CLIN STUDY OF SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RESVERATROL

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项测试一种名为白藜芦醇的实验物质的研究。我们正在测试白藜芦醇可能的益处，包括预防癌症。白藜芦醇是一种天然存在于红葡萄酒中的化合物，这可能是红酒对健康有益的一个原因。在白藜芦醇可以被测试用于癌症预防之前，我们需要找到一个可以在血液中测量而不会造成不良影响的剂量水平。本研究的目的是测试不同剂量水平白藜芦醇的安全性。我们想找出它对人类有什么影响，好的和坏的。我们还希望能够检测血液、粪便和尿液中的白藜芦醇。在这项研究中，白藜芦醇的剂量与治疗用白藜芦醇的剂量相同。我们想更多地了解身体是如何处理白藜芦醇的(即它的新陈代谢)。由于还没有任何临床研究，治疗剂量的最佳选择尚不清楚。受试者需要是符合安全纳入/排除标准的健康志愿者，并且没有服用其他慢性药物。受试者将服用白藜芦醇29天，并在此期间提供血液、尿液和粪便样本。他们将被要求在学习期间避免吃白藜芦醇含量高的食物。

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.'