The verification study for safety evaluation of excessive the test food ingestion in humans: a randomized, double-blind, placebo-controlled, parallel study
- Conditions
- Healthy Japanese adult people
- Registration Number
- JPRN-UMIN000031218
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Simple measurement of bone mineral density *Perform the test at screening and examination before consuming and at 2, and 4 weeks after ingestion