Estrogenicity Of Soy Formula

大豆配方奶粉的雌激素作用

• 批准号: 6837539
• 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/6837539
• 关键词: baby food; child physical development; clinical research; developmental nutrition; estradiol; genistein; hormone regulation /control mechanism; human milk; human subject; infant human (0-1 year); longitudinal human study; milk; nutrition related tag; phytoestrogens; soybeans

We are doing pilot studies of the anatomical, ultrasonagraphic, and biochemical responses of newborns to estrogen exposure, in order to plan a clinical study comparing the estrogenic effects of soy formula, which is high in phytoestrogens, with cow milk based formula and human milk. 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. These studies began in Summer, 2003. Genistein and daidzein are estrogenic isoflavones found in soybeans. Although they are about 1/10,000 as potent as estradiol, serum concentrations are up to 4 orders of magnitude higher than estradiol in infants fed soy formula. 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. 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; in addition, it may be a crucial test of the ability of laboratory measures of estrogenicity to predict "endocrine disruption" in humans. We have begun pilot studies to examine the natural history of estrogen responsive physiology in the newborn, and will use the results to develop a longitudinal study of the possible estrogenic effects of soy formula on infants. The two clinical sites began enrolling children in summer, 2003, and will enroll for 6 months. 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.

我们正在对新生儿对雌激素暴露的解剖学、超声检查和生化反应进行初步研究，以便计划一项临床研究，比较富含植物雌激素的大豆配方奶粉与牛奶配方奶粉和人乳的雌激素作用。可能的影响包括 1) 雌激素活性的解剖表达：乳芽、阴唇大小、外阴解剖结构、阴囊皱襞，以及超声显示的小卵巢囊肿和可能的前列腺体积，以及 2) 活性的生化证据：促性腺激素减少、雌酮/雌二醇合成减少。这些研究始于 2003 年夏天。 金雀异黄酮和大豆黄酮是大豆中发现的雌激素异黄酮。尽管它们的效力约为雌二醇的 1/10,000，但在喂养大豆配方奶粉的婴儿中，其血清浓度比雌二醇高出 4 个数量级。临床试验数据显示，与母乳或牛奶配方奶粉喂养的婴儿相比，用大豆配方奶粉喂养的婴儿胆固醇合成增加，这与雌激素效应一致，并且对脊髓灰质炎疫苗接种的反应降低，这可能是也可能不是雌激素效应。尚未在食用大豆的婴儿中寻找雌激素暴露的解剖学、超声检查和其他生化证据。这些广泛使用的产品是否对婴儿（每公斤暴露量最高的群体）具有临床可检测的雌激素活性，在临床上很重要；此外，这可能是对实验室雌激素水平测量预测人类“内分泌紊乱”能力的一项重要测试。我们已经开始进行试点研究，以检查新生儿雌激素反应生理学的自然史，并将利用这些结果开展一项关于大豆配方奶粉对婴儿可能的雌激素影响的纵向研究。 两个临床中心于2003年夏天开始招募儿童，为期6个月。植物雌激素分析将由 FDA 和 CDC 进行。激素分析将由 NICHD 完成，数据处理和分析将由 NIEHS 负责。