Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Richmond, Virginia 23298


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)


NCT ID:

NCT00703092


Primary Contact:

Principal Investigator
Paulina A Essah, M.D.
Virginia Commonwealth University


Backup Contact:

N/A


Location Contact:

Richmond, Virginia 23298
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.