Bioavailability of three different Resveratrol products in healthy subjects – a randomized, double-blind three-way cross-over study
- Conditions
- Resveratrol Bioavailability
- Registration Number
- DRKS00021683
- Lead Sponsor
- Wacker Chemie AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 15
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;
- 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.;
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measurement of total resveratrol in plasma;<br>Primary endpoint: Comparison of AUC between the study products ; <br>Secondary endpoints: Comparison of Cmax and Tmax between the study products.<br>Time points: 0,5h, 0,75h, 1h, 1,25h, 1,5h, 2h, 3h, 4h, 7h and 10h.
- Secondary Outcome Measures
Name Time Method Measurement of:<br>Plasma free resveratrol; <br>Plasma resveratrol-sulfate; Plasma resveratrol-glucuronide