A Clinical Study for Evaluating the Safety of Long-Term Consumption of Food containing Plant Extract -Open Study
- Conditions
- o
- Registration Number
- JPRN-UMIN000031181
- Lead Sponsor
- Oneness support Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 15
Not provided
(1) Subjects who were diagnosed with serious disease (e.g., diabetes, liver disease, kidney disease, digestive disease, heart disease, respiratory disease and/or peripheral vascular disease). (2) Subjects with abnormal parameters in liver and/or kidney function. (3) Subjects who had a gastrointestinal surgery. (4) Subjects with a disease currently under treatment. (5) Subjects with drug or food allergies. (6) Subjects with anemic. (7) Subjects who play high intensity sports and/or are on a diet. (8) Subjects with irregular life patterns. (9) Subjects who can't stop using functional foods (including Food for Specified Health Uses or Foods with Function Claims) and/or Specified quasi-drugs during the current study periods. (10) Subjects who are under treatment with medications (including OTC or prescribed medication). (11) Subjects who drink excessive alcohol, or who can't stop drinking from one day before each measurement. (12) Subjects who are planning to become pregnant after imformed consent for the current study, pregnant or lactating. (13) Subjects who are participating in other studies or planning to participate during the current study period. (14) 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 Doctor's questions, Physical measurement, Physical examination, Blood test (Hematological test, Blood biochemical test, Serum-immunological test), Urinalysis, Adverse event
- Secondary Outcome Measures
Name Time Method