Polycystic Ovarian Syndrome: Impact of Flaxseed Supplementation
Polycystic Ovarian Syndrome: Impact of Flaxseed Supplementation
The overall aim of this study is to explore the effects of flaxseed supplementation and
 determine whether it is a feasible and potentially effective dietary intervention among women
 with polycystic ovarian syndrome (PCOS). Women, ages 18-45, with clinically confirmed PCOS
 (N=20) will be scheduled for baseline measures and then instructed and given supplies
 necessary to follow a flaxseed supplemented (30 g/day) diet for a period of three months,
 whereupon follow-up measures will be taken. Subjects will be asked to resume their typical
 (unsupplemented) diet for another three months and a second set of follow-up measures will be
 taken. Baseline levels of bioavailable and total testosterone, fasting insulin, glucose, and
 triglycerides (TG), total/LDL/HDL cholesterol, body weight, degree of hirsutism and acne, and
 menstrual cyclicity will be compared to levels at 3 and 6 month follow-up. The overall
 hypothesis (based upon our work in men at risk for prostate cancer and data from one
 case-study conducted in a woman with confirmed PCOS) is that during the time women receive
 flaxseed supplementation they will experience reduced serum levels of testosterone, and total
 and LDL cholesterol, as well as clinical evidence of hirsutism. Given the pilot nature of
 this study, statistical analyses will be limited to simple descriptive statistics. We have
 observed no negative side effects, other than minor gastro-intestinal occurrences (i.e.,
 temporary increased flatulence, borborygmi, increased number of stools, etc.) associated with
 flaxseed supplementation in our previous studies either with short or long-term use. Flaxseed
 supplementation will be discontinued if indicated and the events reported to the
 institutional review board.
Inclusion Criteria:

 -  limited to women aged 18-45

 -  diagnosis of PCOS by menstrual irregularity (fewer than 9 menses annually),
 Ferriman-Gallwey score > 8, and/or hyperandrogenemia defined as bioavailable
 T>8.4ng/dL (Zawdaki & Dunaif 1992)

 -  mentally competent

 -  English speaking/writing

 -  telephone access and/or email access

 Exclusion Criteria:

 -  Use of oral contraceptives, spironolactone or insulin-sensitizing agents within the
 past 3 months;

 -  Long-term or chronic use of oral antibiotics;

 -  Diagnoses of hyperprolactinemia, thyroid abnormalities, or nonclassic adrenal
 hyperplasia;

 -  Hysterectomy;

 -  Onset of menopause;

 -  Pregnancy/Lactation;

 -  Consumption of flaxseed within the past month; and

 -  Use of any dietary fiber supplements which are newly started (within the past 6
 months) and agreement not to use any new fiber supplements during the study period