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NCT Number: NCT06975241

Observing Metabolism of EPA With Consideration of Genetics And Sex

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.

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Key information

Conditions

Healthy Metabolism, Lipids Omega 3

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinical Nutrition and Risk Factor Modification Centre

Toronto, Ontario, M5C 2T2, Canada

Location status: Recruiting

Location contact

Study Coordinator

CONTACT

[email protected]

4168677487

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EPA 2.4g/day

Dietary Supplement

EPA from fish oil will be supplemented to an equal number of males and females for 12 weeks.

Primary outcomes

  1. Plasma DHA synthesis/turnover rates

    Time frame: Day 0, 3, 7, 14, 28, 56, 84

    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.

Secondary outcomes

  1. Changes in plasma DHA concentrations (nmol/ml)

    Time frame: Baseline and 12 weeks

    Changes in plasma DHA concentrations by sex and rs953413 ELOVL2 polymorphism will be determined.

  2. Plasma EPA turnover rates (nmol/ml/day)

    Time frame: Day 0, 3, 7, 14, 28, 56, 84

    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.

  3. Plasma DPAn-3 synthesis/turnover rates (nmol/ml/day)

    Time frame: Day 0, 3, 7, 14, 28, 56, 84

    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.

  4. Changes in PUFA derived eicosanoid/docosanoid levels

    Time frame: Baseline, 4 weeks and 12 weeks

    Changes in n-3 and n-6 PUFA derived eicosanoid/docosanoid levels by sex and rs953413 ELOVL2 polymorphism will be investigated.

  5. Plasma half-lives of EPA and downstream n-3 PUFAs

    Time frame: Over 12 weeks

    Plasma half-lives of EPA and downstream n-3 PUFAs (in days) will be determined with the consideration of sex and rs953413 ELOVL2 polymorphism.

Other outcomes

  1. Changes in plasma and erythrocyte levels of all fatty acids

    Time frame: Baseline and 12 weeks

    Changes in plasma and erythrocyte levels of all fatty acids by sex and rs953413 ELOVL2 polymorphism will be investigated.

  2. Changes in plasma δ13C signature of all fatty acids

    Time frame: Baseline and 12 weeks

    Changes in plasma δ13C signature (mUr) of all fatty acids with consideration of sex and rs953413 ELOVL2 polymorphism will be investigated.

  3. Changes in plasma oxylipin levels

    Time frame: Baseline, 4 weeks and 12 weeks

    Changes in other oxylipin levels with consideration of sex and rs953413 ELOVL2 polymorphism will be investigated.

  4. Synthesis/turnover rates of EPA and downstream n-3 PUFAs (nmol/ml/day) according to sex and additional genetic polymorphisms

    Time frame: Day 0, 3, 7, 14, 28, 56, 84

    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).

  5. Change in levels of EPA and downstream n-3 PUFAs according to sex and additional genetic polymorphisms

    Time frame: Baseline and 12 weeks

    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)

  6. Plasma synthesis/turnover rates of EPA and downstream n-3 PUFAs (nmol/ml/day) according to blood circulating nutrients and genetic polymorphisms

    Time frame: Day 0, 3, 7, 14, 28, 56, 84

    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).

  7. Change in plasma levels of EPA and downstream n-3 PUFAs according to blood circulating nutrients and genetic polymorphisms

    Time frame: Baseline and 12 weeks

    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).

  8. Adherence

    Time frame: Baseline and 12 weeks

    Adherence to supplementation will be assessed by capsule count, change in plasma EPA levels and change in δ13C signature of EPA

  9. Changes in blood lipid profile

    Time frame: Baseline and 12 weeks

    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.

  10. Changes in office blood pressure (mmHg)

    Time frame: Day 0, 14, 28, 56, 84

    Changes in office systolic and diastolic blood pressure (mmHg) with consideration of sex and rs953413 ELOVL2 polymorphism will be investigated.

  11. Changes in heart rate (bpm)

    Time frame: Day 0, 14, 28, 56, 84

    Changes in heart rate (bpm) with consideration of sex and rs953413 ELOVL2 polymorphism will be investigated.

  12. Symptoms Diary

    Time frame: Throughout 12 weeks

    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).

  13. Dietary intake

    Time frame: Day 0, 28, 56, 84

    Dietary intake in males and females will be assessed by estimated 3 day food record at baseline and days 28, 56 and 84.

  14. Body mass index (kg/m²)

    Time frame: Day 0, 28, 56, 84

    BMI (kg/m²) will be calculated by the measure of height (metres) and weight (kilograms) throughout the study.

  15. Body fat percentage

    Time frame: Day 0, 28, 56, 84

    Body fat percentage as measured by bioelectrical impedance will be determined.

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Registry information

Official study title

Determining Contribution of Sex and Genetics to DHA Synthesis Rates Over 12 Weeks of EPA Supplementation in Healthy Individuals

Acronym: OMEGA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 16, 2025
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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