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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035783
Receipt No. R000040759
Scientific Title Systematic Review of The Effect of Ingredient from Wheat on Intestinal Function
Date of disclosure of the study information 2019/02/10
Last modified on 2019/02/13

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Basic information
Public title Systematic Review of The Effect of Ingredient from Wheat on Intestinal Function
Acronym SR of Ingredient from Wheat on Intestinal Function
Scientific Title Systematic Review of The Effect of Ingredient from Wheat on Intestinal Function
Scientific Title:Acronym SR of Ingredient from Wheat on Intestinal Function
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the effect of intake of ingredient from wheat on intestinal function in healthy adults.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Intestinal Regulatory
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

Not applicable
Gender Male and Female
Key inclusion criteria Healthy adults
Key exclusion criteria Sick Person
Pregnant
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mochida, Key
Organization RCT Japan Co., Ltd.
Division name R&D
Zip code
Address Shibuya-Hikarie, 2-21-1, Shibuya, Shibuya-ku, Tokyo, Japan
TEL 03-3400-3200
Email info@rctjapan.org

Public contact
Name of contact person
1st name
Middle name
Last name Mochida, Key
Organization RCT Japan Co., Ltd.
Division name R&D
Zip code
Address Shibuya-Hikarie, 2-21-1, Shibuya, Shibuya-ku, Tokyo, Japan
TEL 03-3400-3200
Homepage URL
Email info@rctjapan.org

Sponsor
Institute Kino-Ken Co., Ltd.
Institute
Department

Funding Source
Organization RCT Japan Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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
2019 Year 02 Month 10 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
2018 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Condition of Systematic Review

Database: PubMed, Ichushi Web, etc

Key Words: Wheat derived component, Intestinal function

Management information
Registered date
2019 Year 02 Month 06 Day
Last modified on
2019 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040759

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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