Effects of Dietary Omega-3 Fatty Acids on Reproductive Hormones in Obese Women

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: Female

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, menstrual cycle abnormalities, subfertility, fetal loss, obstetrical complications and congenital anomalies. Changes in reproductive hormones and diminished oocyte quality have also been demonstrated. A gap of knowledge exists as the mechanisms underlying these harmful effects are poorly understood and no specific treatments exist.

This proposal will test the hypothesis that dietary omega-3 fatty acids (FA) will improve the output of hypothalamicpituitary- ovarian axis in obese women. The investigators will perform paired assessments before and after supplementation in 10 obese and 10 normal weight women. To test the pituitary and hypothalamic output, the investigators will examine the luteinizing hormone (LH) and follicle-stimulating hormone (FSH) responsiveness during frequent blood sampling. To test the corpus luteum function, the investigators will examine urinary reproductive hormones (E1c, estrone conjugates, and pregnanediol glucuronide (Pdg)) over an entire menstrual cycle. The investigators ultimate goal is to collect preliminary data for an adequately powered randomized control trial.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Hormones; Prolactin Release-Inhibiting Factors

Criteria

Inclusion Criteria:

1. Age 18-42 at study entry

2. Regular menstrual cycles every 25-40 days

3. BMI at least 30 kg/m2 (obese) or between 18.5 and 25 kg/m2 (normal)

4. Good general health

5. Prolactin and thyroid-stimulating hormone (TSH) within normal laboratory ranges at screening, baseline hemoglobin >11 gm/dl.

Exclusion Criteria:

1. Diagnosis of polycystic ovary syndrome (by ultrasound or hyperandrogenic symptoms)

2. Fish or seafood allergy or hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters or any component of the formulation

3. Coagulopathy or receiving therapeutic anticoagulation (due to potential for interaction with omega-3 FA)

4. History of chronic disease affecting hormone production, metabolism or clearance (including diabetes mellitus)

5. Abnormal renal or liver function at screening

6. Current use of thiazolidinediones or metformin (known to interact with reproductive hormones)

7. Use of hormones affecting hypothalamic output (HPO) axis (such as hormonal contraceptives) within three months of entry

8. Strenuous exercise (>4 hours of intense physical activity per week)

9. Pregnancy

10. Breast-feeding

11. Current active attempts to conceive

12. History of significant recent weight loss or gain