CLINICAL TRIAL: PHASE I PREVENTION TRIAL OF ACTIVIN TM GRAPE SEED EXTRACT AS AN

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。 芳香酶抑制剂治疗的对侧乳腺癌(BC)减少表明，它们可能对预防BC有效。对于喜欢膳食补充剂而不是标准药物的女性来说，营养食品是很受欢迎的替代品。我们小组展示了一种以前未知的葡萄籽提取物(GSE)的抗芳香酶作用。我们建议将其转化为人类BC化学预防试验。 目标： 1.为了确定GSE是否显著抑制患BC风险增加的绝经后妇女的循环雌激素， 2.为收集初步剂量信息， 3.确定生物利用度，以及 4.评估人体的安全性和耐受性。 方法：在为期2周的安慰剂控制期之后，24名受试者将接受为期12周的4个剂量水平的GSE治疗。每隔一段时间抽血进行血清雌激素、原花青素浓度和芳香酶抑制试验。GSE前后将检查骨代谢和肾上腺抑制的标志物，并跟踪症状记录。

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. Decreased contralateral breast cancer (BC) seen with aromatase inhibitor therapy suggests they may be effective for BC prevention. Nutriceuticals are popular alternatives for women who prefer dietary supplements over standard pharmaceuticals. Our group demonstrated a previously unknown anti-aromatase effect with grape-seed extract (GSE). We propose translation to a human BC chemoprevention trial. Objectives: 1. to determine whether GSE significantly suppresses circulating estrogens in postmenopausal women at increased BC risk, 2. to gather preliminary dose information, 3. to determine bioavailability, and 4. to evaluate safety and tolerability in humans. Methods: Twenty-four subjects will be treated with GSE at four dose levels for a 12-week period, following a 2-week placebo control period. Blood will be drawn at scheduled intervals for serum estrogen, procyanidin concentration, and aromatase inhibition assays. Markers of bone metabolism and adrenal suppression will be checked pre and post GSE, and symptom logs will be followed.