Resveratrol Bioavailability
Conditions
Interventions
Group 1: Resveratrol/gamma-Cyclodextrin formulation, equivalent to 150 mg Resveratrol
Orally, 1 x 6 capsules/day (morning)
Duration of intervention 1 day. One week wash-out.
Group 2: Resveratrol/alpha-Cyclodextrin formulation, equivalent to 150 mg Resveratrol
Duration of intervention 1 day
Group 3: plant-based Resveratrol extract, equivalent to 150 mg Resveratrol
Duration of intervention 1 day
Sponsors
Wacker Chemie AG
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: - Healthy men and women; - BMI between 18.5 and 30 kg/m²; - Non-smoker; - Age: 18-55 years; - Subject is able and willing to sign the Informed Consent Form prior to screening evaluations;
Exclusion criteria
Exclusion criteria: - Relevant history or presence of any severe medical disorder, potentially interfering with this study; - Known allergy and hypersensitivity to ingredients of the study product or to grapes or wine; - A significant CVD event within last 3 months incl. myocardial infarction, stroke, congestive heart failure; - Significant changes in lifestyle or medication (within last 3 months) or surgical intervention or surgical procedure such as bariatric surgery; - For this study clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening; - Blood donation within 1 month prior to study start or during study; - “Extreme dietary regimes”: vegan lifestyle, weight loss diet with <1200 kcal/day for women and <1800 kcal for men; - Regular intake of drugs or supplements possibly interfering with this study within 2 weeks prior to study start or during the study (e.g. resveratrol or resveratrol analogues, glucocorticoids, etc.); - Chronic intake of substances affecting blood coagulation (e.g. acetylic acid, anticoagulants (e.g. Marcumar), diuretics, thiazides), which in the investigator’s opinion would impact subject safety; - Subjects with history of drug, alcohol or other substance abuse, or other factors limiting their ability to co-operate during the study; - Known pregnancy, breast feeding or intention to become pregnant during the study. A pregnancy test will be conducted during screening and visits 1 - 3.;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of total resveratrol in plasma; Primary endpoint: Comparison of AUC between the study products ; Secondary endpoints: Comparison of Cmax and Tmax between the study products. Time points: 0,5h, 0,75h, 1h, 1,25h, 1,5h, 2h, 3h, 4h, 7h and 10h. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measurement of: Plasma free resveratrol; Plasma resveratrol-sulfate; Plasma resveratrol-glucuronide | — |
Countries
Germany
Contacts
Public ContactYvonne Mödinger
BioTeSys GmbH
Outcome results
None listed