healthy volunteers
Conditions
Interventions
1. placebo at fasting 2. washout ten days 3. rosmarinic acid 250mg at fasting 4. wash out ten days 5. rosmarinic acid 100mg at fasting
1. rosmarinic acid 250mg at fasting 2. washout ten days 3.
Sponsors
Kanazawa University Graduate School of Medical science
Takasaki University of Health and welfare Tokyo University Graduate School of Agricultural and Life Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy volunteer who provided written informed consent.
Exclusion criteria
Exclusion criteria: 1. Consumption of the rosmarinic acid-containing supplement within 15 days before the first rosmarinic acid administration. 2. The dementia including Alzheimer disease. 3. The liver and renal severe dysfunction. 4. The diseases of any malignancy to need continuous medical treatment. 5. Chronic alcoholism, or substance abuse 6. Subjects with a history of severe allergies of polyphenols. 7. Subjects with a history of severe allergies of any drug and food. 8. Participation in any other clinical trial 9. Pregnancy or lactation in women. 10. Any others judged by the investigators to be inappropriate for the subject of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluiate the pharmacokinetic variables including Cmax, T1/2, and AUC after rosmarinic acid (Melissa officinalis extract) intake, at fasting state and postprandial period. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the tolerability and safety including incidence of adverse events, blood tests, vital signs and the incidence rates of completion of rosmarinic acid (Melissa officinalis extract). | — |
Countries
Japan
Contacts
Public ContactKenjiro Ono, Moeko Shinohara
Kanazawa University Graduate School of Medical science Department of Neurology and Neurobiology of Aging
Outcome results
None listed