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

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ClinicalTrials.gov Identifier: NCT01894581
Recruitment Status : Completed
First Posted : July 10, 2013
Results First Posted : July 13, 2016
Last Update Posted : February 2, 2017
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Obesity
Fertility
Interventions Dietary Supplement: LOVAZA
Drug: GnRH
Enrollment 39
Recruitment Details 39 regularly menstruating obese and normal-weight women were recruited from the community through campus-wide advertisements.
Pre-assignment Details Potential participants were screened out if they had polycystic ovary syndrome, allergies to seafood, used medications known to affect reproductive hormones, used exogenous sex steroids within the last 3 months, exercised vigorously more than 4 hours weekly, or were attempting pregnancy. Eligible subjects then had a baseline physical examination.
Arm/Group Title Obese Normal Weight
Hide Arm/Group Description BMI >= 30 kg/m2 BMI 18-25 kg/m2
Period Title: Overall Study
Started 20 19
Completed 15 12
Not Completed 5 7
Reason Not Completed
Withdrawal by Subject             2             3
Screen Failure             3             4
Arm/Group Title Obese Normal Weight Total
Hide Arm/Group Description BMI >= 30 kg/m2 BMI 18-25 kg/m2 Total of all reporting groups
Overall Number of Baseline Participants 20 19 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 19 participants 39 participants
34.8  (1.2) 28.4  (1.2) 31.6  (5.3)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 39 participants
Female 15 12 27
Male 0 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 19 participants 39 participants
15 12 27
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 20 participants 19 participants 39 participants
37.8  (1.5) 21.8  (.5) 31.6  (9.1)
1.Primary Outcome
Title Change in the Average LH Pulse Amplitude
Hide 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.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Obese Normal Weight
Hide Arm/Group Description:
BMI >= 30 kg/m2
BMI 18-25 kg/m2
Overall Number of Participants Analyzed 15 12
Mean (Standard Deviation)
Unit of Measure: IU/L
-.04  (.2) .4  (.4)
Time Frame During approximately one menstrual cycle.
Adverse Event Reporting Description Adverse event data were collected for the duration of the participant's participation, which was approximately one menstrual cycle. Data were from all subjects were collected from June of 2013 to February of 2015.
 
Arm/Group Title Obese Normal Weight
Hide Arm/Group Description BMI >= 30 kg/m2 BMI 18-25 kg/m2
All-Cause Mortality
Obese Normal Weight
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Obese Normal Weight
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Obese Normal Weight
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/12 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Alex Polotsky
Organization: University of Colorado Denver
Phone: 303-724-2001
EMail: alex.polotsky@ucdenver.edu
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01894581     History of Changes
Other Study ID Numbers: 13-1420
U54HD058155-05 ( U.S. NIH Grant/Contract )
First Submitted: July 3, 2013
First Posted: July 10, 2013
Results First Submitted: June 2, 2016
Results First Posted: July 13, 2016
Last Update Posted: February 2, 2017