UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Hiroharu Kamioka
Organization	Tokyo University of Agriculture
Division name	Faculty of Regional Environment Science
Address	Sakuragaoka 1-1-1, Setagayaku, Tokyo, Japan
TEL	03-5477-2587
Email	h1kamiok@nodai.ac.jp

Public contact
Name of contact person	Hiroharu Kamioka
Organization	Tokyo University of Agriculture
Division name	Faculty of Regional Environment Science
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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