Therapeutic Omegas for Triglyceride Suppression

NCT04349475 | Active Not Recruiting

• 1 other identifier: 20-0707
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Pregnancy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Maternal Fasting and Postprandial Triglycerides

  Differences in maternal fasting and postprandial triglycerides between groups

  34 weeks gestational age

Study Arms (2)

Omega 3 Supplementation

EXPERIMENTAL

Supplementation of 4g of DHA/EPA daily

Dietary Supplement: Intervention Omega 3 Supplementation

Safflower Oil Supplement

PLACEBO COMPARATOR

Supplementation of Safflower Oil daily

Dietary Supplement: Control Safflower Oil

Interventions

Intervention Omega 3 Supplementation DIETARY_SUPPLEMENT

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

Omega 3 Supplementation

Control Safflower Oil DIETARY_SUPPLEMENT

Participants will consume 2.5g of a Safflower oil supplement daily

Safflower Oil Supplement

Eligibility Criteria

• Age: 0 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• University of Oklahoma: collaborator

Study Sites (2)

University of Colorado/Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related 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.

  PMID: 29931812 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Teri L Hernandez, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 16, 2020
• Study Start: November 29, 2021
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

US (2)