UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000049558
Receipt number R000056439
Scientific Title A cross-sectional study on systematic reviews of Foods with Functional Claims (FFC) in Japan: quality assessment using AMSTAR 2
Date of disclosure of the study information 2022/11/19
Last modified on 2023/05/20 09:47:55

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Basic information

Public title

A cross-sectional study on systematic reviews of Foods with Functional Claims (FFC): quality assessment using AMSTAR 2

Acronym

Research quality on systematic reviews of Foods with Functional Claims

Scientific Title

A cross-sectional study on systematic reviews of Foods with Functional Claims (FFC) in Japan: quality assessment using AMSTAR 2

Scientific Title:Acronym

Research quality on systematic reviews of Foods with Functional Claims

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to clarify research quality by the AMSTAR 2 of SRs reported as the scientific basis of efficacy in the FFC system. The results will determine the methodological quality of SRs based on the necessary improvements.

Basic objectives2

Others

Basic objectives -Others

The purpose of this study is to clarify research quality by the AMSTAR 2 of SRs reported as the scientific basis of efficacy in the FFC system. The results will determine the methodological quality of SRs based on the necessary improvements.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

AMSTAR 2 (16 items)

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

All reported articles SR published on the CAA website during the one year from April 1, 2022 to October 31, 2022 will be reviewed.

Key exclusion criteria

We will exclude clinical and observational studies.

Target sample size



Research contact person

Name of lead principal investigator

1st name Hiroharu
Middle name
Last name Kamioka

Organization

Tokyo University of Agriculture

Division name

Faculty of Regional Environment Science

Zip code

156-8502

Address

Sakuragaoka 1-1-1, Setagaya-ku, Tokyo

TEL

0354772587

Email

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

Faculty of Regional Environment Science

Zip code

1568502

Address

Sakuragaoka 1-1-1, Setagaya-ku, Tokyo

TEL

0354772587

Homepage URL


Email

h1kamiok@nodai.ac.jp


Sponsor or person

Institute

Tokyo University of Agriculture

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology (MEXT)

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 of Tokyo University of Tokyo

Address

Sakuragaoka 1-1-1, Setagaya-ku, Tokyo

Tel

0354773794

Email

yyoshi@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

2022 Year 11 Month 19 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

2022 Year 11 Month 19 Day

Date of IRB

2022 Year 11 Month 01 Day

Anticipated trial start date

2022 Year 12 Month 06 Day

Last follow-up date

2022 Year 12 Month 25 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

You can check the protocol and results in the following URL.
https://1drv.ms/b/s!AtViZRADbyukiG7zFy8oShYcWxRF?e=xgKqjL
https://www.mdpi.com/2072-6643/15/9/2047


Management information

Registered date

2022 Year 11 Month 19 Day

Last modified on

2023 Year 05 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056439