Pilot Study:Role of Dietary Fiber in PCOS Anovulation
Primary Purpose
PCOS
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fiber-Stat
Sponsored by
About this trial
This is an interventional treatment trial for PCOS
Eligibility 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)
Sites / Locations
- VCU General Clinical Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fiber-Stat
Arm Description
2 tablespoons daily
Outcomes
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.
Secondary Outcome Measures
Quantify Enrollment Strategies, Retention, Compliance, Participant Characteristics, and Data Collection Challenges.
Full Information
NCT ID
NCT00703092
First Posted
June 20, 2008
Last Updated
September 8, 2017
Sponsor
Virginia Commonwealth University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00703092
Brief Title
Pilot Study:Role of Dietary Fiber in PCOS Anovulation
Official Title
Pilot Study: Role of Dietary Fiber in PCOS Anovulation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
P.I. left University. Study terminated
Study Start Date
February 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PCOS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fiber-Stat
Arm Type
Experimental
Arm Description
2 tablespoons daily
Intervention Type
Drug
Intervention Name(s)
Fiber-Stat
Intervention Description
Liquid fiber supplement, 2 tablespoons twice daily.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Quantify Enrollment Strategies, Retention, Compliance, Participant Characteristics, and Data Collection Challenges.
Time Frame
10 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulina A Essah, M.D.
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
VCU General Clinical Research Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.vcu.edu/pcos
Description
Related Info
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Pilot Study:Role of Dietary Fiber in PCOS Anovulation
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