SOY AND LIPOPROTEINS IN POSTMENOPAUSAL WOMEN

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。心血管疾病（CVD）仍然是绝经后妇女死亡和残疾的主要原因。绝经改变了血清脂质和脂蛋白，从而产生更具有动脉粥样硬化性的脂质谱，这可能会显著增加女性一生中心血管疾病的风险。临床试验已经证明含有异黄酮的大豆蛋白（大豆）对血浆脂质和脂蛋白有益；然而，这些研究只纳入了少数绝经后妇女，几乎没有纳入足够的非裔美国妇女。此外，尚无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人绝经后妇女样本中的脂质、脂蛋白和脂蛋白亚类的影响，这些低密度脂蛋白（LDL）胆固醇升高可能会增加她们一生中患心血管疾病的风险，但在目前的指导方针下不符合最终药物治疗的资格。次要目的是评估大豆对绝经期生活质量的影响，包括更年期症状，并检查种族/民族在生活质量、可接受性、依从性和脂蛋白对大豆补充剂的反应方面的差异。本研究为双盲、安慰剂对照、平行组、随机临床试验。共有160名健康的绝经后妇女（50%是非裔美国人），LDL胆固醇在130毫克/分升到190毫克/分升之间。在NCEP步骤1的预随机化磨合期之后，女性将随机接受含有异黄酮或酪蛋白的大豆膳食补充剂3个月。据推测，与安慰剂相比，大豆补充剂将显著降低低密度脂蛋白胆固醇、低密度脂蛋白颗粒浓度和高密度低密度脂蛋白颗粒的发生率，并改善绝经期生活质量，而且这些效果在非裔美国人和白人中具有可比性。这将是第一个确定天然植物产品是否可以改善非裔美国人和白人妇女绝经后已知和新的脂质危险因素的不利变化的研究。本研究中探索的独特的过渡性结果将大大增加对大豆影响的有限知识体系。这种激素替代疗法（HRT）的营养替代品可能对脂质危险因素和更年期症状有有益影响，但不会对甘油三酯、乳房和子宫以及与HRT相关的血栓形成事件产生不良影响，对绝经后妇女的公共卫生具有重要意义。

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.