Pilot Study:Role of Dietary Fiber in PCOS Anovulation
The purpose of this study is to determine whether 6 months of fiber supplementation will improve ovulation in women with polycystic ovary syndrome (PCOS).
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study: Role of Dietary Fiber in PCOS Anovulation|
- 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 ] [ Designated as safety issue: No ]
- Quantify enrollment strategies, retention, compliance, participant characteristics, and data collection challenges. [ Time Frame: 10 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
|Experimental: fiber stat||
Liquid fiber supplement, 2 tablespoons twice daily.
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.
|United States, Virginia|
|VCU General Clinical Research Center|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Paulina A Essah, M.D.||Virginia Commonwealth University|