PILOT STUDY: ROLE OF DIETARY FIBER IN PCOS ANOVULATION

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 该方案假设6个月的纤维补充剂将通过独立于体重减轻而改善胰岛素敏感性来改善多囊卵巢综合征妇女的排卵。在这项先导性研究中，我们将确定在患有多囊卵巢综合征的女性中进行一项更大规模的双盲随机试验来检验这一假设的可行性。因此，我们将对15名年龄在18至45岁(体重指数？45公斤/平方米)的多囊卵巢综合征患者进行为期10个月的评估，首先是4个月的无干预观察期，以建立基线排卵率，然后是6个月的干预期，以确定在她们通常的体重维持饮食中添加多达22克/天的纤维补充剂对排卵的影响(假设基线膳食摄入量为6-14克/天，达到28-36克/天)。补充纤维，而不是改变膳食纤维摄入量，可以可行地转化为临床实践。 具体目标：a)在基线和补充纤维6个月后产生关于结果测量范围的初步数据，包括：1)排卵率，通过尿孕二醇-3-葡萄糖醛酸脂测量；2)胰岛素敏感性，通过频繁采样的静脉葡萄糖耐量试验(FSIVGTT)测量；3)循环雄激素、雌二醇、性激素结合球蛋白和黄体生成素的浓度；以及4)饱腹感，通过视觉模拟标尺测量。B)量化登记策略、保留率、合规性、参与者特征和数据收集挑战。C)确定补充高达22克的液体纤维是否可以耐受，是否足以影响多囊卵巢综合征妇女的排卵率和胰岛素敏感性。D)确定6个月的纤维补充时间是否足以影响多囊卵巢综合征患者的排卵率和胰岛素敏感性。

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. This protocol hypothesizes that 6 months of fiber supplementation will improve ovulation in women with PCOS by improving insulin sensitivity independent of weight loss. In this pilot study, we will determine the feasibility of conducting a larger double-blind, randomized trial in women with PCOS to test this hypothesis. Therefore, we will evaluate 15 women with PCOS between ages 18 to 45 years (body mass index ? 45 kg/m2) over 10 months, starting with a 4-month intervention-free observation period to establish baseline ovulatory rate, followed by a 6-month intervention period to determine the effect on ovulation of adding up to 22 g/day of fiber supplementation to their usual weight-maintenance diets (to achieve 28-36 g fiber/day assuming baseline dietary intake of 6-14 g fiber/day). Fiber supplementation, as opposed to change in dietary fiber intake, could feasibly be translated into clinical practice. The Specific Aims: a) Generate preliminary data on the range of outcome measures at baseline and after 6 months of fiber supplementation in terms of: 1) ovulation rates, as measured by urinary pregnanediol-3-glucuronide measurements; 2) insulin sensitivity, as measured by frequently sampled intravenous glucose tolerance testing (FSIVGTT); 3) concentrations of circulating androgens, estradiol, sex-hormone binding globulin, and luteinizing hormone; and 4) satiety, as measured by a visual analog scale. b) Quantify enrollment strategies, retention, compliance, participant characteristics, and data collection challenges. c) Determine whether a dose of up to 22 grams of liquid fiber supplementation would be tolerable and sufficient to affect ovulation rates and insulin sensitivity in women with PCOS. D) Determine whether 6-month duration of fiber supplementation is sufficient to affect to affect ovulation rates and insulin sensitivity in women with PCOS.