Therapeutic Omegas for Triglyceride Suppression

N/AActive Not RecruitingNCT04349475

University of Colorado, Denver40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Pregnancy

Interventions

Eligibility

Sex: ALLMin age: 0 YearsMax age: 39 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

University of Colorado/Anschutz Medical Campus

Aurora, Colorado, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

Maternal Fasting and Postprandial Triglycerides

Differences in maternal fasting and postprandial triglycerides between groups

Time frame: 34 weeks gestational age

Secondary Outcomes

Mesenchymal Stem Cell Differentiation

Differences in Wnt/β-catenin signaling in mesenchymal stem cells between groups

Time frame: Delivery

Placental Nutrient Transport Capacity

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.

Time frame: Delivery

Nutrient Transport Gene expression

Between-group differences in the expression of placental nutrient transporters GLUT1, GLUT4, FATP2, FATP4, FATP6, and FAT/CD36, and SNAT1, SNAT2, SNAT4, LAT1, LAT2.

Time frame: Delivery