Effects of Dietary Omega-3 Fatty Acids on Reproductive Hormones in Obese Women
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Women's Studies |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 42 |
| Updated: | 2/8/2015 |
| Start Date: | July 2014 |
| End Date: | December 2015 |
| Contact: | Celeste Robledo |
| Email: | celeste.robledo@ucdenver.edu |
| Phone: | 303-724-2046 |
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 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 Pdg, pregnanediol glucuronide) over an
entire menstrual cycle. Our ultimate goal is to collect preliminary data for an adequately
powered randomized control trial.
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 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 Pdg, pregnanediol glucuronide) over an
entire menstrual cycle. Our ultimate goal is to collect preliminary data for an adequately
powered randomized control trial.
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) or abnormal renal or liver function at screening
Current use of thiazolidinediones or metformin(known to interact with reproductive
hormones)
5. Use of hormones affecting hypothalamic output (HPO) axis (such as hormonal
contraceptives) within three months of entry
6. Strenuous exercise (>4 hours of intense physical activity per week)
7. Pregnancy, breast-feeding or current active attempts to conceive
8. History of significant recent weight loss or gain
We found this trial at
1
site
Click here to add this to my saved trials
