Pilot Study:Role of Dietary Fiber in PCOS Anovulation

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 Overview

• Status: Terminated
• Conditions: PCOS
• Intervention / Treatment: Drug: Fiber-Stat

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • VCU General Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fiber-Stat; 2 tablespoons daily	Drug: Fiber-Stat; Liquid fiber supplement, 2 tablespoons twice daily.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Paulina A Essah, M.D., Virginia Commonwealth University

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: June 20, 2008
• First Submitted That Met QC Criteria: June 20, 2008
• First Posted (Estimate): June 23, 2008

Study Record Updates

• Last Update Posted (Actual): October 9, 2017
• Last Update Submitted That Met QC Criteria: September 8, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Anovulation
• Other Study ID Numbers: HM11246; 2U54HD034449 (U.S. NIH Grant/Contract)