Healthy Japanese adult people
Conditions
Interventions
Duration: 4 weeks Test materials: Tablets containing Bacillus subtilis Dose: 18 tablets per day Administration: Take the test tablets with water multiple times per day. Do not chew tablets. * Dail
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult people 2. Subjects who are judged as eligible to participate in the study by the physician
Exclusion criteria
Exclusion criteria: 1. A medical history of malignant tumor, heart failure or myocardial infarction 2. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, irritable bowel syndrome, osteoporosis, or any other chronic diseases 3. Subjects who daily consume "Foods for Specified Health Uses" or "Foods with Functional Claims" 4. Currently taking medications (include herbal medicines) and supplements *Particularly taking warfarin 5. Subjects who are allergic to medications and/or products related to the study substance *Particularly soybeans, natto allergy 6. Subjects who have lactose intolerance 7. Subjects who are pregnant, lactation, 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 9. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Physical examination 2. Urinalysis 3. Blood test *1-3 Perform the test at screening and examination before consuming and at 2, and 4 weeks after ingestion | — |
Secondary
| Measure | Time frame |
|---|---|
| Simple measurement of bone mineral density *Perform the test at screening and examination before consuming and at 2, and 4 weeks after ingestion | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed