
Address
1-1-1 Sakuragaoka, 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
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Rview Board, Tokyo University of Agriculture
Address
1-1--1 Sakuragaoka, Setagaya-ku, Tokyo
Tel
0354772532
rs206125@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
| 2026 | Year | 08 | Month | 22 | Day |
Related information
URL releasing protocol
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
| 2026 | Year | 08 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Check out the full protocol at the following URL.
https://www.dropbox.com/scl/fi/z54gv8eupfo2aax4q0zu1/CONSORT2025.pdf?rlkey=ropuh4ggfktwio47c92umw4gl&st=zb4315wy&dl=0
Management information
Registered date
| 2026 | Year | 08 | Month | 22 | Day |
Last modified on
| 2026 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071722
