UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Daily Intake of Test Food on Intestinal Environment : A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Acronym	Effect of Daily Intake of Test Food on Intestinal Environment
Scientific Title	Effect of Daily Intake of Test Food on Intestinal Environment : A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Scientific Title:Acronym	Effect of Daily Intake of Test Food on Intestinal Environment
Region	Japan

Condition
Condition	Healthy Adult
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To prove the effect of test food on intestinal environment associated with 4 week daily intake in a randomized, double-blind, placebo-controlled, parallel group study.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Bowel diary at 4 weeks after beginning the intake of test food.
Key secondary outcomes	Intestinal flora, gut metabolome, heart rate variability, sleeping record, electroencephalogram during sleeping, survey on subjects' sleeping and mental and physical conditions, blood metabolome, analysis of fecal samples, the Japanese version of constipation assessment scale MT version (CAS-MT), blood inflammatory marker.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Daily ingestion 5 tablets of active test food for 4 weeks.
Interventions/Control_2	Daily ingestion 5 tablets of placebo test food for 4 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	65 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 with ailment on defecation.
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. 3. Subjects who use gastrointestinal drugs or female hormone once or more a week. 4. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 5. Subjects with major surgical history relevant to the digestive system. 6. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 7. Subjects with severe anemia. 8. Pre- or post-menopausal women complaining of obvious physical changes. 9. Subjects who repeat constipation and diarrhea. 10. Subjects with defecation frequency 3 or less/ 9 or more per weeks. 11. Subjects with stool characteristics (Bristol scale) 5 or more. 12. Subjects who have habit to consume yogurt 6 days or more per week. 13. Subjects who have habit to consume beverages include lactic acid bacteria and/or bifidobacteria 2 days or more per week. 14. Subjects who have habit to consume beverages include dietary fiber reinforced food and/or oligo sugar 1 day or more per week. 15. Subjects who have allergy to drugs or foods especially based on soybean and yeast. 16. Subjects who used antibiotics within 12 weeks, prior to the current study. 17. Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 18. 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 week, prior to the study. 19. Pregnant or lactating women or women who expect to be pregnant during this study. 20. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the study. 21. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Naoyuki Middle name Last name HONMA
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	hisc-acad.res@s.do-johodai.ac.jp

Public contact
Name of contact person	1st name Naoyuki Middle name Last name HONMA
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	hisc-acad.res@s.do-johodai.ac.jp

Sponsor
Institute	Hokkaido Information University
Institute
Department

Funding Source
Organization	National Agriculture and Food Research Organization
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 National Institute of Advanced Industrial Science and Technology Bioresource and Bioenvironment Kyushu University
Name of secondary funder(s)	Asahi Quality & Innovations, Ltd.

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	2022 Year 08 Month 05 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	2021 Year 04 Month 28 Day
Date of IRB	2021 Year 04 Month 28 Day
Anticipated trial start date	2021 Year 06 Month 30 Day
Last follow-up date	2021 Year 09 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 05 Month 11 Day
Last modified on	2022 Year 04 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050427