Therapeutic Omegas for Triglyceride Suppression

Not Applicable

Recruiting

• Conditions: Pregnancy
• Interventions: Dietary Supplement: Intervention Omega 3 Supplementation; Dietary Supplement: Control Safflower Oil

• Registration Number: NCT04349475
• Lead Sponsor: University of Colorado, Denver

Brief Summary

This study plans to learn more about how an omega-3 fatty acid supplement effects triglyceride levels in pregnancy. Triglycerides are a type of fat found in your blood. Your body converts extra calories into triglycerides to be stored and used later for energy. It is normal for triglyceride levels to go up during pregnancy however some women have levels that are \~30-40% higher than normal when they reach their third trimester of pregnancy. Having high triglycerides in pregnancy may be related to an increased chance of having a baby that is large for their age. The goal of this study is to determine if taking an omega-3 fatty acid supplement can slow the rise in triglyceride levels later in pregnancy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-13
• Study First Submitted QC: 2020-04-13
• Study First Posted: 2020-04-16
• Study Start: 2021-11-29
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Pregnant women between the ages of 21-39 yrs
• Pre-pregnancy BMI 28-39
• Fasting Triglyceride ≥120 mg/dL measured by 15 wks

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Exclusion Criteria

• Pre-gestational diabetes or prediabetes
• History of gestational diabetes,
• History of pre-eclampsia, spontaneous pre-term delivery, or gestational hypertension <34wks
• Tobacco or illicit substance use
• Chronic steroid use

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omega 3 Supplementation	Intervention Omega 3 Supplementation	Supplementation of 4g of DHA/EPA daily
Safflower Oil Supplement	Control Safflower Oil	Supplementation of Safflower Oil daily

Primary Outcome Measures

Name	Time	Method
Maternal Fasting and Postprandial Triglycerides	34 weeks gestational age	Differences in maternal fasting and postprandial triglycerides between groups

Trial Locations

Locations (2)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States

University of Colorado/Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States