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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017038
Receipt No. R000019758
Scientific Title Quality of systematic reviews of the Food with Function Claims (FFC, Kinosei-Hyoji-Shokuhin) registered at CAA website in Japan: prospective systematic review starting April 2015
Date of disclosure of the study information 2015/04/04
Last modified on 2017/08/01

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Basic information
Public title Quality of systematic reviews of the Food with Function Claims (FFC, Kinosei-Hyoji-Shokuhin) registered at CAA website in Japan: prospective systematic review starting April 2015
Acronym Quality of systematic reviews of the Food with Function Claims (FFC, Kinosei-Hyoji-Shokuhin)
Scientific Title Quality of systematic reviews of the Food with Function Claims (FFC, Kinosei-Hyoji-Shokuhin) registered at CAA website in Japan: prospective systematic review starting April 2015
Scientific Title:Acronym Quality of systematic reviews of the Food with Function Claims (FFC, Kinosei-Hyoji-Shokuhin)
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 of systematic reviews (SRs) based on the Food with Function Claims (FFC, Kinosei-Hyoji-Shokuhin) registered at CAA website in Japan.
Basic objectives2 Others
Basic objectives -Others We will evaluate heterogeneity and publication bias based on the results of meta-analyses.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes We are interested in the accuracy of the implementation and description of SR on the FFC. We will evaluate each claim report by the AMSTAR checklist (Shea BJ, et al., 2007) and the PRISMA statement (Liberate A, et al., 2009).
Key secondary outcomes We will describe the basic statistics for all general items in claimed reports. Example of the contents are as follows; number of reviewers and their expertise (with searcher), and number of databases used and their names. We will also analyze every same ingredient (e.g. lycopene, lutein).

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 We will search the following database from 1 May, 2015 (the predicted publish due date) up to 31 October, 2015: the CAA website. Studies will be eligible if they are SRs based on the FFC registered at the CAA website.
Key exclusion criteria Nothimg.
Target sample size

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
Email 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
Email h1kamiok@nodai.ac.jp

Sponsor
Institute Faculty of Regional Environment Science, Tokyo University of Agriculture
Institute
Department

Funding Source
Organization We are searching for a funding source.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Review team
Professor Kiichiro Tsutani, Tokyo Ariake Medical and Health Science University
Professor Hideki Origasa, Biostatistics and Clinical Epidemiology, University of Toyama School of Medicine
Dr. Takahiro Yoshizaki, Department of Nutritional Science, Department of Toyo University
Mr Wentao Tang, Department of Drug Policy and Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo
Ms Mikiko Shimada, Medical corporation Hidaka Rehabilitation Hospital
Mr Jun Kitayuguchi, Physical Education and Medicine Research Center Unnan
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 04 Month 04 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
Results
The quality of the SRs was in the poor description category (mean; 6.2 pts, SD; 1.8pts, range 2-18 pts). See the following article and report. 
Kamioka H et al. Quality of systematic reviews of the Foods with Function Claims registered at the Consumer Affairs Agency website in Japan: a prospective systematic review. Nutrition Research 40;2017:21-31. 
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
2015 Year 04 Month 03 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Regarding the evaluation by the PRISMA checklist, it was performed as a research by the CAA of Japan.
http://www.caa.go.jp/foods/pdf/food_with_function_report_0003.pdf

Management information
Registered date
2015 Year 04 Month 03 Day
Last modified on
2017 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019758

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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