CLINICAL TRIAL: THE CARDIOVASCULAR EFFECTS OF PINE BARK EXTRACT

点击翻译按钮获取中文摘要

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.