Clinical Trial: Pilot Study:Role of Dietary Fiber in PCOS Anovulation
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Pilot Study: Role of Dietary Fiber in PCOS Anovulation
Brief Summary: The purpose of this study is to determine whether 6 months of fiber supplementation will improve ovulation in women with polycystic ovary syndrome (PCOS).
Detailed Summary: 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.
Sponsor: Virginia Commonwealth University
Current Primary Outcome: 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. [ Time Frame: 10 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Quantify Enrollment Strategies, Retention, Compliance, Participant Characteristics, and Data Collection Challenges. [ Time Frame: 10 months ]
Original Secondary Outcome: Same as current
Information By: Virginia Commonwealth University
Dates:
Date Received: June 20, 2008
Date Started: February 2008
Date Completion:
Last Updated: June 27, 2014
Last Verified: June 2014