Pilot Study:Role of Dietary Fiber in PCOS Anovulation
Pilot Study:Role of Dietary Fiber in PCOS Anovulation
The purpose of this study is to determine whether 6 months of fiber supplementation will
 improve ovulation in women with polycystic ovary syndrome (PCOS).
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)