N/A
N=39
Effects of Dietary Omega-3 Fatty Acids on Reproductive Hormones in Obese Women
Obesity · Fertility
Bottom Line
View on ClinicalTrials.gov: NCT01894581 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Change in the Average LH Pulse Amplitude — -.04; .4 IU/L
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LOVAZA (Dietary_supplement); GnRH (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Colorado, Denver
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Average LH Pulse Amplitude |
-.04; .4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01894581). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.