Therapeutic Omegas for Triglyceride Suppression

Pregnancy Clinical Trial

— TOTS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04349475
• Other study ID #: 20-0707
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2021
• Est. completion date: December 2023

Study information

• Verified date: May 2023
• Source: University of Colorado, Denver
• Contact: Teri L Hernandez, PhD
• Phone: 303-724-8538
• Email: Teri.Hernandez[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

Dietary Supplement:
• Intervention Omega 3 Supplementation
Participants will supplement 4g of Omega 3 fish oil daily (750DHA/250EPA)
• Control Safflower Oil
Participants will consume 2.5g of a Safflower oil supplement daily

Locations

Country	Name	City	State
United States	University of Colorado/Anschutz Medical Campus	Aurora	Colorado
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	University of Oklahoma

Country where clinical trial is conducted

United States, 

References & Publications (1)

Barbour LA, Farabi SS, Friedman JE, Hirsch NM, Reece MS, Van Pelt RE, Hernandez TL. Postprandial Triglycerides Predict Newborn Fat More Strongly than Glucose in Women with Obesity in Early Pregnancy. Obesity (Silver Spring). 2018 Aug;26(8):1347-1356. doi: 10.1002/oby.22246. Epub 2018 Jun 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal Fasting and Postprandial Triglycerides	Differences in maternal fasting and postprandial triglycerides between groups	34 weeks gestational age