EPA for Omega-3 Metabolism

(OMEGA Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Toronto

Must not be taking: Chronic medications

Disqualifiers: High fish intake, Pregnancy, Diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

64 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical study is to learn how fast EPA is converted to other molecules, including DHA, with consideration of biological sex and genetics in healthy humans. The main questions it aims to answer are: * How fast is EPA converted to DHA in blood, and is the conversion rate affected by sex and a specific genotype we previously identified? * How do sex and the specific genotypes affect blood DHA levels and other products of DHA in response to dietary EPA? * How fast does dietary EPA replace blood EPA and other omega-3 fatty acids, and is the rate affected by sex and genotype? Participants will be asked to take EPA supplements for 12 weeks and provide a series of venous blood samples over the study duration.

Eligibility Criteria

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

BMI between 18.5-30 kg/m2

Healthy

Exclusion Criteria

Hypercholesterolemia (serum LDL-C ≥5 mmol/l)

Anticipated changes in lifestyle within the next 4 months

Hypertriglyceridemia (serum ≥ 1.69 mmol/l)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take EPA supplements for 12 weeks and provide venous blood samples

12 weeks

Frequent visits for blood sampling on Day 0, 3, 7, 14, 28, 56, 84

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• EPA

Trial Overview The study tests how fast the body converts EPA to DHA, considering biological sex and specific genotypes. It examines changes in blood levels of DHA and other omega-3 products after taking dietary EPA supplements.

Participant Groups

Group I: EPA Supplementation Experimental Treatment 1 Intervention

32 males and 32 females will be enrolled in the EPA supplementation arm, with an equal number of GA+GG and AA genotypes (rs953413 SNP) among males and females.

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+