Effect of Daily Intake of Test Food on Intestinal Environment : A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
- Conditions
- Healthy Adult
- Registration Number
- JPRN-UMIN000044175
- Lead Sponsor
- Hokkaido Information University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
1. Subjects with a clinical history of gastrointestinal cancer or currently under treatment or anti-tumor medication. 2. Subjects with gastrointestinal disorders. 3. Subjects who use gastrointestinal drugs or female hormone once or more a week. 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. 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 repeat constipation and diarrhea. 10. Subjects with defecation frequency 3 or less/ 9 or more per weeks. 11. Subjects with stool characteristics (Bristol scale) 5 or more. 12. Subjects who have habit to consume yogurt 6 days or more per week. 13. Subjects who have habit to consume beverages include lactic acid bacteria and/or bifidobacteria 2 days or more per week. 14. Subjects who have habit to consume beverages include dietary fiber reinforced food and/or oligo sugar 1 day or more per week. 15. Subjects who have allergy to drugs or foods especially based on soybean and yeast. 16. Subjects who used antibiotics within 12 weeks, prior to the current study. 17. Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 18. 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 week, prior to the study. 19. Pregnant or lactating women or women who expect to be pregnant during this study. 20. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the study. 21. 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
- Secondary Outcome Measures
Name Time Method