Healthy Japanese subjects
Conditions
Interventions
Duration: 2 weeks Test food: Fermentation product of soy milk with lactic acid bacteria
Duration: 2 weeks Test food: Lactic acid bacteria-free sour clotted soy milk made of soy milk and lactic acid
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who defecate three to five times per week 3. Subjects who are judged as eligible to participate in the study by the physician 4. Subjects whose actual bacterial count of Bifidobacterium is not 0 5. Subjects who have relatively few defecation frequencies in a week before screening (before consumption)
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, irritable bowel syndrome (IBS), or any other chronic diseases 4. Subjects who daily take "Foods for Specified Health Uses", "Foods with Functional Claims", yogurt, lactic fermenting beverage, or other functional food/beverage. Particularly taking food/beverage effective in intestine regulating. 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, breast-feeding, and planning to become pregnant 8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in another clinical trial during trial period 9. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation frequency per week | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Numbers of defecation days per week 2. Amount of defecation per week 3. Shape of stool 4. The Japanese version of Constipation Assessment Scale MT version (CAS-MT) 5. Bristol Stool Scale 6. Occupancy rate of enteric bacteria 7. Actual bacterial count of Bifidobacterium 8. Fecal pH 9. Water content in feces 10. Organic acids in feces 11. Putrefactive products in feces 12. Bile acids in feces 13. Facial skin assessment | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed