Healthy male/female adults
Conditions
Interventions
Duration: 12 weeks Test material: Soft capsule containing 20 mg of paprika extract per capsule Dose: five capsules per day Administration: Take the capsule with water or warm water after breakfast
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male/female subjects ranging in age from 20 to 59, at the moment of giving informed consent to participate in this trial. 2. Healthy subjects ranging in BMI from 18.5 to no more than 30. 3. Subjects ranging in ALT from 31 to no more than 51, at the moment of giving informed consent to participate in this trial. 4. Subjects who can give informed consent to take part in this trial after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of adverse events and side effects | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. ALT value 2. Physical measurement 3. Physiological test 4. Hematological test 5. Blood biochemical test, excluding ALT 6. General urine test | — |
Countries
Japan
Contacts
Public ContactMitsuhiro FUJIMOTO
CPCC Company Limited Planning & Sales Department
Outcome results
None listed