UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041187
Receipt No. R000044333
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
Date of disclosure of the study information 2021/03/15
Last modified on 2021/04/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.