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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045685
Receipt No. R000052143
Scientific Title Compliance of clinical trial protocols for Foods with Function Claims in Japan: consistency between information in clinical trial registrations and published reports
Date of disclosure of the study information 2021/10/11
Last modified on 2021/10/06

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Basic information
Public title Were clinical trials for Foods with Function Claims based on the protocols?
Acronym Clinical trial protocols for Foods with Function Claims
Scientific Title Compliance of clinical trial protocols for Foods with Function Claims in Japan: consistency between information in clinical trial registrations and published reports
Scientific Title:Acronym Compliance of clinical trial protocols for Foods with Function Claims in Japan
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to clarify the compliance of clinical trial protocols reported as the scientific basis of efficacy in the FFC system. Based on results, the issues necessary to improve clinical trials protocol compliance will be specified.
Basic objectives2 Others
Basic objectives -Others Nothing.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The following data items will be collected: author characteristics (company-based researchers or academia researchers, or other), journal name, year published, journal impact factor (IF) in 2020, language of the article, name of CTR, and seven compliance items (PICOS, Ethics review Implementation, and IC).
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 All reported articles based on clinical trials published on the CAA website during the three years from July 1, 2018 to June 30, 2021 will be reviewed.
Key exclusion criteria We will exclude articles that are about systematic reviews and observational studies. Since there are duplicates, such as multiple notifications using the same article, only the first article will be adopted in such cases.
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 Department of Ecological Symbiotic Science, Graduate School of Agriculture
Zip code 156-8502
Address Sakuragaoka 1-1-1, Setagaya-ku, Tokyo
TEL +81354772587
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 Department of Ecological Symbiotic Science
Zip code 156-8502
Address Sakuragaoka 1-1-1, Setagaya-ku, Tokyo
TEL +81354772587
Homepage URL
Email h1kamiok@nodai.ac.jp

Sponsor
Institute Tokyo University of Agricultre
Institute
Department

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 Tokyo University of Agriculture
Address Sakuragaoka 1-1-1, Setagaya-ku, Tokyo
Tel +81354772587
Email h1kamiok@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
2021 Year 10 Month 11 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 Preinitiation
Date of protocol fixation
2021 Year 10 Month 04 Day
Date of IRB
Anticipated trial start date
2021 Year 10 Month 11 Day
Last follow-up date
2021 Year 10 Month 30 Day
Date of closure to data entry
2021 Year 11 Month 15 Day
Date trial data considered complete
2021 Year 11 Month 15 Day
Date analysis concluded
2021 Year 11 Month 30 Day

Other
Other related information The purpose of this study is to clarify the following points for 177 clinical trial-based publications on the Consumer Affairs Agency (CAA) website from July 1, 2018 to June 30, 2021.
i) What percentage of studies have pre-registered clinical trials? How many protocols are available for unregistered studies?
ii) What is the degree of compliance, that is, the degree of consistency about PICOS* between the protocol and the description of articles? What are the items and their characteristics that often violate the protocol?
iii) Is compliance correlated with author characteristics (corporate authors, academia authors), the year in which the paper was published, the relationship between English and other languages, and the impact factor?
From these points, it will be necessary to clarify the challenges for improving clinical trials for the FFC.
* Participant: P, Intervention: I, Comparison: C, Outcome: O, and Study design: S.

Please see the following URL about the complete protocol of this study.
https://drive.google.com/file/d/16aHdFVH7RGS3gbdFkYa2qjsZu9mrTbmC/view?usp=sharing

Management information
Registered date
2021 Year 10 Month 06 Day
Last modified on
2021 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052143

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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