UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031641 |
|---|---|
| Receipt number | 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 08:02:36 |
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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
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
mizoshun@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036131
