CLINICAL TRIAL: THE CARDIOVASCULAR EFFECTS OF PINE BARK EXTRACT

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 松树皮提取物含有天然存在的低聚原花青素复合物（OPC）。 OPC补充剂在美国流行的草药补充剂中排名第四。初步研究表明，松树皮提取物可能对血压和其他心血管益处有降低作用，包括改善血糖控制、减轻体重、改善血脂、改善外周循环和减弱血小板聚集。 虽然这些研究提供了有希望的信息，但相对较少的研究是如此广泛使用的草药疗法的最佳选择。 我们建议进行一项随机、安慰剂对照、双盲、平行试验，在130名研究参与者中调查黄烷醇（日本东洋新宿）（松树皮提取物）的疗效和安全性。 这些受试者将是由于高血压前期、超重和胰岛素不敏感而具有轻度或中度心血管疾病（CVD）风险升高的个体。 我们的目标是确定（按优先顺序）： 1. 黄烷醇的降血压作用。 2. 黄烷醇改善血糖控制和血浆脂蛋白谱的疗效。 3. 体重、抗氧化能力、抗炎标志物和肝功能试验对黄烷醇的反应变化。 4. 黄烷醇的安全性，作为过去研究的证实。

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. Pine bark extract contains naturally occurring oligomeric proanthocyanidin complexes (OPC). OPC supplements rank the fourth highest among popular herbal supplements in the U.S. Preliminary studies have shown that pine bark extract may have lowering effects on blood pressure and additional cardiovascular benefits including improved glycemic control, reduced body weight, improved lipid profile, improved peripheral circulation, and blunted platelet aggregation. While these studies provide promising information, relative few were as large or as rigorous as optimal for such a widely used herbal therapy. We propose to conduct a randomized, placebo-controlled, double-blind, parallel trial that will investigate the efficacy and safety of Flavangenol (Toyo Shinyaku, Japan), a pine bark extract, among 130 study participants. These participants will be individuals at mildly or moderately elevated risk of cardiovascular disease (CVD) because of prehypertension, excess body weight, and insulin insensitivity. We aim to determine (in order of priority): 1. The efficacy of Flavangenol in lowering blood pressure. 2. The efficacy of Flavangenol in improving glycemic control and plasma lipoprotein profile. 3. Changes in body weight, antioxidative capacity, anti-inflammatory markers and liver function tests in response to Flavangenol. 4. The safety of Flavangenol, as confirmation of past studies.