CLIN STUDY OF SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RESVERATROL

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a research study testing an experimental substance called resveratrol. We are testing resveratrol for possible benefits including the prevention of cancer. Resveratrol is a naturally occurring compound found in red wine, and is a possible reason why red wine may have health benefits. Before resveratrol can be tested for cancer prevention, we need to find a dose level that can be measured in the blood without causing ill effects. The purpose of this study is to test the safety of resveratrol at different dose levels. We want to find out what effects, good and/or bad it has on humans. We also want to be able measure resveratrol in blood, stool and urine. In this study people will be given resveratrol in doses like those that would be used if it were to be used therapeutically. We want to understand more about how the body processes the resveratrol (i.e. its metabolism). Because there haven't been any clinical studies, the best choice for a therapeutic dose isn't known. Subjects need to be healthy volunteers that meet the inclusion/exclusion criteria for safety, and not be on other chronic medications. Subjects will take resveratrol for 29 days and give blood, urine, and stool samples during that time. They will be asked to avoid foods that are high in resveratrol amounts while they are on study.'