UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Daily Ingestion of the Dietary Fiber made from Rice Bran on Bowel Movements and Improving Minor Ailments: An Open-Label, Uncontrolled Pilot Study
Acronym	Effect of Daily Ingestion of the Dietary Fiber made from Rice Bran on Bowel Movements and Improving Minor Ailments
Scientific Title	Effect of Daily Ingestion of the Dietary Fiber made from Rice Bran on Bowel Movements and Improving Minor Ailments: An Open-Label, Uncontrolled Pilot Study
Scientific Title:Acronym	Effect of Daily Ingestion of the Dietary Fiber made from Rice Bran on Bowel Movements and Improving Minor Ailments
Region	Japan

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

Objectives
Narrative objectives1	To prove clinical benefits and safety associated with 4 weeks daily ingestion of the dietary fiber made from rice bran on bowel movements, stress reducing and sleep improving in a open-label, uncontrolled study.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Defecation frequency after 4 weeks of ingestion.
Key secondary outcomes	Stoolvolume, stool shape, stool color, stool odor, feeling after defecation, gut flora, heart rate variability, Electroencephalogram during sleeping, blood metabolome, sleeping record (physical conditions before and after sleeping), nail cortisol, questionnaire about subjects' background information.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Daily ingestion 3 g of the Dietary fiber made from rice bran for 4 weeks.
Interventions/Control_2
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	30 years-old <=
Age-upper limit	65 years-old >
Gender	Female
Key inclusion criteria	1. Subjects who agree to participate in this study with a written informed consent. 2. Subjects with defecation frequency between minimum 3 to maximum 5 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 have used as needed or continued to use antibiotics within 3 months prior to screening test. 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 such as gastrectomy, gastrorrhaphy, enterectomy, etc. 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 are at risk of having allergic reactions to drugs or cedar pollen or foods especially based on soybean, pork, gelatin, egg, wheat, milk and apple. 10. Subjects who regularly take drugs, functional foods and/or supplements which potentially affect bowel movements. 11. Subjects who cannot abstain from taking any of health-oriented foods during the study period. 12. Subjects who cannot abstain from taking too much of oligosaccharide, dietary fiber, yoghurt, lactic acid bacteria beverage, natto during the study period. 13. Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 14. Subjects who donated either 400 ml whole blood within 16 weeks or 200 ml whole blood within 4 weeks or blood components within 2 weeks prior to the screening tests. 15. Pregnant or lactating women or women expect to be pregnant during this study. 16. Subjects who currently participate in other clinical trials or participated within the last 4 weeks prior to the current study. 17. Any other medical and/ or health reasons unfavorable to participation into the current study judged by the principal investigator.
Target sample size	30

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
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Bioresource and Bioenvironment Kyushu University, Kirin Holdings Company, Limited
Name of secondary funder(s)	Kirin Holdings Company, Limited

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

Other administrative information
Date of disclosure of the study information	2021 Year 03 Month 15 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	2019 Year 11 Month 26 Day
Date of IRB	2019 Year 09 Month 26 Day
Anticipated trial start date	2020 Year 01 Month 07 Day
Last follow-up date	2020 Year 03 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2021 Year 03 Month 15 Day

Other
Other related information

Management information
Registered date	2020 Year 07 Month 22 Day
Last modified on	2021 Year 04 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044333