Flaxseed Lignan (Brevail)

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Kansas Medical Center

Criteria

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.