UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Daily Ingestion of Test Food on Improving Gut Microbiota: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Acronym	Beneficial Effects of Test Food on Improving Gut Microbiota
Scientific Title	Effect of Daily Ingestion of Test Food on Improving Gut Microbiota: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Scientific Title:Acronym	Beneficial Effects of Test Food on Improving Gut Microbiota
Region	Japan

Condition
Condition	Healthy Adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate clinical benefits associated with 4 weeks daily ingestion of the test food on improving gut microbiota in a randomized, double-blind, placebo-controlled, parallel group study.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Defecation frequency and gut microbiota at 4 weeks after beginning the intake of test food.
Key secondary outcomes	Bowel diary, Heart rate variability, VAS questionnaire on stress, electroencephalogram during sleeping, sleeping record

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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Daily ingestion 180 g of test food (low dose) for 4 weeks.
Interventions/Control_2	Daily ingestion 180 g of test food (high dose) for 4 weeks.
Interventions/Control_3	Daily ingestion 180 g of placebo food for 4 weeks.
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	1. Subjects who agree to participate in this study with a written informed consent. 2. Subjects who are aware of having a tendency toward constipation. 3. Subjects with defecation frequency less than 5 times per week.
Key exclusion criteria	1. Subjects with a clinical history of gastrointestinal cancer or currently under treatment or anti-tumor medication. 2. Subjects with gastrointestinal disorders such as inflammatory bowel syndrome, irritable bowel syndrome, etc. 3. Subjects who may cause some skin troubles by measuring electroencephalogram and/or heart rate variability. 4. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 5. Subjects who take digoxin. 6. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 7. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 8. Subjects with severe anemia. 9. Pre- or post-menopausal women complaining of obvious physical changes. 10. Subjects who are at risk of having allergic reactions to drugs or foods especially based on wheat, milk, and egg. 11. Subjects who regularly take drugs, functional foods and/or supplements which potentially affect bowel movements and/or gut microbiota. 12. Subjects who regularly take staple food with high dietary fiber. 13. Subjects who regularly take yoghurt, lactic acid bacteria beverage, and natto. 14. Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 15. Subjects who have used antibiotics within 12 weeks prior to the current study. 16. Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks, or blood components within 2 weeks, prior to the current study. 17. Pregnant or lactating women or women who expect to be pregnant during this study. 18. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study. 19. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Jun Middle name Last name NISHIHIRA
Organization	Hokkaido Information University
Division name	Department of Medical Management and Informatics
Zip code	069-8585
Address	59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL	011-385-4411
Email	nishihira@do-johodai.ac.jp

Public contact
Name of contact person	1st name Jun Middle name Last name NISHIHIRA
Organization	Hokkaido Information University
Division name	Health Information Science Center
Zip code	069-8585
Address	59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL	011-385-4430
Homepage URL
Email	nishihira@do-johodai.ac.jp

Sponsor
Institute	Hokkaido Information University
Institute
Department

Funding Source
Organization	National Agriculture and Food Research Organization, bio-oriented technology Research Advancement Institution
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	National Agriculture and Food Research Organization
Name of secondary funder(s)	Nisshin Seifun Group Inc.

IRB Contact (For public release)
Organization	The ethics committee of Hokkaido Information University
Address	59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel	011-385-4411
Email	soumu@do-johodai.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	北海道情報大学　保健センター（北海道）

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 18 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	2020 Year 11 Month 25 Day
Date of IRB	2020 Year 11 Month 25 Day
Anticipated trial start date	2021 Year 01 Month 14 Day
Last follow-up date	2021 Year 03 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 12 Month 14 Day
Last modified on	2021 Year 04 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048765