Pilot Study:Role of Dietary Fiber in PCOS Anovulation

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.

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)