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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
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PCOS

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

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)
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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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