A Phase 4 interventional study of EPA 2.4g/day in Healthy, Omega 3 and Metabolism, Lipids, sponsored by University of Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by University of Toronto · Phase 4, Interventional, and Basic science
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:
Participants will be asked to take EPA supplements for 12 weeks and provide a series of venous blood samples over the study duration.
University of Toronto is the lead sponsor of 397 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Dietary Supplement: EPA 2.4g/day
EPA from fish oil will be supplemented to an equal number of males and females for 12 weeks.
Plasma DHA synthesis/turnover rates
Plasma DHA synthesis/turnover rates (nmol/mL/day) by sex and rs953413 ELOVL2 polymorphism will be determined. DHA synthesis/turnover rates will be calculated from frequent sampling of plasma DHA levels and carbon-13 isotope signatures of DHA (δ13C-DHA) over 12 weeks.
Time frame: Day 0, 3, 7, 14, 28, 56, 84
Changes in plasma DHA concentrations (nmol/ml)
Changes in plasma DHA concentrations by sex and rs953413 ELOVL2 polymorphism will be determined.
Time frame: Baseline and 12 weeks
Plasma EPA turnover rates (nmol/ml/day)
Plasma EPA turnover rates (nmol/mL/day) by sex and rs953413 ELOVL2 polymorphism will be determined. EPA turnover rates will be calculated from frequent sampling of plasma EPA levels and carbon-13 isotope signatures of EPA (δ13C-EPA) over 12 weeks.
Time frame: Day 0, 3, 7, 14, 28, 56, 84
Plasma DPAn-3 synthesis/turnover rates (nmol/ml/day)
Plasma DPAn-3 synthesis/turnover rates (nmol/mL/day) by sex and rs953413 ELOVL2 polymorphism will be determined. DPAn-3 synthesis/turnover rates will be calculated from frequent sampling of plasma DPAn-3 levels and carbon-13 isotope signatures of DPAn-3 (δ13C-DPAn-3) over 12 weeks.
Time frame: Day 0, 3, 7, 14, 28, 56, 84
Changes in PUFA derived eicosanoid/docosanoid levels
Changes in n-3 and n-6 PUFA derived eicosanoid/docosanoid levels by sex and rs953413 ELOVL2 polymorphism will be investigated.
Time frame: Baseline, 4 weeks and 12 weeks
Plasma half-lives of EPA and downstream n-3 PUFAs
Plasma half-lives of EPA and downstream n-3 PUFAs (in days) will be determined with the consideration of sex and rs953413 ELOVL2 polymorphism.
Time frame: Over 12 weeks
Changes in plasma and erythrocyte levels of all fatty acids
Changes in plasma and erythrocyte levels of all fatty acids by sex and rs953413 ELOVL2 polymorphism will be investigated.
Time frame: Baseline and 12 weeks
Changes in plasma δ13C signature of all fatty acids
Changes in plasma δ13C signature (mUr) of all fatty acids with consideration of sex and rs953413 ELOVL2 polymorphism will be investigated.
Time frame: Baseline and 12 weeks
Changes in plasma oxylipin levels
Changes in other oxylipin levels with consideration of sex and rs953413 ELOVL2 polymorphism will be investigated.
Time frame: Baseline, 4 weeks and 12 weeks
Synthesis/turnover rates of EPA and downstream n-3 PUFAs (nmol/ml/day) according to sex and additional genetic polymorphisms
Plasma synthesis/turnover rates of EPA and downstream n-3 PUFAs will be investigated according to the effect of sex and additional genetic polymorphisms (in the FADS gene cluster, ELOVL2, ELOVL5 and ACOX).
Time frame: Day 0, 3, 7, 14, 28, 56, 84
Change in levels of EPA and downstream n-3 PUFAs according to sex and additional genetic polymorphisms
Change from baseline in levels of EPA and downstream n-3 PUFAs will be investigated according to sex and additional genetic polymorphisms (in the FADS gene cluster, ELOVL2, ELOVL5 and ACOX)
Time frame: Baseline and 12 weeks
Plasma synthesis/turnover rates of EPA and downstream n-3 PUFAs (nmol/ml/day) according to blood circulating nutrients and genetic polymorphisms
Plasma synthesis/turnover rates of EPA and downstream n-3 PUFAs (nmol/ml/day) will be investigated according to the interaction of blood circulating nutrients (vitamin B6, nicotinic acid, zinc, iron, magnesium, calcium) and genetic polymorphisms (in FADS gene cluster, ELOVL2 and ELOVL5).
Time frame: Day 0, 3, 7, 14, 28, 56, 84
Change in plasma levels of EPA and downstream n-3 PUFAs according to blood circulating nutrients and genetic polymorphisms
Change from baseline in plasma levels of EPA and downstream n-3 PUFAs will be investigated according to the interaction of blood circulating nutrients (vitamin B6, nicotinic acid, zinc, iron, magnesium, calcium) and genetic polymorphisms (in FADS gene cluster, ELOVL2 and ELOVL5).
Time frame: Baseline and 12 weeks
Adherence
Adherence to supplementation will be assessed by capsule count, change in plasma EPA levels and change in δ13C signature of EPA
Time frame: Baseline and 12 weeks
Changes in blood lipid profile
Changes in lipid profile including triglycerides, LDL, HDL, total cholesterol, and non-HDL (mmol/L) with consideration of sex and rs953413 ELOVL2 polymorphism will be investigated.
Time frame: Baseline and 12 weeks
Changes in office blood pressure (mmHg)
Changes in office systolic and diastolic blood pressure (mmHg) with consideration of sex and rs953413 ELOVL2 polymorphism will be investigated.
Time frame: Day 0, 14, 28, 56, 84
Changes in heart rate (bpm)
Changes in heart rate (bpm) with consideration of sex and rs953413 ELOVL2 polymorphism will be investigated.
Time frame: Day 0, 14, 28, 56, 84
Symptoms Diary
To monitor safety throughout the study, participants will report any unusual symptoms in a symptoms diary. The symptom will be described, along with the date of occurrence and the severity of the symptom on a scale of 1 (low) to 7 (high).
Time frame: Throughout 12 weeks
Dietary intake
Dietary intake in males and females will be assessed by estimated 3 day food record at baseline and days 28, 56 and 84.
Time frame: Day 0, 28, 56, 84
Body mass index (kg/m²)
BMI (kg/m²) will be calculated by the measure of height (metres) and weight (kilograms) throughout the study.
Time frame: Day 0, 28, 56, 84
Body fat percentage
Body fat percentage as measured by bioelectrical impedance will be determined.
Time frame: Day 0, 28, 56, 84
Plan to share: Yes — IPD that resulted in a publication will be shared in a de-identified/anonymized format.
No publications or documents are linked to this record.
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