UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037069 |
|---|---|
| Receipt number | R000042240 |
| Scientific Title | A Study on the Effect of Test Food on the Defecation and Intestinal flora |
| Date of disclosure of the study information | 2019/06/17 |
| Last modified on | 2021/01/28 10:12:09 |
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Basic information
Public title
A Study on the Effect of Test Food on the Defecation and Intestinal flora
Acronym
A Study on the Effect of Test Food on the Defecation and Intestinal flora
Scientific Title
A Study on the Effect of Test Food on the Defecation and Intestinal flora
Scientific Title:Acronym
A Study on the Effect of Test Food on the Defecation and Intestinal flora
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of test food on the defecation and intestinal flora
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire of defecation frequency and Bristol stool form scale
Key secondary outcomes
Variation of the intestinal flora, Questionnaire of QOL, Taste test of sweety
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Consume a test food.
Interventions/Control_2
Consume placebo food.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects who can understand the trial, make self-judgment and are voluntarily giving written informed consent.
2. Subjects with a tendency for constipation (at 2-5 times of defecation per week)
3. Subjects who can be considered appropriate for the participation on this exam by study physician.
Key exclusion criteria
1, Subjects who have the habit of taking a lot of vegetables ( more than 350g a day )
2, Subjects who cannot limit use of those (medicine (laxatives, intestinal preparation), a health food, a food for specified health use, functional indication food, a healthy supplement, a cereal, a supplement, a food containing lots of lactic acid bacterium or the oligosaccharide) which may influence the bowel movement after agreement acquisition.
3 , Subjects currently undergoing treatment with digestive diseases that affect the study or having a surgical history of digestive system (except appendicectomy)
4, Subjects who have diseases (irritable enteritis, ulcerative colitis, etc.) affecting bowel movement or a history of these diseases
5, Subjects having diseases (diabetes mellitus, liver disease, kidney disease, heart disease, etc.) or having a history of serious diseases, being treated under kinesiology and dietary cure under physician.
6, Subjects who have diseases that regularly needs medication or a history of serious diseases which needed medication treatment.
7, Subjects with drug allergy or alimentary allergy.
8, Subjects who are judged from the answer to background questionnaire to be inappropriate as a subject
9, Subjects who plan to become pregnant after informed consent for the current study or are pregnant or lactating.
10, Individuals who are judged by the study physician to be inappropriate as a subject.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Atsuhiko |
| Middle name | |
| Last name | Takahashi |
Organization
Nihon University Junior College
Division name
Department of Food and Nutrition, Advanced Course of Food and Nutrition
Zip code
411-8555
Address
2-31-145, bunkyo-cho, mishima City, Shizuoka
TEL
055-980-0840
takahashi.atsuhiko@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsuhiko |
| Middle name | |
| Last name | Takahashi |
Organization
Nihon University Junior College
Division name
Department of Food and Nutrition, Advanced Course of Food and Nutrition
Zip code
411-8555
Address
2-31-145, bunkyo-cho, mishima City, Shizuoka
TEL
055-980-0840
Homepage URL
takahashi.atsuhiko@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Junior College
Institute
Department
Personal name
Funding Source
Organization
Mizkan Holdings Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University College of International Relations Ethical Review Committee
Address
2-31-145, bunkyo-cho, mishima City, Shizuoka
Tel
055-980-0801
takahashi.atsuhiko@nihon-u.ac.jp
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 | 06 | Month | 17 | 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
29
Results
Results date posted
| 2021 | Year | 01 | Month | 28 | Day |
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
| 2019 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 14 | Day |
Last modified on
| 2021 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042240
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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