Healthy Japanese adults
Conditions
Interventions
Duration: 4 weeks Test materials: Konjac processed food Dose: 1 pack a day Administration: Take 1 pack in the morning. If you take breakfast, take the test food 15 minutes before breakfast. *If yo
Sponsors
ORTHOMEDICO Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adults 2. Those who defecate three to five times per week 3. Those who are considered as appropriate for the study by the physician 4. Among the people who passed 3., 3 or more male and 3 or more female are selected from each generation (20s, 30s, 40s, 50s, and 60s). (e.g., 6 or more people are selected from each generation.) 5. Among the people who passed 4., those who have relatively few defecation frequency during a week before screening and advance examination 6. Among the people who passed 5., those who have relatively high score in the Japanese version of Constipation Assessment Scale MT version (CAS-MT)
Exclusion criteria
Exclusion criteria: 1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily 4. Currently taking medicines and/or herbal medicines 5. Those who are allergic to medicines, milk, beans, orange, and/or other food products 6. Those who are pregnant, breast-feeding, and plan to become a pregnant 7. Those who had participated another clinical test for three months when you signed the informed consent form for this trial 8. Others considered as inappropriate for the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Bowel movement diary 2. The Japanese version of Constipation Assessment Scale MT version (CAS-MT) *1 Keep it from a week before screening test and a week before consuming to 4 weeks after consuming *2 Assess at 0 and 4 weeks after consuming | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Bacterial flora analysis (T-RFLP) 2. Bristol scale *1,2 Assess at 0 and 4 weeks after consuming | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed