Healthy Japanese adults
Conditions
Interventions
Duration: 4 weeks Test materials: Fermented plant extracts Dose: 3 packs per day (2 g x 3) Administration: Take 1 pack of the test food after breakfast, lunch, and dinner. *If you forget to take t
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese females 2. Subjects who defecate two to five times per week 3. Subjects who are judged as eligible to participate in the study by the principal investigator 4. Subjects who have relatively high CAS score in the Japanese version of CAS-MT at screening and examination before consuming
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. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", food/beverage including lactic acid bacteria, or other functional food/beverage in daily 4. Currently taking medicines (include herbal medicines) and supplements 5. Subjects who are allergic to medicines and/or the test food related products 6. Subjects who are allergic to latex 7. Subjects who are pregnant, breast-feeding, and plan to become a pregnant 8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 9. Subjects who are judged as ineligible to participate in the study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The Japanese version of Constipation Assessment Scale MT version (CAS-MT) * Assess at screening and examination before consuming, and at 1, 2, 3, and 4 weeks after consuming | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Bacterial flora analysis (Terminal Restriction Fragment Length Polymorphism; T-RFLP) 2. Subjective symptoms a. Bowel movement diary b. Bristol scale *1 Assess at 0 and 4 weeks after consuming *2 Record the diary from a week before consuming to the day before 4 weeks after consuming | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed