CVD RISK & HEALTH IN POSTMENOPAUSAL PHYTOESTROGEN USERS

描述：(改编自《调查者摘要》)在美国， 心脏病是绝经后妇女的主要死因。 雌激素替代疗法对心脏病危险因素有好处，因为 对于骨密度也是如此。然而，有很大比例的绝经后妇女 女性不遵守治疗方案。植物雌激素是 在植物和豆制品中发现的天然化合物，具有 雌激素效应，并可能是一种替代治疗 预防绝经后妇女的心脏病和骨质疏松症。 然而，很少有干预试验检验它的程度 有可能改善心脏病的危险因素、骨密度和 通过使用膳食补充剂改善绝经后妇女的生活 植物雌激素。 建议的随机、双盲、安慰剂对照研究设计为 确定使用膳食补充剂的可接受性和益处 植物雌激素(金雀异黄素)与安慰剂在心脏病风险因素上的比较， 45-74岁绝经后妇女的骨密度和心理社会结局。 将对大约300名妇女进行筛查，以招收200(100)人 治疗，100名安慰剂)，每个人将被跟踪一年。数据将 在筛查和基线访问、1个月和3个月的随访时收集 电话，以及6个月和12个月的后续诊所访问。衡量标准 高密度脂蛋白和其他心脏病危险因素，臀部和脊柱骨密度，以及 抑郁、生活满意度和幸福感质量将会得到提高。 治疗组和安慰剂组的横断面和纵向比较 将在调整和分层之前和之后执行 潜在的混杂协变量。预计接受治疗的女性 植物雌激素将具有更高的高密度脂蛋白和骨密度，更有利于 心理社会后果。人们还预计，使用植物雌激素的女性 会有更有利的总胆固醇、低密度脂蛋白、甘油三酯、脂蛋白(A)、 纤维蛋白原、血压、空腹和绝经后挑战血糖和 胰岛素和脂肪分布。 考虑到女性可以预期在死后生活的三分之一 更年期，研究人员指出，重要的是知道如何 植物雌激素可能会改变心脏病的危险因素和骨密度。他们 进一步指出，通过定义使用植物雌激素的影响，这一点 研究将有助于理解如何预防心血管疾病 绝经后妇女的疾病和骨质疏松症，从而改善其 生活质量。

DESCRIPTION: (Adapted from Investigator's Abstract) In the United States, heart disease is the leading cause of death in postmenopausal women. Estrogen replacement therapy is beneficial for heart disease risk factors as well as for bone density. However, a large proportion of postmenopausal women are not compliant with therapeutic regimens. Phytoestrogens are naturally occurring compounds found in plants and soy products that have estrogenic effects, and may represent an alternative treatment for the prevention of heart disease and osteoporosis in postmenopausal women. However, few intervention trials have examined the extent to which it is possible to improve heart disease risk factors, bone density, and quality of life in postmenopausal women through use of a dietary supplement of Phytoestrogen. The proposed randomized, double-blind, placebo controlled study is designed to determine the acceptability and benefits of use of a dietary supplement of Phytoestrogen (genistein) versus placebo on heart disease risk factors, bone density and psychosocial outcomes in postmenopausal women aged 45-74. Approximately 300 women will be screened in order to enroll 200 (100 treatment, 100 placebo) who will each be followed for one year. Data will be collected at screening and baseline visits, 1 and 3-month follow-up telephone calls, and 6- and 12-month follow-up clinic visits. Measures of HDL, and other heart disease risk factors, hip and spine bone density, and depression, life satisfaction, and quality of well-being will be obtained. Cross-sectional and longitudinal comparisons of treatment and placebo groups will be performed before and after adjustment and stratification for potentially confounding covariates. It is expected that women treated with Phytoestrogen will have higher HDL and bone density, and more favorable psychosocial outcomes. It is also expected that women using Phytoestrogen will have more favorable total cholesterol, LDL, triglycerides, Lp(a), fibrinogen, blood pressure, fasting and postmenopausal challenge glucose and insulin, and fat distribution. Given that women can expect to live one-third of their lives after menopause, the investigators point out that it is important to know how Phytoestrogen may modify heart disease risk factors and bone density. They further state that by defining the influence Phytoestrogen use has, this study would contribute to understanding of how to prevent cardiovascular disease and osteoporosis in postmenopausal women and thereby improve their quality of life.