Pilot Study:Role of Dietary Fiber in PCOS Anovulation

Virginia Commonwealth University (VCU)

Status and phase

Terminated

Phase 4

Conditions

PCOS

Treatments

Drug: Fiber-Stat

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00703092

HM11246

2U54HD034449 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to determine whether 6 months of fiber supplementation will improve ovulation in women with polycystic ovary syndrome (PCOS).

Full 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.

Enrollment

2 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts 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)