Pilot Study: Role of Dietary Fiber in PCOS Anovulation
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Generate Preliminary Data on the Range of Outcome Measures at Baseline and After 6 Months of Fiber Supplementation in Terms of: Ovulation Rates, Insulin Sensitivity, Concentrations of Circulating Androgens and Satiety.
研究概览
简要总结
The purpose of this study is to determine whether 6 months of fiber supplementation will improve ovulation in women with polycystic ovary syndrome (PCOS).
详细描述
We hypothesize 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. We will evaluate 15 women over a 10-month period, starting with a 4-month intervention-free observation period to determine the effect on ovulation of adding up to 22g/day of fiber supplementation to their usual weight-maintenance diets (to achieve 28-36 g fiber/day assuming baseline dietary fiber intake, could feasibly be translated into clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with PCOS between the ages of 18-45 years and with a body mass index of less than or equal to 45
- •Less than or equal to 8 periods annually
- •elevated serum free testosterone concentrations
- •normal thyroid function tests and serum prolactin
- •exclusion of late-onset adrenal hyperplasia
- •acceptable health based on interview, medical history,physical examination, and lab tests
- •ability to comply with the requirements of the study
- •ability and willingness to provide signed, witnessed informed consent
排除标准
- •Diabetes mellitus
- •Clinically significant pulmonary,cardiac ,renal,hepatic,neurologic,psychiatric,infectious,and malignant disease
- •high blood pressure
- •current or recent(within 2 months prior to study entry) injection of any drugs known or suspected to affect reproductive function including oral contraceptives,metformin,thiazolidinediones,glucocorticoids, GnRH-agonists, or anti-androgens (spironolactone,flutamide,etc)
- •documented or suspected history of use of recent (within one year) illicit drug abuse or alcoholism
- •ingestion of any investigational drugs within 4 weeks prior to study onset
- •pregnancy or lactation(less than or equal to 6 weeks postpartum)
研究组 & 干预措施
Fiber-Stat
2 tablespoons daily
干预措施: Fiber-Stat (Drug)
结局指标
主要结局
Generate Preliminary Data on the Range of Outcome Measures at Baseline and After 6 Months of Fiber Supplementation in Terms of: Ovulation Rates, Insulin Sensitivity, Concentrations of Circulating Androgens and Satiety.
时间窗: 10 months
次要结局
- Quantify Enrollment Strategies, Retention, Compliance, Participant Characteristics, and Data Collection Challenges.(10 months)