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

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.

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Key information

Conditions

Obesity Body Weight Fertility Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Denver Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LOVAZA

Dietary Supplement

Subjects will be instructed to take 2 grams twice daily of oral omega-3-acid ethyl esters (Lovaza) starting with day 1 to 3 of their menstrual period. Each capsule contains 60mg of other omega-3 FA. On day 1 of their subsequent menstrual period, subjects will be instructed to discontinue.

Other names: Omega-3-acid ethyl esters

GnRH

Drug

An intravenous bolus of exogenous GnRH (75 ng/kg dosing based on total body weight) will be administered at 6 hours.

Other names: Gonadorelin (GnRH)

Primary outcomes

Change in the Average LH Pulse Amplitude

Time frame: 10 minute intervals during 8 hour blood sampling studies. Subjects will undergo two menstrual cycles of study, one prior to dietary supplementation and one after supplementation.

To test the pituitary and hypothalamic output, we examined LH secretion (unstimulated and in response to gonadotropin-releasing hormone (GnRH) stimulation) during 8-hour blood sampling studies at 10 min intervals. The primary outcome measure is the change in the average LH pulse amplitude for each patient from baseline to after supplementation.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Jul 10, 2013
Registry last updated: Feb 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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