UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029821 |
|---|---|
| Receipt number | R000034069 |
| Scientific Title | Quality of systematic reviews of the Foods with Function Claims (FFC, Kinosei-Hyoji-Shokuhin) in Japan: comparative before- and after- evaluation on the verification reports by the Consumer Affairs Agency (CAA) |
| Date of disclosure of the study information | 2017/11/04 |
| Last modified on | 2019/11/08 13:34:56 |
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Basic information
Public title
Quality of systematic reviews of the Foods with Function Claims (FFC, Kinosei-Hyoji-Shokuhin) in Japan: comparative before- and after- evaluation on the verification reports by the Consumer Affairs Agency (CAA)
Acronym
Quality of systematic reviews of the Foods with Function Claims
Scientific Title
Quality of systematic reviews of the Foods with Function Claims (FFC, Kinosei-Hyoji-Shokuhin) in Japan: comparative before- and after- evaluation on the verification reports by the Consumer Affairs Agency (CAA)
Scientific Title:Acronym
Quality of systematic reviews of the Foods with Function Claims
Region
| Japan |
Condition
Condition
This study will be a review based on systematic reviews (SRs). The study will be restricted to all original SRs of healthy adults.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this review is to assess the quality systematic reviews (SRs) based on the FFC registered at CAA website in Japan and to determine whether the CAA's verification report in 2016 is associated with improvement in the quality of SRs.
Basic objectives2
Others
Basic objectives -Others
Not applicable.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
We will evaluate each SR by the AMSTAR checklist (Shea BJ, et al., 2007) and the AMSTAR 2 (Shea BJ, et al., 2017) on methodological quality and the PRISMA checklist (Liberate A, et al., 2009) on reporting quality, respectively.
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
Studies will be eligible if they are SRs based on the FFC registered at the CAA website. We will search the database from 1 April, up to 31 October, 2015 as the pre-SR and from 1 July, 2017 up to 31 January, 2018 as the post-SR. Actually, the pre-SR was evaluated by the CAA according to the PRISMA checklist and our research group (FFC-SR2) according to the AMSTAR checklist. We will make use of each statistical data as results of pre-evaluation. Furthermore, we will add an evaluation by the AMSTAR 2 that was developed newly.
Key exclusion criteria
We will exclude SRs based on observational studies such as cohort study and case-control study. We will exclude SRs of the same content registered in order to submit any other final products on a post SR. And we will also exclude only a minor-revised SR for an original SR on the pre-.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroharu Kamioka |
Organization
Tokyo University of Agriculture
Division name
Faculty of Regional Environment Science
Zip code
Address
Sakuragaoka 1-1-1, Setagayaku, Tokyo, Japan
TEL
03-5477-2587
h1kamiok@nodai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroharu Kamioka |
Organization
Tokyo University of Agriculture
Division name
Faculty of Regional Environment Science
Zip code
Address
Sakuragaoka 1-1-1, Setagayaku, Tokyo, Japan
TEL
03-5477-2587
Homepage URL
h1kamiok@nodai.ac.jp
Sponsor or person
Institute
Faculty of Regional Environment Science, Tokyo University of Agriculture
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Science Research ( C ) Number 17K00885 from the Ministry of Education, Culture, Sports, Science, and Technology, 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
Address
Tel
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
| 2017 | Year | 11 | Month | 04 | 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
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 11 | Month | 20 | Day |
Other
Other related information
Review team and each personal role
Prof. Hiroharu Kamioka (HK), Prof. Kiichiro Tsutani (KT), Prof. Hideki Origasa (HO), Prof. Hiromi Takano-Ohmuro (HT-O), Dr. Takahiro Yoshizaki (TY),Dr. Mikiko Shimada (MS), Dr. Jun Kitayuguchi (JK), Dr. Yasuyo Wada (YW), Ms. Mari Makishi (MM) and Ms. Satoko Sayama (SS).
For the evaluation by each AMSTAR, writing protocols and articles and administration; HK, quality evaluations; TY, MS, JK, YW, HT-O, HO, and KT, statistical analysis; JK and TY, research methodological guarantors; KT and HO.
The study project by the PRISMA includes two parts. The 1st part is a comprehensive review concerning whole content and the 2nd part is specific research subjects divided each research item. Each first author is the following: a comprehensive review; HK, introduction; YW, data extraction; MS, databases; MM, search method; SS, meta-analysis; HO, bias risk; JK, quality of evidence; TY, and validity of function claim; HT-O.
Management information
Registered date
| 2017 | Year | 11 | Month | 04 | Day |
Last modified on
| 2019 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034069
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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