LOW FAT HIGH FIBER SOY RICH DIET IN PREMENOPAUSAL WOMEN

目的：对低总脂肪饮食(20%)的坚持和生物反应 富含水果、蔬菜、全谷物和纤维(LFHF饮食) 将在健康、自由生活的绝经前妇女身上进行测量。膳食 总脂肪酸、抗氧化剂和 植物雌激素将用于量化依从性和生物反应 在组内和组间。大豆对这些指标的补充作用 这些参数超出了仅使用LFHF饮食观察到的参数，并添加到 将进一步评估通常的饮食。荷尔蒙反应与 随着时间的推移，将对不同组之间的潜在乳腺癌风险进行比较。 背景/意义：主要假设是坚持 推荐的降低乳腺癌风险的饮食模式是可行的 并可通过主观和客观/生物测量进行量化。 在有效之前，饮食依从性的文件是必不可少的 对代谢反应的解释可以用公式表示。一秒钟 假说解决了关于潜在保护性的越来越多的证据 富含大豆异黄酮、染料木素和大豆素。上一首 饮食干预预防乳腺癌的研究有 集中在绝经后妇女身上。针对年轻女性的研究很少。 并具有样本量小、不可泛化的控制条件、缺乏 数据计时到月经周期、有限的饮食评估和/或关注 不考虑总膳食的单一常量或微量营养素 图案。通过主观方法和 生物学措施，进一步研究荷尔蒙对饮食和 对乳腺癌风险的影响可以通过更大的 自信。通过一项随机、安慰剂对照的LFHF饮食试验 在有和没有大豆补充剂的情况下，一大群人的生物反应 绝经前妇女的健康状况可以按顺序和长期进行测量。 方法：220例绝经前妇女(年龄30~45岁，非肥胖，非低血压) 脂肪饮食，定期)将被随机分配到两种常见饮食中的一种 或LFHF饮食，并将提供饮食、生化和激素跟踪 基线(B)、4个月(4个月)和12个月(12个月)。在12个月，两者都是 干预组(IG)和常规饮食组(UG)随机 分配大豆补充剂(40毫克染料木素)或安慰剂 最初的饮食分配额外四个月或总共16个月 月份。主要结果衡量标准包括三次24小时召回(24小时)， 人体测量(安东诺)、尿植物雌激素、血清总 在B、4个月、12个月和16个月采集脂肪酸和血浆类胡萝卜素 月经日记和用于激素分析的血液样本 (请参阅本IRPG中关于激素反应的详细建议)。 额外的血液和尿液样本将被储存起来，以供进一步分析 微量营养素、脂脂蛋白和其他可能伴随的反应 坚持LFHF-大豆强化饮食，特别是与月经有关的饮食 周期持续时间。

Purpose: Adherence and biologic response to a diet low in total fat (<20% kcal) and high in fruit, vegetables, whole grains and fiber (LFHF Diet) will be measured in healthy, free-living premenopausal women. Dietary assessment and biochemical measures of total fatty acids, antioxidants and phytoestrogens will be used to quantify adherence and biologic response within and between groups. The supplemental effect of soy on these parameters beyond those observed with the LFHF diet alone and added to the usual diet will further be evaluated. Hormonal response relevant to potential breast cancer risk will be compared between groups over time. Background/Significance: The primary hypothesis is that adherence to a dietary pattern recommended for reduced risk of breast cancer is feasible and quantifiable via subjective and objective/biologic measures. Documentation of dietary adherence is essential before valid interpretation of metabolic responses can be formulated. A second hypothesis addresses the growing evidence regarding a potential protective benefit from rich in soy isoflavones, genistein and daidzen. Previous studies of dietary intervention for prevention of breast cancer have concentrated on postmenopausal women. Studies among younger women are few and have small sample sizes, non-generalizable controlled conditions, lack of data timed to menstrual cycles, limited dietary assessment and/or focus on single-macro- or micronutrient without considering the total dietary pattern. By quantifying adherence through both subjective methods and biologic measures, further investigation of hormonal responses to diet and implications for breast cancer risk can be achieved with greater confidence. Through a randomized, placebo controlled trial of LFHF diet with and without soy supplement, the biologic responses in a large group of premenopausal women can be measured sequentially and long term. Methods: 220 premenopausal women (aged 30-45, non-obese, not following low fat diet, regular periods) will be randomly assigned to either usual diet or LFHF diet and will provide dietary, biochemical and hormonal follow-up at baseline (B), 4 (4 mos) and 12 months (12 mos). At 12 mos, both Intervention Group (IG) and Usual Diet Group (UG) will be randomly assigned a soy supplement (40 mg genistein) or placebo within their initial dietary assignment for an additional four months or a total of 16 months. Primary outcome measures include three 24-hour recalls (24 HR), anthropometric measures (ANTHRO), urinary phytoestrogens, serum total fatty acids and plasma carotenoids collected at B, 4 mos, 12 mos and 16 mos as well as menstrual diaries and blood samples for hormone analyses (please see detailed proposal on hormonal responses in this IRPG). Additional blood and urine samples will be banked for further analyses of micronutrients, lipid-lipoproteins and other responses that may accompany adherence to the LFHF-soy enhanced diet especially related to menstrual cycle duration.