A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study of Effects of Daily Ingestion of Powdered Plant on Bowel Movement.
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000024504
- Lead Sponsor
- Hokkaido Information University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 63
Not provided
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 regularly take anticoagulants (e.g., warfarin). 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 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 obvious physical changes. 9. Subjects who are at risk of having allergic reactions to drugs or foods (especially gramineous plants such as rice, flour and corn). 10. Subjects who regularly take drugs, functional foods and/or supplements (containing lactic acid bacteria, bifidobacterium, oligosaccharides, dietary fiber, etc.) which potentially affect bowel movements. 11. Subjects who cannot abstain from taking any of health-oriented foods (including Food for Specified Health Uses), fortified foods with dietary fiber or oligosaccharide, yoghurt, lactic acid bacteria beverage, natto during this study. 12. Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 13. Subjects who donated either 400ml whole blood within 12 weeks (men) /16 weeks (women) or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to the current study. 14. Pregnant or lactating women or women expect to be pregnant during this study. 15. Subjects who currently participate in other clinical trials or participated within the last 4 weeks prior to the current study. 16. Any other medical and/ or health reasons unfavorable to participation into the current study judged by the principal investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Defecation frequency at 1 week and 2 weeks after ingestion of test meals.
- Secondary Outcome Measures
Name Time Method Stool amount, stool shape, stool color, stool odor, feeling after defecation, VAS questionnaire.