UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041187 |
|---|---|
| Receipt number | 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 16:32:36 |
* 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
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
nishihira@do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
