EPA for Omega-3 Metabolism
(OMEGA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the conversion rate of the omega-3 fatty acid EPA (eicosapentaenoic acid) into other important molecules, such as DHA, in the body. It examines how this process might vary between men and women or due to genetic differences. Participants will take EPA supplements for 12 weeks and provide blood samples to aid researchers in understanding these changes. The study seeks healthy individuals with a BMI between 18.5 and 30 kg/m² who do not frequently consume fish or take omega-3 supplements. As a Phase 4 trial, this research aims to understand how the already FDA-approved treatment benefits a broader range of patients.
Do I have to stop taking my current medications for the trial?
Yes, you will need to stop taking any chronic prescription medications, except for oral contraceptives, to participate in this trial.
What is the safety track record for this treatment?
Research shows that EPA (eicosapentaenoic acid) is generally safe for use. Studies indicate that taking EPA as a prescription drug or in fish oil is likely safe for up to seven years. Most side effects are mild, such as a fishy aftertaste, mild stomach upset, or loose stools.
Clinical studies have found that EPA lowers triglyceride levels, which are fats in the blood. This can benefit those looking to support heart health. Prescription omega-3 fatty acids, which include EPA, are usually well-tolerated, though they can cause minor side effects, which are rare.
Overall, evidence suggests that EPA is a safe choice for those considering joining a clinical trial involving this supplement.12345Why are researchers enthusiastic about this study treatment?
Unlike standard treatments for omega-3 metabolism that often focus on a blend of omega-3 fatty acids like EPA and DHA, this study treatment uses pure EPA (eicosapentaenoic acid) supplementation. Researchers are excited about this approach because EPA is thought to have a unique role in reducing inflammation and improving heart health, potentially offering more targeted benefits. By focusing solely on EPA, this treatment could provide clearer insights into its specific effects and advantages over mixed omega-3 formulations.
What evidence suggests that EPA supplementation is effective for omega-3 metabolism?
Research has shown that omega-3 fatty acids, such as EPA, benefit heart health. This trial will focus on EPA supplementation, which studies indicate can lower the risk of heart problems, particularly when taken alone. EPA helps manage triglycerides, total cholesterol, and insulin resistance. Evidence also suggests that high doses of omega-3s can affect metabolism and reduce inflammation in certain conditions. Although results on overall heart events are mixed, EPA's specific benefits for heart health and metabolism are well-supported.678910
Are You a Good Fit for This Trial?
This trial is for healthy individuals interested in how their body processes a type of Omega-3 fatty acid. Participants will take EPA supplements daily and give blood samples regularly over 12 weeks. The study focuses on the effects of sex and genetics on metabolism.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants take EPA supplements for 12 weeks and provide venous blood samples
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- EPA
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Toronto
Lead Sponsor