EFFECTS OF SOY ISOFLAVONES ON THE PROSTATE, BREAST, AND BONE

大豆异黄酮对前列腺、乳房和骨骼的影响

• 批准号: 7375213
• 负责人: CHRISTOPHER D GARDNER
• 金额: $ 0.22万
• 依托单位: STANFORD 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/7375213
• 关键词: EFFECTS; SOY; ISOFLAVONES; PROSTATE; BREAST

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: Soy foods are high in Isoflavones, one group of "phytoestrogens", which, although non-steroidal, have some estrogen-like properties. Widespread reports of soy's potential benefits have recently led to its increased consumption in the U.S. Purported benefits include protective effects for prostate cancer, breast cancer, and osteoporosis. Evidence for benefit is derived largely from epidemiological associations and laboratory studies with animal or cell models. There are very few human clinical trials. Objective: To study the effects of soy Isoflavone intake on in vitro surrogate cancer markers as well as bone density markers and quality of life parameters in men and women. Broad hypothesis: Isoflavone intake will favorably effect cancer and bone density markers. Design: A randomized, double-blind, cross-over trial design will be used with three populations: i) men with prostate cancer on androgen ablation therapy; ii) postmenopausal women on hormone replacement therapy (HRT); and iii) postmenopausal women not on HRT. Participants will receive an Isoflavone supplement and placebo each for 2-months. Outcomes will be markers of cancers and bone density. Methods: The project's focus will be on the basic science of Isoflavone action. Participants' serum and serum extracts will be incubated with cultured human cell lines (prostate cancer, breast cancer, and osteoblasts) and estrogenic and non-estrogenic mechanisms of action investigated. The human sera data will be complemented by parallel studies of direct addition of crystalline isoflavones (genistein, daidzein, and equol) to the same cultured human cell lines. Participant's serum and urine also will be tested for markers of bone resorption and formation. Quality of life issues will be assessed with questionnaires. Implications: Although many health claims have been made for dietary soy products and their isoflavones, most have not undergone adequate human testing. Under certain conditions, there may be adverse effects. This 5-yr research program seeks to establish the basic mechanisms and pathways of isoflavone actions that underlie their effects on the prostate, the breast and on bone. Results will be relevant to the large segment of the US population suffering from, or at risk of developing, prostate cancer, breast cancer, and osteoporosis and may provide the basis for more definitive clinical trials of soy and/or one or more of its Isoflavone components.

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。背景：大豆食品中含有大量的异黄酮，这是一组“植物雌激素”，虽然非甾体，但具有一些雌激素样特性。关于大豆潜在益处的广泛报道最近导致其在美国的消费量增加，据称益处包括对前列腺癌，乳腺癌和骨质疏松症的保护作用。受益的证据主要来自流行病学协会和动物或细胞模型的实验室研究。人类临床试验很少。 目的：研究大豆异黄酮摄入量对体外替代癌症标志物以及男性和女性骨密度标志物和生活质量参数的影响。 广义假设：异黄酮摄入量将对癌症和骨密度标志物产生有利影响。 设计图：将在三个人群中使用随机、双盲、交叉试验设计：i）接受雄激素消融治疗的前列腺癌男性; ii）接受激素替代治疗（HRT）的绝经后女性; iii）未接受HRT的绝经后女性。参与者将分别接受异黄酮补充剂和安慰剂2个月。结果将是癌症和骨密度的标志物。 方法：该项目的重点将是异黄酮作用的基础科学。将受试者的血清和血清提取物与培养的人细胞系（前列腺癌、乳腺癌和成骨细胞）一起孵育，并研究雌激素和非雌激素的作用机制。人血清数据将通过向相同培养的人细胞系中直接添加结晶异黄酮（染料木黄酮、大豆苷元和雌马酚）的平行研究进行补充。还将检测受试者的血清和尿液中骨吸收和骨形成的标志物。将通过问卷调查评估生活质量问题。 含义：虽然许多健康声称已作出的膳食豆制品和它们的黄酮，大多数没有经过充分的人体测试。在某些情况下，可能会产生不利影响。这项为期5年的研究计划旨在建立对前列腺，乳腺和骨骼影响的基本机制和途径。结果将与美国大部分患有前列腺癌、乳腺癌和骨质疏松症或有患前列腺癌、乳腺癌和骨质疏松症风险的人群相关，并可能为大豆和/或其一种或多种异黄酮成分的更明确的临床试验提供基础。