Effects of Soy on Estrogens in Breast Fluid and Urine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Effect of two daily servings of soy on estrogen levels in nipple aspirate fluid (NAF) and serum
研究概览
简要总结
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. Eating a diet high in isoflavones, compounds found in soy foods, may keep cancer from forming.
PURPOSE: This randomized phase III trial is studying the effects of dietary soy on estrogens in breast fluid, blood, and urine samples from healthy women.
详细描述
OBJECTIVES:
- Examine the effects of two daily servings of soy on estrogen levels in nipple aspirate fluid (NAF) and serum.
- Investigate cytologic patterns of epithelial breast cells obtained from NAF as a measure of proliferation in relation to soy intake.
- Explore the effect of two daily servings of soy on cytochrome alterations of estrogen metabolism as expressed in the formation of urinary 2-, 16α-, and 4-hydroxy estrogen metabolites.
- Compare estrogen levels in NAF and serum measured at the same time during the luteal phase.
OUTLINE: This is a multicenter study. Participants are randomized to 1 of 2 intervention arms.
- Arm I: Participants partake in a high soy diet consisting of 2 daily soy servings (approximately 50mg isoflavones). The choice of soy foods will include ½ cup of tofu, ¾ cup of soy milk, or ¼ cup of soy nuts. Replacement of currently consumed foods with soy foods will be encouraged.
- Arm II: Participants will be asked to keep their soy intake below 3 servings per week. The participants will also receive general nutrition counseling.
In both arms, intervention continues for 6 months. After 6 months, participants undergo a 1-month washout period and then cross-over to the other intervention arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Prevention
入排标准
- 年龄范围
- 30 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •DISEASE CHARACTERISTICS:
- •Healthy participant
- •No diagnosis of cancer
- •PATIENT CHARACTERISTICS:
- •Premenopausal
- •Regular menstrual cycles
- •PRIOR CONCURRENT THERAPY:
- •Not taking birth control pills or other hormones
排除标准
- 未提供
结局指标
主要结局
Effect of two daily servings of soy on estrogen levels in nipple aspirate fluid (NAF) and serum
Cytologic patterns of epithelial breast cells obtained from NAF
Effect of two daily servings of soy on cytochrome alterations of estrogen metabolism as expressed in the formation of urinary 2-, 16α-, and 4-hydroxy estrogen metabolites
Comparison of estrogen levels in NAF and serum measured at the same time during luteal phase
次要结局
未报告次要终点