Safety evaluation studies of high dose intake of a food aiming for official recognition as a Food with Function Claims.
Not Applicable
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-UMIN000035164
- Lead Sponsor
- Kochi University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Not provided
Exclusion Criteria
Individuals meeting any of the following conditions will not be selected as study subjects: 1. Pregnant and nursing mothers 2. Individuals taking medication on a routine basis 3. Individuals with persistent diarrhea. 4. Individuals with a fruit allergy 5. Other individuals deemed unsuitable by the principal investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hematologic test Blood biochemistry test Urine analysis Doctor's questions Adverse events Evaluate after 2 weeks and 4 weeks of ingestion.
- Secondary Outcome Measures
Name Time Method