UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of the effect of improving the enteral environment by foods believed to potentially have such an effect
Title of the study (Brief title)	Enteral environment improvement effect of foods believed to have such an effect
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective was to evaluate the effect on bowel movements by consuming foods believed to improve the enteral environment on bowel movements.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Defecation frequency, defecation quantity, stool form, stool hardness, stool color, stool odor, and post-defecation feeling
Key secondary outcomes	1. Fecal flora (Lactobacillus, Bifidobacterium) 2. Anti-metabolic syndrome effect (LDL cholesterol, triglycerides, HDL cholesterol, fasting blood sugar, insulin, HbA1c)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Subjects consume two pieces of food believed to improve the enteral environment daily for 12 weeks.
Interventions/Control_2	Subjects consume two pieces of a placebo food daily for 12 weeks.
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	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1. Those who receive an appropriate explanation of the purpose and content of the study, are able to consent, voluntarily request to participate after gaining a full understanding, and are able to consent to participation in this survey in writing. 2. Healthy individuals with a defecation frequency of 2 to 5 times per week, inclusive.
Key exclusion criteria	Individuals meeting any of the following conditions will not be selected as study subjects: 1. Pregnant and nursing mothers, and individuals with a desire to become pregnant during the study period 2. Individuals taking medication on a routine basis 3. Individuals who are taking foods for specific health use, foods with function claims, and/or health foods, in the case that such foods affect gastrointestinal function 4. Individuals with persistent diarrhea. 5. Individuals with a fruit allergy 6. Individuals whose fasting blood test results during a physical examination include: blood glucose >=126 mg/dL, LDL cholesterol >=140 mg/dL, triglycerides >=150 mg/dL, or HDL cholesterol <40 mg/dL 7. Other individuals deemed unsuitable by the principal investigator.
Target sample size	100

Research contact person
Name of lead principal investigator	Prof. Shunji Mizobuchi
Organization	Kochi Medical School, Kochi University
Division name	Clinical nursing
Address	Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
TEL	088-866-5811
Email	mizoshun@kochi-u.ac.jp

Public contact
Name of contact person	Shunji Mizobuchi
Organization	Kochi Medical School, Kochi University
Division name	Clinical nursing
Address	Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
TEL	088-880-2564
Homepage URL
Email	mizoshun@kochi-u.ac.jp

Sponsor
Institute	Kochi University
Institute
Department

Funding Source
Organization	Public Interest Incorporated Foundation KOCHI INDUSTRIAL PROMOTION CENTER
Organization
Division
Category of Funding Organization	Other
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	高知大学医学部（高知県）、高知大学医学部附属病院（高知県）、医療法人 仁泉会 朝倉病院（高知県）、医療法人 浦松会 南国厚生病院（高知県）

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 28 Day
Anticipated trial start date	2018 Year 03 Month 12 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	2018 Year 03 Month 08 Day
Last modified on	2018 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036131