Healthy adults
Conditions
Interventions
Period: 12 weeks Test food: "
Dose: Drink 1 bottle of "
, three times a day Usage: Drink 1 bottle of "
with the meal (morning, lunch, and dinner)
Period: 12 weeks Test food: water (placebo) Dose: Drink 1 bottle of water, once a day Usage: intake at optional timing
Sponsors
ORTHOMEDICO, Inc.
Seishin-kai Medical Association Inc, Takara Medical Clinic.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adults 2. The person who defecate three to five times per week
Exclusion criteria
Exclusion criteria: 1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Currently taking medicines (including Chinese medicines), herbal medicines 4. Usually taking Food for Specified Health Uses (FOSHU), Functional display food, yogurt or lactic acid bacteria beverage, which are related with intestinal regulation. 5. Allergic to medicines or foods related to the test food of this trial 6. Usually taking supplements or nutrient function foods in daily 7. Pregnant, lactating, or planning to get pregnant during the trial period 8. Enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial 9. Judged unsuitable for participating in this trial by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intestinal bacterial flora (0 weeks & 12 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Measure pH of stool (0 weeks & 12 weeks) High sensitivity CRP (0 weeks & 12 weeks) The Japanese Version of the Constipation Assessment Scale MT version (0 weeks & 12 weeks) | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO, Inc. R&D Department
Outcome results
None listed