SOY AND LIPOPROTEINS IN POSTMENOPAUSAL WOMEN

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。心血管疾病（CVD）仍然是绝经后妇女死亡和残疾的主要原因。更年期改变血清脂质和脂蛋白，产生更易致动脉粥样硬化的脂质谱，这可能显著增加女性一生中CVD的生命发展风险。临床试验已经证明了含有大豆蛋白的大豆酮（大豆）对血脂和脂蛋白的有益作用;然而，这些研究包括少数绝经后妇女，几乎没有包括足够的非洲裔美国妇女。此外，还没有关于大豆对绝经后妇女致动脉粥样硬化脂蛋白亚类影响的公开数据。因此，本研究的主要目的是确定大豆对低密度脂蛋白（LDL）胆固醇升高的非裔美国人和白色绝经后妇女的脂质、脂蛋白和脂蛋白亚类的影响，这些妇女可能增加其CVD的终生风险，但根据目前的指南不符合确定的药物治疗条件。次要目的是评估大豆对更年期生活质量的影响，包括更年期症状，并检查种族/民族差异的生活质量，可接受性，坚持，和脂蛋白反应的大豆补充剂。拟定研究是一项双盲、安慰剂对照、平行组、随机临床试验。将入组共计160名LDL胆固醇介于130 mg/DL和190 mg/DL之间的健康绝经后女性（50%为非洲裔美国人）。在NCEP步骤1的预随机化导入期后，女性将随机接受含大豆黄酮或酪蛋白膳食补充剂3个月。据推测，与安慰剂相比，大豆补充剂将导致LDL胆固醇、LDL颗粒浓度和致密LDL颗粒患病率的显著更大降低，以及绝经期生活质量的改善，并且这些效果在非洲裔美国人和白人中相当。这将是第一项研究，以确定是否天然植物产品可以改善已知的和新的脂质危险因素的不利变化，这是更年期的结果，在非洲裔美国人和白色妇女。本研究中探索的独特过渡性结果将大大增加对大豆影响的有限知识。这种营养替代激素替代疗法（HRT）的评价可能对血脂风险因素和绝经期症状产生有益影响，但不会对甘油三酯、乳腺和子宫以及与HRT相关的血栓形成事件产生不良影响，这可能对绝经后妇女产生重大的公共卫生影响。

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. Cardiovascular disease (CVD) remains the leading cause of mortality and disability in post menopausal women. Menopause alters serum lipids and lipoproteins to produce a more atherogenic lipid profile that may contribute significantly to the increased risk for life development of CVD over the lifetime of women. Clinical trials have demonstrated a beneficial effect of soy protein containing isoflavones (soy) on plasma lipids and lipoproteins; however, these studies included small numbers of postmenopausal women and virtually none included sufficient African-American women. In addition, no published data exist on the impact of soy on atherogenic lipoprotein subclasses in postmenopausal women. Therefore, the primary aim of this study is to determine the effects of soy on lipids, lipoproteins, and lipoprotein subclasses in a sample of African-American and white postmenopausal women with low-density lipoprotein (LDL) cholesterol elevations that may increase their lifetime risk for CVD but would not qualify for definitive pharmacotherapy under current guidelines. The secondary aims are to assess the impact of soy on menopausal quality of life, including menopausal symptoms, and to examine racial/ethnic differences in quality of life, acceptability, adherence to, and lipoprotein response to the soy supplementation. The proposed study is a double blind, placebo-controlled, parallel group, randomized clinical trial. A total of 160 healthy post menopausal women (50 % African-American) with LDL cholesterol between 130 mg/DL and 190 mg/DL will be enrolled. Following a pre-randomization run-in period on a NCEP Step 1 deit, women will be randomized to receive soy containing isoflavones or casein dietary supplements for 3 months. It is hypothesized that soy supplementation will result in significantly greater reduction in LDL cholesterol, LDL particle concentration, and prevalence of dense LDL particles and improvement in menopausal quality of life compared with placebo and that these effects will be comparable in African-Americans and Whites. This will be the first study to determine whether a natural plant product can ameliorate the unfavorable changes in known and novel lipid risk factors that are a consequence of menopause in both African-American and white women. The unique transitional outcomes explored in this study will add substantially to the limited body of knowledge on the effects of soy. Evaluation of this nutritional alternative to hormone replacement therapy (HRT) that may provide a beneficial effect on lipid risk factors and menopausal symptoms but would be free of the adverse effects on triglycerides, the breast and uterus, and thrombotic events associated with HRT could have significant public health implications for postmenopausal women.