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Pilot Study:Role of Dietary Fiber in PCOS Anovulation - NCT00703092-23298(Clinical Trial 228510)



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City:  Richmond
State:  
VA
Zip Code: 23298
Conditions: PCOS
Purpose: 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 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.
Criteria: Inclusion Criteria: - 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 Exclusion Criteria: - 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)
Study is available at: VCU General Clinical Research Center
Richmond, VA 23298
United States

Primary Contact:
Manar T Nazmy
Email: mtnazmy@vcu.edu
Phone: 804-827-0171

Secondary Contact:
Manar T Nazmy
Email: mtnazmy@vcu.edu
Phone: 804-827-0171
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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