SOY AND LIPOPROTEINS IN POSTMENOPAUSAL WOMEN

绝经后女性的大豆和脂蛋白

• 批准号: 7378801
• 负责人: JERILYN K ALLEN
• 金额: $ 0.01万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378801
• 关键词: SOY; LIPOPROTEINS; POSTMENOPAUSAL; WOMEN

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.

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。心血管疾病(CVD)仍然是绝经后妇女死亡和残疾的主要原因。更年期会改变血脂和脂蛋白，从而产生更易致动脉粥样硬化的脂类，这可能会显著增加女性一生中罹患心血管疾病的风险。临床试验表明，含有异黄酮类的大豆蛋白(大豆)对血脂和脂蛋白有有益作用；然而，这些研究包括少量绝经后妇女，几乎没有一项研究包括足够多的非裔美国妇女。此外，目前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的影响的公开数据。因此，这项研究的主要目的是确定大豆对非裔美国人和白人绝经后妇女样本中血脂、脂蛋白和脂蛋白亚类的影响，这些妇女的低密度脂蛋白(LDL)胆固醇升高可能会增加她们患心血管疾病的终身风险，但在目前的指导方针下不符合明确的药物治疗条件。第二个目标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/民族在生活质量、可接受性、对大豆补充剂的依从性和脂蛋白反应方面的差异。建议的研究是一项双盲、安慰剂对照、平行组、随机临床试验。总共160名健康的绝经后妇女(50%是非洲裔美国人)的低密度脂蛋白胆固醇在130毫克/升到190毫克/升之间。在NCEP Step 1 Deit的预随机化磨合期之后，妇女将被随机接受3个月的含有异黄酮类或酪蛋白的膳食补充剂。据推测，与安慰剂相比，补充大豆将大大降低低密度脂蛋白胆固醇、低密度脂蛋白颗粒浓度和致密低密度脂蛋白颗粒的流行，并改善更年期生活质量，这些效果在非裔美国人和白人中将是可比的。这将是第一项确定天然植物产品是否可以改善已知和新的血脂风险因素的不利变化的研究，这些因素是非洲裔美国人和白人女性更年期的结果。这项研究中探索的独特的过渡性结果将大大增加关于大豆影响的有限知识。对这种替代激素替代疗法(HRT)的营养替代疗法的评估可能会对血脂风险因素和更年期症状提供有益的效果，但不会对甘油三酯、乳房和子宫以及与HRT相关的血栓事件产生不利影响，这可能对绝经后妇女的公共卫生产生重大影响。