Flaxseed Lignan (Brevail)
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 4/21/2016 |
| Start Date: | June 2011 |
| End Date: | December 2013 |
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.
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.
We found this trial at
1
site
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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