A Clinical Study for Evaluating the Safety of Excessive Consumption of Food containing Pueraria Flower Extract -Open Study
- Conditions
- o (Subjects under 30 of BMI)
- Registration Number
- JPRN-UMIN000023476
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Not provided
(1) Subjects who are under medical treatment. (2) Subjects who contract or are under treatment for serious diseases (e.g., kidney disease, liver disease, heart disease, respiratory disease, endocrine disease, and/or metabolic disorder). (3) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses and/or Foods with Function Claims) during test periods. (4) Subjects who can't stop drinking from 2 days before each measurement. (5) Subjects who have declared allergic reaction to ingredients of test foods. (6) Subjects who are planning to become pregnant after informed consent for the current study, are pregnant or lactating. (7) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. (8) Subjects who are shiftworker and/or midnight-shift worker. (9) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study. (10) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Biochemical examination, Hematological examination, urine analysis, vital signs
- Secondary Outcome Measures
Name Time Method