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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037069
Receipt No. 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 2020/06/15

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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
Email 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
Email takahashi.atsuhiko@nihon-u.ac.jp

Sponsor
Institute Nihon University Junior College
Institute
Department

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
Email 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
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 No longer recruiting
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
2020 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042240

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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