NCT00703092

Pilot Study:Role of Dietary Fiber in PCOS Anovulation

Pilot Study: Role of Dietary Fiber in PCOS Anovulation

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• PCOS

Interventions

Type	Name	Description
DRUG	Fiber-Stat	Liquid fiber supplement, 2 tablespoons twice daily.

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2008-06-23
• Last updated: 2017-10-09
• Results posted: 2014-06-30

Locations

1 site across 1 country: United States