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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031641
Receipt No. R000036131
Scientific Title Assessment of the effect of improving the enteral environment by foods believed to potentially have such an effect
Date of disclosure of the study information 2018/03/12
Last modified on 2018/12/21

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Basic information
Public title Assessment of the effect of improving the enteral environment by foods believed to potentially have such an effect
Acronym Enteral environment improvement effect of foods believed to have such an effect
Scientific Title Assessment of the effect of improving the enteral environment by foods believed to potentially have such an effect
Scientific Title:Acronym 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
1st name
Middle name
Last name Prof. Shunji Mizobuchi
Organization Kochi Medical School, Kochi University
Division name Clinical nursing
Zip code
Address Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
TEL 088-866-5811
Email mizoshun@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shunji Mizobuchi
Organization Kochi Medical School, Kochi University
Division name Clinical nursing
Zip code
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)

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 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

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 Completed
Date of protocol fixation
2018 Year 02 Month 28 Day
Date of IRB
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

Other
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

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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