Pilot RCT Intervention Targeting Elevated Triglycerides With a Point-of-Care Meter and Omega-3 Fatty Acids to Normalize Triglycerides and Fetal Growth
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Maternal Fasting and Postprandial Triglycerides
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 0 Years to 39 Years (Child, Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Omega 3 Supplementation
Supplementation of 4g of DHA/EPA daily
Intervention: Intervention Omega 3 Supplementation (Dietary Supplement)
Soybean oil
Supplementation of 4g Soybean Oil
Intervention: Placebo Soybean Oil (Dietary Supplement)
Outcomes
Primary Outcomes
Maternal Fasting and Postprandial Triglycerides
Time Frame: 34 weeks gestational age
Differences in maternal fasting and postprandial triglycerides between groups
Secondary Outcomes
- Mesenchymal Stem Cell Differentiation(Delivery)
- Placental Nutrient Transport Capacity(Delivery)
- Nutrient Transport Gene expression(Delivery)