Bioavailability of three different Resveratrol products in healthy subjects – a randomized, double-blind three-way cross-over study

Wacker Chemie AG0 个研究点目标入组 15 人开始时间: 2020年5月20日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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.;

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