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Therapeutic Omegas for Triglyceride Suppression

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04349475
Acronym
TOTS
Enrollment
40
Registered
2020-04-16
Start date
2021-11-29
Completion date
2026-12-31
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

triglycerides, glucose, adiposity, Air displacement plethysmography, Continuous glucose monitoring

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.

Interventions

DIETARY_SUPPLEMENTIntervention Omega 3 Supplementation

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

DIETARY_SUPPLEMENTPlacebo Soybean Oil

Participants will supplement 4g of Soybean oil daily

Sponsors

University of Colorado, Denver
Lead SponsorOTHER
University of Oklahoma
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
0 Years to 39 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Maternal Fasting and Postprandial Triglycerides34 weeks gestational ageDifferences in maternal fasting and postprandial triglycerides between groups

Secondary

MeasureTime frameDescription
Mesenchymal Stem Cell DifferentiationDeliveryDifferences in Wnt/β-catenin signaling in mesenchymal stem cells between groups
Placental Nutrient Transport CapacityDeliveryWe 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.
Nutrient Transport Gene expressionDeliveryBetween-group differences in the expression of placental nutrient transporters GLUT1, GLUT4, FATP2, FATP4, FATP6, and FAT/CD36, and SNAT1, SNAT2, SNAT4, LAT1, LAT2.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORTeri L Hernandez, PhD

University of Colorado, Denver

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026