Flaxseed Lignan (Brevail)

Impact of Flaxseed Lignan (Brevail) on Polycystic Ovarian Syndrome

PCOS is a disorder which is characterized by hyperandrogenism (high serum male hormone levels), ovulatory dysfunction, and polycystic ovaries (multiple follicles-over 12- in the ovary). There is no universally accepted definition for PCOS. The Rotterdam criteria require 2 of 3 criteria for diagnosis, including hyperandrogenism (clinical hirsutism or serum hormone measurement), oligomenorrhea/amenorrhea, and ultrasound findings of polycystic ovaries.

This study is a prospective randomized pilot study designed to evaluate the effects of flaxseed supplementation (with Brevail) on hormonal and lipid metabolism balance in polycystic ovarian syndrome (PCOS) patients.

Inclusion Criteria:

• Must be 18 to 40 year old female with:
• Diagnosis of PCOS by menstrual irregularity (fewer than 9 menses annually/interval over 40 days), Ferriman-Galleway score >8, and/or hyperandrogenemia defined as total testosterone >80ng/dl or bioavailable testosterone >8.4 ng/dl.
• Mentally competent.

Exclusion Criteria:

• Use of oral contraceptives, spironolactone, or insulin-sensitizing agents within the past 2 months.
• Long-term or chronic use of oral antibiotics.
• Hysterectomy.
• FSH >15.
• Pregnancy/lactation.
• Consumption of flaxseed within the last month.
• Diagnosis of thyroid disease, nonclassical adrenal hyperplasia, and hyperprolactinemia.
• 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.