Therapeutic Omegas for Triglyceride Suppression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-29

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Omega 3 Supplementation

Supplementation of 4g of DHA/EPA daily

Group Type EXPERIMENTAL

Intervention Omega 3 Supplementation

Intervention Type DIETARY_SUPPLEMENT

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

Safflower Oil Supplement

Supplementation of Safflower Oil daily

Group Type PLACEBO_COMPARATOR

Control Safflower Oil

Intervention Type DIETARY_SUPPLEMENT

Participants will consume 2.5g of a Safflower oil supplement daily

Interventions

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Intervention Omega 3 Supplementation

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

Intervention Type DIETARY_SUPPLEMENT

Control Safflower Oil

Participants will consume 2.5g of a Safflower oil supplement daily

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

0 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes