Therapeutic Omegas for Triglyceride Suppression

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pregnancy Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

0 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado/Anschutz Medical Campus, Aurora, Colorado, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Intervention Omega 3 Supplementation

Dietary Supplement

Participants will supplement 4g of Omega 3 fish oil daily (750DHA/250EPA)

Placebo Soybean Oil

Dietary Supplement

Participants will supplement 4g of Soybean oil daily

Primary outcomes

Maternal Fasting and Postprandial Triglycerides

Time frame: 34 weeks gestational age

Differences in maternal fasting and postprandial triglycerides between groups

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

University of Oklahoma

Registry information

Official study title

Pilot RCT Intervention Targeting Elevated Triglycerides With a Point-of-Care Meter and Omega-3 Fatty Acids to Normalize Triglycerides and Fetal Growth

Acronym: TOTS

Important dates

Study start: 2021
Primary completion: 2026
Study completion: 2026
First posted: Apr 16, 2020
Registry last updated: May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting