Trial Outcomes & Findings for Effects of Dietary Omega-3 Fatty Acids on Reproductive Hormones in Obese Women (NCT NCT01894581)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

39 participants

Primary outcome timeframe

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.

Results posted on

2017-02-02

Participant Flow

39 regularly menstruating obese and normal-weight women were recruited from the community through campus-wide advertisements.

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.

Participant milestones

Participant milestones
Measure	Obese BMI \>= 30 kg/m2	Normal Weight BMI 18-25 kg/m2
Overall Study STARTED	20	19
Overall Study COMPLETED	15	12
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Obese BMI \>= 30 kg/m2	Normal Weight BMI 18-25 kg/m2
Overall Study Withdrawal by Subject	2	3
Overall Study Screen Failure	3	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Obese n=20 Participants BMI \>= 30 kg/m2	Normal Weight n=19 Participants BMI 18-25 kg/m2	Total n=39 Participants Total of all reporting groups
Age, Continuous	34.8 years STANDARD_DEVIATION 1.2 • n=5 Participants	28.4 years STANDARD_DEVIATION 1.2 • n=7 Participants	31.6 years STANDARD_DEVIATION 5.3 • n=5 Participants
Sex/Gender, Customized Female	15 participants n=5 Participants	12 participants n=7 Participants	27 participants n=5 Participants
Sex/Gender, Customized Male	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	12 participants n=7 Participants	27 participants n=5 Participants
BMI	37.8 kg/m^2 STANDARD_DEVIATION 1.5 • n=5 Participants	21.8 kg/m^2 STANDARD_DEVIATION .5 • n=7 Participants	31.6 kg/m^2 STANDARD_DEVIATION 9.1 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Obese n=15 Participants BMI \>= 30 kg/m2	Normal Weight n=12 Participants BMI 18-25 kg/m2
Change in the Average LH Pulse Amplitude	-.04 IU/L Standard Deviation .2	.4 IU/L Standard Deviation .4

Adverse Events

Obese

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Weight

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alex Polotsky

University of Colorado Denver

Phone: 303-724-2001

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place