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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 背景资料：与许多亚洲国家一样，消费高水平大豆的人群与消费典型西方饮食的人群相比，卵巢激素水平较低，乳腺癌发病率较低，乳房X线摄影密度也较低。我们的临床研究发现，绝经前妇女的卵巢激素水平最低，而她们的饮食提供了15%的能量，来自含有弱雌激素的豆奶。未观察到不良反应。进一步的问题是，雌激素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乳腺癌的其他可逆风险标志物（如乳腺密度）来实现这一点。 目的：我们计划进行一项随机、双盲、安慰剂对照的2组研究，纳入200名绝经前妇女（N=100/组）至：（1）确定持续暴露于大豆黄酮对血清卵巢激素水平、乳腺密度和骨密度的影响，（2）评估长期暴露于大豆黄酮的潜在不良影响（乳头抽吸物中的上皮细胞增生、闭经和骨密度低）。 研究方法：200名妇女（30至40岁，未避孕，乳房X光检查正常）将被随机分配服用大豆黄酮药片（120 mg总苷元/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和可能的骨密度，而这些乳腺密度的降低与乳腺癌的摄入量有关。