The verification study for safety evaluation of excessive the test beverage ingestion in humans: a randomized, double-blind, placebo-controlled, parallel study
- Conditions
- Healthy Japanese adult people
- Registration Number
- JPRN-UMIN000032455
- 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, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 3. Subjects who have a medical history of calculus 4. Subjects who are under the treatment of osteoporosis 5. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 6. Currently taking medicines (include herbal medicines) and supplements 7. Subjects who take fortified food/beverage with calcium in daily 8. Subjects who are allergic to medicines and/or the test beverage related products 9. Subjects who was on medication for hay fever for the last 3 years 10. Subjects who are pregnant, lactation, and planning to become pregnant 11. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 12. 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 4. Subjective symptoms (the Likert scale) * Assess at screening and examination before consuming, at 2 and 4 weeks after ingestion, and follow-up period for 2 weeks
- Secondary Outcome Measures
Name Time Method