CLINICAL TRIAL: MAMMOGRAPHIC DENSITY AND SOY ISOFLAVONES

临床试验：乳房X光密度和大豆异黄酮

• 批准号: 7719179
• 负责人: LEE-JANE W LU
• 金额: $ 49.88万
• 依托单位: UNIVERSITY OF TEXAS MED BR GALVESTON
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7719179
• 关键词: Adverse effects; Affect; Amenorrhea; Asians; Aspirate substance; Bone Density; Chronic; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Contraceptive Agents; Country; Diet; Double-Blind Method; Epithelial Cells; Exposure to; Funding; Grant; Hyperplasia; Institution; Intake; Isoflavones; Mammographic Density; Mammography; Methods; Nipples; Ovarian hormone; Placebo Control; Placebos; Population; Premenopause; Randomized; Rate; Research; Research Personnel; Resources; Risk Marker; Serum; Source; United States National Institutes of Health; Upper arm; Week; Woman; breast density; cancer risk; day; malignant breast neoplasm; maltodextrin; pill; soy; soy protein isolate; treatment duration

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. Background: Populations consuming high levels of soy, as in many Asian countries, have lower levels of ovarian hormones, lower rates of breast cancer, and reduced mammographic density than populations consuming typical Western diets. These observations may in part be explained by our clinical studies that found ovarian hormone levels of premenopausal women to be lowest while they were consuming a diet that provided 15% energy from soymilk containing weakly estrogenic isoflavones. No adverse effects were observed. Further questions are whether isoflavones are the critical components influencing breast cancer risk and whether they do so by affecting other reversible risk markers for breast cancer, such as breast density. Aims: We propose to conduct a randomized, double-blind placebo controlled 2-arm study, with 200 premenopausal women (N=100/arm) to: (1) determine the effects of continuing exposure to isoflavones on serum levels of ovarian hormones and breast density and bone density and (2) assess potential adverse effects of chronic soy isoflavone exposure (hyperplastic epithelial cells in nipple aspirates, amenorrhea and low bone density). Methods: 200 women (30 to 40 years old, not on contraceptive, with normal mammograms) will be randomly allocated to take soy isoflavones in pills (120 mg of total aglycones/day) (treatment) or placebo (maltodextrin 120 mg/day) (placebo) 5 days per week for 2 years We predict that the soy diet will reduce breast density and possibly bone density, and that these reductions in breast density will correlate with isoflavone intakes.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 背景：与食用典型西方饮食的人群相比，食用大量大豆的人群（如许多亚洲国家）的卵巢激素水平较低，乳腺癌发病率较低，乳房 X 光检查密度较低。这些观察结果可能部分地可以通过我们的临床研究来解释，该研究发现绝经前女性的卵巢激素水平最低，而她们的饮食中15%的能量来自含有弱雌激素异黄酮的豆奶。没有观察到不良反应。进一步的问题是异黄酮是否是影响乳腺癌风险的关键成分，以及它们是否通过影响其他乳腺癌可逆风险标志物（例如乳腺密度）来实现这一点。 目的：我们建议对 200 名绝经前妇女（N=100/组）进行一项随机、双盲安慰剂对照 2 组研究，目的是：(1) 确定持续接触异黄酮对卵巢激素和血清水平的影响乳房密度和骨密度；(2) 评估长期暴露于大豆异黄酮的潜在不利影响（乳头抽吸物中的上皮细胞增生、闭经和骨密度低）。 方法：200 名女性（30 至 40 岁，未采取避孕措施，乳房 X 光检查正常）将被随机分配服用大豆异黄酮药片（总苷元 120 毫克/天）（治疗）或安慰剂（麦芽糖糊精 120 毫克/天） （安慰剂）每周 5 天，持续 2 年 我们预测，大豆饮食将降低乳房密度，并可能降低骨密度，并且乳房密度的这些降低将与异黄酮摄入量相关。