Effects of consumption of the test food on bowel movement in healthy Japanese
- Conditions
- Healthy Japanese
- Registration Number
- JPRN-UMIN000052997
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 88
Not provided
Individuals (who) 1. under treatment for malignancy, heart failure, and myocardial infarct/with a medical history of them 2. have a pacemaker/an implantable cardioverter defibrillator 3. under treatment for chronic diseases 4. take "Foods for Specified Health Uses"/"Foods with Functional Claims"/medications/herbal medicines/supplements (may affect the study) and cannot avoid taking during the study 5. are at risk of developing an allergy to the test food's ingredients 6. are pregnant/lactating/planning to become pregnant during the study 7. have diseases that may substantially affect bowel movement 8. enrolled in other studies within 28 days before agreeing to participate/plan to participate another study during the study 9. are judged as ineligible to participate by the physician 10. are smokers/quit smoking within a year before agreeing to participate 11. drink >=60-g/day of alcohol 12. are planning to relocate (for work/education)/events with unusual stress/living with family members who plan them 13. live with infants or care recipients 14. sleep with children aged 1~6 years or with care recipients 15. plan an unusual overnight stay during the study 16. are restricted to go to the restroom 17. have extremely irregular lifestyle habits 18. are judged as ineligible to participate from clinical measurements at screening 19. exercise for >=30 min at least twice a week to maintain/improve physical strength 20. have weight variated 5 kg or over within 2 months 21. eat extremely unbalanced diet 22. have irregular lifestyle due to night work/shift work/others 23. plan to change their lifestyle (exercise/eating habits) during the study 24. have taken health oils (e.g., coconut oil/medium chain triglyceride oil) possibly rich in the ingredients assessed in the study within 3 months/are currently taking 25. take foods rich in ingredients (may affect bowel movements/research field) 4 days weekly or more 26. sometimes substitute sweets or nutritional jellies for meals
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Defecation frequency and number of days with defecation
- Secondary Outcome Measures
Name Time Method 1. Amount of defecation, original questionnaire about bowel movement measured by visual analogue scale (VAS), health-related quality of life, stool shape, stool color, stool smell, and exhilarating feeling of defecation