Healthy Japanese
Conditions
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals aged 20 or more and less than 65 at the time of agreement to participate in this study 6. Individuals who defecate three to five times per week at screening period 7. Individuals who eat three meals per day with a mealtime variation of less than two hours throughout the week. 8. Individuals whose BMI is less than 30 kg/m2
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Defecation frequency and number of days with defecation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed