Therapeutic Omegas for Triglyceride Suppression (TOTS)
August 26, 2026 updated by: University of Colorado, Denver
Pilot RCT Intervention Targeting Elevated Triglycerides With a Point-of-Care Meter and Omega-3 Fatty Acids to Normalize Triglycerides and Fetal Growth
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado/Anschutz Medical Campus
-
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Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 35 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Omega 3 Supplementation
Supplementation of 4g of DHA/EPA daily
|
Participants will supplement 4g of Omega 3 fish oil daily (750DHA/250EPA)
|
|
Placebo Comparator: Soybean oil
Supplementation of 4g Soybean Oil
|
Participants will supplement 4g of Soybean oil daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maternal Fasting and Postprandial Triglycerides
Time Frame: 34 weeks gestational age
|
Differences in maternal fasting and postprandial triglycerides between groups
|
34 weeks gestational age
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mesenchymal Stem Cell Differentiation
Time Frame: Delivery
|
Differences in Wnt/β-catenin signaling in mesenchymal stem cells between groups
|
Delivery
|
|
Placental Nutrient Transport Capacity
Time Frame: Delivery
|
We will evaluate placental nutrient-sensing pathways that regulate transporter activity by measuring the abundance and phosphorylation of key components of the insulin/PI3K/Akt and mTOR signaling pathways, including Akt, mTOR, 4E-BP1, and S6K/rpS6, to determine whether O-3 FA supplementation improves placental nutrient sensing and transport regulation.
|
Delivery
|
|
Nutrient Transport Gene expression
Time Frame: Delivery
|
Between-group differences in the expression of placental nutrient transporters GLUT1, GLUT4, FATP2, FATP4, FATP6, and FAT/CD36, and SNAT1, SNAT2, SNAT4, LAT1, LAT2.
|
Delivery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Teri L Hernandez, PhD, University of Colorado, Denver
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 29, 2021
Primary Completion (Actual)
April 30, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
April 13, 2020
First Submitted That Met QC Criteria
April 13, 2020
First Posted (Actual)
April 16, 2020
Study Record Updates
Last Update Posted (Actual)
August 31, 2026
Last Update Submitted That Met QC Criteria
August 26, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-0707
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.