Pilot Study:Role of Dietary Fiber in PCOS Anovulation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study: Role of Dietary Fiber in PCOS Anovulation

Conditions
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PCOS

Intervention / Treatment
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* Drug: Fiber-Stat


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fiber-Stat<br>2 tablespoons daily | Drug: Fiber-Stat<br>* Liquid fiber supplement, 2 tablespoons twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantify Enrollment Strategies, Retention, Compliance, Participant Characteristics, and Data Collection Challenges. |  | 10 months |