PILOT STUDY: ROLE OF DIETARY FIBER IN PCOS ANOVULATION

试点研究：膳食纤维在多囊卵巢综合症（PCOS）排卵中的作用

• 批准号: 8166565
• 负责人: PAULINA A ESSAH
• 金额: $ 0.16万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8166565
• 关键词: Affect; Age; Androgens; Anovulation; Body Weight decreased; Body mass index; Characteristics; Computer Retrieval of Information on Scientific Projects Database; Data; Data Collection; Diet; Dietary Fiber; Dietary intake; Dose; Double-Blind Method; Enrollment; Estradiol; Fiber; Funding; Glucuronides; Grant; Institution; Intake; Intervention; Liquid substance; Luteinizing Hormone; Measurement; Measures; Outcome Measure; Ovulation; Participant; Pilot Projects; Pregnanediol; Protocols documentation; Research; Research Personnel; Resources; Role; Sampling; Satiation; Sex Hormone-Binding Globulin; Source; Supplementation; Testing; Translating; United States National Institutes of Health; Visual; Woman; analog; clinical practice; improved; insulin sensitivity; intravenous glucose tolerance test; randomized trial; urinary; weight maintenance

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 该方案假设，6 个月的纤维补充剂将通过提高胰岛素敏感性（与体重减轻无关）来改善 PCOS 女性的排卵。 在这项试点研究中，我们将确定对患有 PCOS 的女性进行更大规模的双盲随机试验来检验这一假设的可行性。 因此，我们将在 10 个月内对 15 名年龄在 18 至 45 岁之间（体重指数≥ 45 kg/m2）的 PCOS 女性进行评估，首先进行 4 个月的无干预观察期，以确定基线排卵率，然后进行 6 个月的干预期，以确定在日常体重维持饮食中添加 22 克/天的纤维补充剂（以达到 28-36 克纤维/天）对排卵的影响。假设 基线膳食摄入量为 6-14 克纤维/天）。与改变膳食纤维摄入量相反，纤维补充可以切实地转化为临床实践。 具体目标： a) 生成基线和补充纤维 6 个月后的结果测量范围的初步数据，包括： 1) 排卵率，通过尿孕二醇-3-葡萄糖醛酸测量来测量； 2) 胰岛素敏感性，通过频繁采样的静脉内葡萄糖耐量试验 (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； 4) 饱腹感，通过视觉模拟量表测量。 b) 量化注册策略、保留率、合规性、参与者特征和数据收集挑战。 c) 确定最多 22 克液体纤维补充剂的剂量是否可以耐受并足以影响 PCOS 女性的排卵率和胰岛素敏感性。 D) 确定 6 个月的纤维补充剂持续时间是否足以影响 PCOS 女性的排卵率和胰岛素敏感性。