Estrogenicity Of Soy Formula

大豆配方奶粉的雌激素作用

• 批准号: 6672911
• 负责人: WALTER ROGAN
• 金额: --
• 依托单位: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6672911
• 关键词: child physical development; clinical trials; developmental nutrition; dietary supplements; genistein; hormone regulation /control mechanism; human subject; human therapy evaluation; infant human (0-1 year); nutrition related tag; patient oriented research; pediatrics; phytoestrogens; soybeans

Background: Genistein and daidzein are estrogenic isoflavones found in soybeans. Circulating isoflavones in infants fed soy formula are at serum concentrations 3 or 4 orders of magnitude higher than estradiol, so that even if they are weak and readily excreted, there is so much that they should be active. Clinical trial data show increases in cholesterol synthesis consistent with an estrogen effect in infants fed soy formula vs. human milk or cow milk formula, and lowered response to polio vaccination, which might or might not be an estrogen effect. Anatomic, sonographic, and other biochemical evidence of estrogen exposure has not been looked for in infants fed soy. Plausible effects include 1) anatomic expression of estrogen activity: breast buds, labial size, vulval anatomy, scrotal rugae, and, by ultrasound, small ovarian cysts and possibly prostate volume and 2) biochemical evidence of activity: decrease in gonadotropins, decrease in estrone/estradiol synthesis. Whether such widely used products do or do not have clinically detectable estrogenic activity in infants, the group with the highest exposure per kilo, is important clinically and from a public health viewpoint. Aims: We are beginning a clinical trial in which we randomly assign and then observe infants on soy formula with and without soy estrogens to see if their exposure to soy estrogen prolongs anatomical and biochemical evidence of estrogen exposure and response. The time course of these findings in infants is not well characterized, and detailed planning of the trial will require a substantial amount of pilot work.Plausible effects include 1) anatomic expression of estrogen activity: breast buds, labial size, vulval anatomy, scrotal rugae, and, by ultrasound, small ovarian cysts and possibly prostate volume and 2) biochemical evidence of activity: decrease in gonadotropins, decrease in estrone/estradiol synthesis. Pilot studies will begin in Summer, 2003 Accomplishments: This project is in the planning stage. We have reviewed the literature, contructed a preliminary protocol, completed external review, and had a planning meeting with outside experts. Clinical field site awards were made in summer, 2002, and planning meetings hels starting in July, 2002. Phytoestrogen analyses will be done by FDA and CDC. Hormone analysis will be done by NICHD, and data handling and analysis will be directed at NIEHS.

背景： 染料木素和大豆苷元是在大豆中发现的雌激素异黄酮类化合物。在喂食大豆配方奶粉的婴儿中，循环中的异黄酮血浓度比雌二醇高3到4个数量级，所以即使它们很弱，很容易排泄，也有如此多的异黄酮，它们应该是活跃的。临床试验数据显示，与人奶或牛奶配方奶粉相比，服用大豆配方奶粉的婴儿胆固醇合成增加，与雌激素效应一致，对脊髓灰质炎疫苗的反应降低，这可能是也可能不是雌激素效应。在喂食大豆的婴儿中，还没有找到雌激素暴露的解剖学、超声和其他生化证据。可能的影响包括1)雌激素活性的解剖学表达：乳房芽、唇部大小、外阴解剖、阴囊皱纹，以及超声检查显示的小卵巢囊肿和可能的前列腺体积；2)活性的生化证据：促性腺激素减少，雌酮/雌二醇合成减少。无论这种广泛使用的产品在婴儿中是否具有临床可检测到的雌激素活性，每公斤暴露最高的一组，从临床和公共卫生的角度来看都是重要的。 目标： 我们正在开始一项临床试验，在这项试验中，我们随机分配并观察服用大豆配方奶粉的婴儿是否使用大豆雌激素，以确定他们接触大豆雌激素是否延长了雌激素暴露和反应的解剖和生化证据。这些发现在婴儿身上的时间进程还没有很好的描述，详细的试验计划将需要大量的试点工作。可能的效果包括1)雌激素活性的解剖表达：乳房芽、嘴唇大小、外阴解剖、阴囊皱褶，以及通过超声波检查，小的卵巢囊肿和可能的前列腺体积；2)活性的生化证据：促性腺激素减少，雌酮/雌二醇合成减少。初步研究将于2003年夏季开始 成就： 这个项目正在规划阶段。我们回顾了文献，构建了初步方案，完成了外部审查，并与外部专家举行了规划会议。临床现场奖在2002年夏天颁发，规划会议从2002年7月开始。植物雌激素分析将由FDA和CDC进行。激素分析将由NICHD进行，数据处理和分析将直接在NIEHS进行。