Confirmation trial for safety and improvement effects by test-food ingestion on impaired liver function.
- Conditions
- Healthy male/female adults
- Registration Number
- JPRN-UMIN000042678
- Lead Sponsor
- CPCC Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 48
Not provided
1. Subjects with some kind of medical treatment continuously. 2. Subjects who have used the following foods that might affect their test result; health-specific, functional, health foods, etc., with any difficulty in refraining from having those. 3. Pregnant or possibly pregnant women, or lactating ones. 4. Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. 5. Subjects with excessive alcohol intake. 6. Subjects with extremely irregular life rhythms, and subjects with midnight work or irregular shift work. 7. Subjects with previous medical history of drug and/or food allergy. 8. Subjects falling into the habit of smoking. 9. Subjects who are now under the other clinical tests with some kind of medicine/food, or going to take part in those tests within four weeks after the current trial. 10. Subjects who donated over 200 mL of their whole blood and/or blood components within a month to the current trial. 11. Male subjects who donated over 400 mL of their whole blood within the last three months to the current trial. 12. Female subjects who donated over 400 mL of their whole blood within the last four months to the current trial. 13. Male subjects who will be collected over 1200 mL in total of their blood within the last twelve months, after adding the planned sampling blood amounts in this trial. 14. Female subjects who will be collected over 800 mL in total of their blood within the last twelve months, after adding the planned sampling blood amounts in this trial. 15. Others who have been determined as ineligible for participation, according to the principal/sub investigator's opinions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence rate of adverse events and side effects
- Secondary Outcome Measures
Name Time Method 1. ALT value 2. Physical measurement 3. Physiological test 4. Hematological test 5. Blood biochemical test, excluding ALT 6. General urine test