UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017038
Receipt number 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 12:14:21

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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 or person

Institute

Faculty of Regional Environment Science, Tokyo University of Agriculture

Institute

Department

Personal name



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

Value
https://center6.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