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Pilot Study:Role of Dietary Fiber in PCOS Anovulation

This study has been terminated.
(P.I. left University. Study terminated)
Information provided by (Responsible Party):
Virginia Commonwealth University Identifier:
First received: June 20, 2008
Last updated: June 27, 2014
Last verified: June 2014
The purpose of this study is to determine whether 6 months of fiber supplementation will improve ovulation in women with polycystic ovary syndrome (PCOS).

Condition Intervention Phase
PCOS Drug: Fiber-Stat Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study: Role of Dietary Fiber in PCOS Anovulation

Resource links provided by NLM:

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • 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. [ Time Frame: 10 months ]

Secondary Outcome Measures:
  • Quantify Enrollment Strategies, Retention, Compliance, Participant Characteristics, and Data Collection Challenges. [ Time Frame: 10 months ]

Enrollment: 2
Study Start Date: February 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fiber-Stat
2 tablespoons daily
Drug: Fiber-Stat
Liquid fiber supplement, 2 tablespoons twice daily.

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.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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)
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Please refer to this study by its identifier: NCT00703092

United States, Virginia
VCU General Clinical Research Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Principal Investigator: Paulina A Essah, M.D. Virginia Commonwealth University
  More Information

Responsible Party: Virginia Commonwealth University Identifier: NCT00703092     History of Changes
Other Study ID Numbers: VCU IRB HM11246
2U54HD034449 ( U.S. NIH Grant/Contract )
Study First Received: June 20, 2008
Results First Received: May 27, 2014
Last Updated: June 27, 2014

Additional relevant MeSH terms:
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases processed this record on August 17, 2017