UMIN-CTR Clinical Trial

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