Status:
COMPLETED
Effects of Dietary Omega-3 Fatty Acids on Reproductive Hormones in Obese Women
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Obesity
Fertility
Eligibility:
FEMALE
18-42 years
Phase:
NA
Brief Summary
The United States has the highest prevalence of obesity among all countries surveyed in 2012 by the Organization for Economic Cooperation and Development. Maternal obesity is linked with anovulation, ...
Eligibility Criteria
Inclusion
- Age 18-42 at study entry
- Regular menstrual cycles every 25-40 days
- BMI at least 30 kg/m2 (obese) or between 18.5 and 25 kg/m2 (normal)
- Good general health
- Prolactin and thyroid-stimulating hormone (TSH) within normal laboratory ranges at screening, baseline hemoglobin \>11 gm/dl.
Exclusion
- Diagnosis of polycystic ovary syndrome (by ultrasound or hyperandrogenic symptoms)
- Fish or seafood allergy or hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters or any component of the formulation
- Coagulopathy or receiving therapeutic anticoagulation (due to potential for interaction with omega-3 FA)
- History of chronic disease affecting hormone production, metabolism or clearance (including diabetes mellitus)
- Abnormal renal or liver function at screening
- Current use of thiazolidinediones or metformin (known to interact with reproductive hormones)
- Use of hormones affecting hypothalamic output (HPO) axis (such as hormonal contraceptives) within three months of entry
- Strenuous exercise (\>4 hours of intense physical activity per week)
- Pregnancy
- Breast-feeding
- Current active attempts to conceive
- History of significant recent weight loss or gain
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01894581
Start Date
July 1 2014
End Date
December 1 2014
Last Update
February 2 2017
Active Locations (1)
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1
University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, United States, 80045