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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01894581
• Other study ID #: 13-1420
• Secondary ID: U54HD058155-05
• Status: Completed
• Phase: N/A
• First received: July 3, 2013
• Last updated: February 23, 2015
• Start date: July 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fertility
• Obesity

Intervention

Dietary Supplement:
• LOVAZA
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.

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

Locations

Country	Name	City	State
United States	University of Colorado Denver Anschutz Medical Campus	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pituitary and hypothalamic output	To test the pituitary and hypothalamic output, we will examine the LH and FSH 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 (or mass for deconvolution output) for each patient. The average change in pulse amplitude within each group will be compared using a paired t-test.	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.	No
Secondary	Corpus luteum function	To test the corpus luteum function, we will examine daily excretion of urinary sex steroids (E1c, estrone conjugates, and Pdg, pregnanediol glucuronide) across the entire menstrual cycle.	Daily across two menstrual cycles, one prior to dietary supplementation and one after.	No