A verification study of safety evaluation of the yeast materials long-term ingestion in humans: a randomized, double-blind, placebo-controlled, parallel study.
Not Applicable
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000033507
- Lead Sponsor
- Pharma Foods International Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1)A medical history of malignant tumor, heart failure or myocardial infarction. 2) Currently undergoing treatment for any of the following chronic diseases: atrial fibrillation, cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 3) Subjects who currently taking medications (including herbal medicines) 4) Subjects who are allergic to medications and/or the test food related products. 5) Subjects who are pregnant, breast-feeding, or planning to become pregnant. 6) 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 * Assess these tests at screening and examination before consumption, at 4, 8 and 12 weeks after consumption and 4 weeks after consumption completed.
- Secondary Outcome Measures
Name Time Method