Healthy adults
Conditions
Interventions
Daily ingestion 3 g of the Dietary fiber made from rice bran for 4 weeks.
Sponsors
Hokkaido Information University
Bioresource and Bioenvironment Kyushu University, Kirin Holdings Company, Limited
Eligibility
Sex/Gender
Female
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation frequency after 4 weeks of ingestion. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactJun NISHIHIRA
Hokkaido Information University Health Information Science Center
Outcome results
None listed