Effect of Daily Ingestion of Test Food on Improving Gut Microbiota: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
- Conditions
- Healthy Adult
- Registration Number
- JPRN-UMIN000042745
- Lead Sponsor
- Hokkaido Information University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 24
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 may cause some skin troubles by measuring electroencephalogram and/or heart rate variability. 4. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 5. Subjects who take digoxin. 6. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 7. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 8. Subjects with severe anemia. 9. Pre- or post-menopausal women complaining of obvious physical changes. 10. Subjects who are at risk of having allergic reactions to drugs or foods especially based on wheat, milk, and egg. 11. Subjects who regularly take drugs, functional foods and/or supplements which potentially affect bowel movements and/or gut microbiota. 12. Subjects who regularly take staple food with high dietary fiber. 13. Subjects who regularly take yoghurt, lactic acid bacteria beverage, and natto. 14. Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 15. Subjects who have used antibiotics within 12 weeks prior to the current study. 16. Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks, or blood components within 2 weeks, prior to the current study. 17. Pregnant or lactating women or women who expect to be pregnant during this study. 18. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study. 19. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Defecation frequency and gut microbiota at 4 weeks after beginning the intake of test food.
- Secondary Outcome Measures
Name Time Method Bowel diary, Heart rate variability, VAS questionnaire on stress, electroencephalogram during sleeping, sleeping record