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Recruiting Phase 4 NCT06975241

Observing Metabolism of EPA With Consideration of Genetics And Sex

Trial Parameters

Condition Healthy
Sponsor University of Toronto
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 64
Sex ALL
Min Age 18 Years
Max Age 35 Years
Start Date 2025-07-29
Completion 2026-09
Interventions
EPA 2.4g/day

Brief Summary

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

Inclusion Criteria: * BMI between 18.5- 30 kg/m2 * healthy Exclusion Criteria: * Consumption of fish/seafood or EPA/DHA-enriched foods currently or within the previous 6 months * Consumption of any supplements containing ALA/EPA/DHA currently or within the previous 6 months * Allergies to any component of the study supplement (fish, gelatin etc.) * BMI \<18.5 kg/m² or \>30 kg/m² * Women who are pregnant, breastfeeding or planning on becoming pregnant * Diagnosis with chronic or communicable diseases * Prescription of chronic pharmacological medications (except for oral contraceptives) * High blood pressure (systolic or diastolic blood pressure above 130 or 80mmHg, respectively) * Hypertriglyceridemia (serum \> or = 1.69 mmol/l) * Hypercholesterolemia (serum LDL-C \> or =5 mmol/l) * Anticipated changes in lifestyle within the next 4 months * Smoking * Heavy alcohol use (\>3 drinks/day) * Major surgery in the last six months

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