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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Colorado, Denver
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01894581
First received: July 3, 2013
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Obesity
Fertility
Dietary Supplement: LOVAZA
Drug: GnRH

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Dietary Omega-3 Fatty Acids on Reproductive Hormones in Obese Women

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Pituitary and hypothalamic output [ 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Corpus luteum function [ Time Frame: Daily across two menstrual cycles, one prior to dietary supplementation and one after. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: July 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Regimen

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.

In early follicular phase (cycle day 3-6), an intravenous bolus of exogenous GnRH (75 ng/kg dosing based on total body weight) will be administered at 6 hours. Pituitary gonadotropin response will be assessed (as described in C.2.3) to determine how dietary intervention alters pituitary sensitivity to GnRH.

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.
Other Name: Omega-3-acid ethyl esters
Drug: GnRH
An intravenous bolus of exogenous GnRH (75 ng/kg dosing based on total body weight) will be administered at 6 hours.
Other Name: Gonadorelin (GnRH)

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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) 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01894581

Contacts
Contact: Celeste Robledo 303-724-2046 celeste.robledo@ucdenver.edu

Locations
United States, Colorado
University of Colorado Denver Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Celeste Robledo    303-724-2046    celeste.robledo@ucdenver.edu   
Principal Investigator: Alex Polotsky, MD, MS         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Alex Polotsky, MD, MS University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01894581     History of Changes
Other Study ID Numbers: 13-1420, U54HD058155-05
Study First Received: July 3, 2013
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014