Pilot Study:Role of Dietary Fiber in PCOS Anovulation

PCOS Clinical Trial

Official title:

Pilot Study: Role of Dietary Fiber in PCOS Anovulation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00703092
• Other study ID #: HM11246
• Secondary ID: 2U54HD034449
• Status: Terminated
• Phase: Phase 4
• First received: June 20, 2008
• Last updated: September 8, 2017
• Start date: February 2008
• Est. completion date: March 2010

Study information

• Verified date: September 2017
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anovulation
• PCOS

Intervention

Drug:
• Fiber-Stat
Liquid fiber supplement, 2 tablespoons twice daily.

Locations

Country	Name	City	State
United States	VCU General Clinical Research Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quantify Enrollment Strategies, Retention, Compliance, Participant Characteristics, and Data Collection Challenges.		10 months