Trial · Interventional

CompletedNot applicableResults postedRegistry data

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

NCTNCT01894581Other id13-1420Other idU54HD058155-05

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Overview

Status: Completed
Phase: Not applicable
Enrollment: 39 participants (actual)
Sponsor: University of Colorado, Denver · Other
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: Jul 2014
Primary completion: Dec 2014
Completion: Dec 2014
First posted: 10 Jul 2013 (estimated)
Last update posted: 2 Feb 2017 (estimated)
Conditions: Obesity · Fertility

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20142015

N/A
Effects of Dietary Omega-3 Fatty Acids on Reproductive Hormones in Obese Women
NCT01894581
Jul 2014 to Dec 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

LOVAZADietary supplement
GnRHDrug

Arms2

Experimental
Obese Women
Women with a BMI of greater than or equal to 30 kg/m2 underwent all study interventions, including taking 5 g daily of LOVAZA. Women underwent 8 hours of frequent blood sampling every 10 minutes both at baseline and after LOVAZA supplementation. Each frequent blood sampling included IV administration of GnRH at 6 hours.
Active comparator
Normal Weight
Women with a BMI of between 18-25 kg/m2 underwent all study interventions, including taking 5 g daily of LOVAZA for one cycle. Women underwent 8 hours of frequent blood sampling every 10 minutes both at baseline and after LOVAZA supplementation. Each frequent blood sampling included IV administration of GnRH at 6 hours.

Primary outcomes1

Outcomes the sponsor listed as primary.

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.
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 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.

Change in the Average LH Pulse Amplitude

Group	Value (IU/L)	Spread
Obese	-.04	.2
Normal Weight	.4	.4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
ObeseBMI \>= 30 kg/m2	–	0 / 15	0 / 15
Normal WeightBMI 18-25 kg/m2	–	0 / 12	0 / 12

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedBauer JL, Kuhn K, Bradford AP, Al-Safi ZA, Harris MA, Eckel RH, Robledo CY, Malkhasyan A, Johnson J, Gee NR, Polotsky AJ. Reduction in FSH Throughout the Menstrual Cycle After Omega-3 Fatty Acid Supplementation in Young Normal Weight but not Obese Women. Reprod Sci. 2019 Aug;26(8):1025-1033. doi: 10.1177/1933719119828099. Epub 2019 Feb 17. PMID 30773100
DerivedAl-Safi ZA, Liu H, Carlson NE, Chosich J, Harris M, Bradford AP, Robledo C, Eckel RH, Polotsky AJ. Omega-3 Fatty Acid Supplementation Lowers Serum FSH in Normal Weight But Not Obese Women. J Clin Endocrinol Metab. 2016 Jan;101(1):324-33. doi: 10.1210/jc.2015-2913. Epub 2015 Nov 2. PMID 26523525

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 42 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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) 5. Abnormal renal or liver function at screening 6. Current use of thiazolidinediones or metformin (known to interact with reproductive hormones) 7. Use of hormones affecting hypothalamic output (HPO) axis (such as hormonal contraceptives) within three months of entry 8. Strenuous exercise (\>4 hours of intense physical activity per week) 9. Pregnancy 10. Breast-feeding 11. Current active attempts to conceive 12. History of significant recent weight loss or gain

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