UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Consideration of an effect food in bowel habits.
Title of the study (Brief title)	Consideration of an effect food in bowel habits.
Region	Japan

Condition
Condition	bowel habits
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We examine the relevance of the food for defecation ease and feces of shape.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	Evaluation item is carried out by the food record and defecation record.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	5
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Food
Interventions/Control_1	The subjects are divided into five groups, split into four types of sample administrartion group and control group.
Interventions/Control_2	Samples1 are administered and evaluated.
Interventions/Control_3	Samples2 are administered and evaluated.
Interventions/Control_4	Samples3 are administered and evaluated.
Interventions/Control_5	Samples4 are administered and evaluated.
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Subject is healthy, that you are not taking a laxative and antibiotic.
Key exclusion criteria	That it is taking laxatives and antibiotics.
Target sample size	20

Research contact person
Name of lead principal investigator	Etsuro Tanaka
Organization	Tokyo University Of Agriculture Faculty Of Applied Bio-Science Nutritional Science
Division name	Clinical Nutrition Laboratory
Address	Setagaya-ku, Tokyo Sakuragaoka 1-1-1
TEL	03-5477-2455
Email	etanaka-circ@umin.ac.jp

Public contact
Name of contact person	Etsuro Tanaka
Organization	Tokyo University Of Agriculture Faculty Of Applied Bio-Science Nutritional Science
Division name	Clinical Nutrition Laboratory
Address	Setagaya-ku, Tokyo Sakuragaoka 1-1-1
TEL	03-5477-2455
Homepage URL
Email	etanaka-circ@umin.ac.jp

Sponsor
Institute	Tokyo University Of Agriculture Faculty Of Applied Bio-Science Nutritional Science Clinical Nutrition Laboratory
Institute
Department

Funding Source
Organization	Tokyo University Of Agriculture Faculty Of Applied Bio-Science Nutritional Science Clinical Nutrition Laboratory
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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	東京農業大学応用生物科学部栄養科学科臨床栄養学研究室

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 05 Day
Anticipated trial start date	2016 Year 07 Month 05 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

Management information
Registered date	2016 Year 07 Month 05 Day
Last modified on	2018 Year 10 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026540