CVD RISK & HEALTH IN POSTMENOPAUSAL PHYTOESTROGEN USERS

描述：（改编自研究者摘要）在美国， 心脏病是绝经后妇女死亡的主要原因。 雌激素替代疗法对心脏病危险因素有益， 以及骨密度。 然而，很大一部分绝经后妇女 妇女不遵守治疗方案。 植物雌激素是 植物和豆制品中天然存在的化合物， 雌激素的作用，并可能代表一种替代治疗的 预防绝经后妇女的心脏病和骨质疏松症。 然而，很少有干预试验研究了它在多大程度上 可能改善心脏病风险因素，骨密度和骨质量， 生活在绝经后妇女通过使用膳食补充剂 植物雌激素。 所提出的随机、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（染料木黄酮）与安慰剂对心脏病危险因素的影响， 45-74岁绝经后妇女的骨密度和心理社会结果。 大约300名妇女将接受筛选，以招募200名（100 100例安慰剂组），每人随访一年。 数据将 在筛选和基线访视、1个月和3个月随访时收集 电话以及6个月和12个月的随访门诊访视。 措施 高密度脂蛋白和其他心脏病风险因素，髋关节和脊柱骨密度，以及 将获得抑郁、生活满意度和幸福质量。 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进行， 潜在混杂协变量。 预计接受治疗的妇女 植物雌激素会有更高的高密度脂蛋白和骨密度， 心理社会结果。 也可以预期，使用植物雌激素的女性 将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、空腹和绝经后激发血糖， 胰岛素和脂肪分布。 考虑到女性在怀孕后的三分之一的生命 更年期，研究人员指出，重要的是要知道如何 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，通过定义植物雌激素的影响， 研究将有助于了解如何预防心血管疾病 疾病和骨质疏松症的绝经后妇女，从而改善他们的 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.