UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055686 |
|---|---|
| Receipt number | R000063638 |
| Scientific Title | Reporting quality of systematic reviews submitted for Foods with Functional Claims in Japan: evaluation based on PRISMA 2020 and PRISMA-P |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2025/04/03 10:14:25 |
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Basic information
Public title
Reporting quality of systematic reviews submitted for Foods with Functional Claims in Japan: evaluation based on PRISMA 2020 and PRISMA-P
Acronym
Reporting quality of systematic reviews submitted for Foods with Functional Claims in Japan
Scientific Title
Reporting quality of systematic reviews submitted for Foods with Functional Claims in Japan: evaluation based on PRISMA 2020 and PRISMA-P
Scientific Title:Acronym
Reporting quality of systematic reviews submitted for Foods with Functional Claims in Japan
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify whether systematic reviews (SRs) published on the Consumer Affairs Agency (CAA) website after April 2024 have been appropriately described using PRISMA 2020, a guideline checklist for SR reporting published in 2021, and PRISMA-P, a checklist for SR protocol published in 2015.
Basic objectives2
Others
Basic objectives -Others
Nothing
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Each item in the PRISMA 2020 and PRISMA-P checklis
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 submitted papers based on SRs published on the CAA website during the period from April 1, 2024 to September 30, 2024 will be eligible.
Key exclusion criteria
As of September 2024, there is a grace/transition period for use of the new PRISMA 2020 edition instead of the old 2009 edition in the guidelines for the functional food labeling system5), therefore, SRs based on the old edition will be excluded and only SRs based on the new edition will be subject to evaluation. If there is overlap, such as multiple notifications using the same SR as proof of functionality, only the first SR will be accepted.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroharu |
| Middle name | |
| Last name | Kamioka |
Organization
Tokyo Universityu of Agriculture
Division name
Department of Regional Environment Science
Zip code
156-8502
Address
Sakuragaoka 1-1-1, Setagaya-ku, Tokyo
TEL
09069522690
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
Hiroharu Kamioka
Funding Source
Organization
Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology (MEXT), Japan
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
0354772587
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 | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://1drv.ms/b/s!AoQmpnIHE3YUhOxrhcEa_5wP8WHpZw?e=yEGdfO
Publication of results
Published
Result
URL related to results and publications
https://www.lifescience.co.jp/yk/jpt_online/j20250105.pdf
Number of participants that the trial has enrolled
40
Results
Among the PRISMA 2020 checklist items, 11 were commonly lacking in more than 40% of the SRs surveyed. The average total number of DBs used in this study was 4.9 (range: 2-14). All submitted SRs were registered in UMIN-CTR as a DB for research registration. However, UMIN-CTR had significantly fewer items specified as SRs than PRISMA-P (PRISMA 2020 compatible version), which led to incomplete or insufficient entries.
Results date posted
| 2025 | Year | 04 | Month | 03 | 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
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Refer to the detail protocol:
https://1drv.ms/b/s!AoQmpnIHE3YUhOxrhcEa_5wP8WHpZw?e=yEGdfO
Management information
Registered date
| 2024 | Year | 10 | Month | 01 | Day |
Last modified on
| 2025 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063638
