UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Systematic Review of The Effect of Ingredient from Wheat on Intestinal Function
Title of the study (Brief title)	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	Mochida, Key
Organization	RCT Japan Co., Ltd.
Division name	R&D
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	Mochida, Key
Organization	RCT Japan Co., Ltd.
Division name	R&D
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 01 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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