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Observing Metabolism of EPA With Consideration of Genetics And Sex

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06975241
Acronym
OMEGA
Enrollment
64
Registered
2025-05-16
Start date
2025-07-29
Completion date
2026-09-01
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Metabolism, Lipids, Omega 3

Keywords

eicosapentaenoic acid, omega-3 polyunsaturated fatty acids, lipid metabolism, healthy adults, docosahexaenoic acid, single nucleotide polymorphism, elongation of very long-chain 2

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.

Interventions

DIETARY_SUPPLEMENTEPA 2.4g/day

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

Sponsors

University of Toronto
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Plasma DHA synthesis/turnover ratesDay 0, 3, 7, 14, 28, 56, 84Plasma 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

MeasureTime frameDescription
Changes in plasma DHA concentrations (nmol/ml)Baseline and 12 weeksChanges in plasma DHA concentrations by sex and rs953413 ELOVL2 polymorphism will be determined.
Plasma EPA turnover rates (nmol/ml/day)Day 0, 3, 7, 14, 28, 56, 84Plasma 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.
Plasma DPAn-3 synthesis/turnover rates (nmol/ml/day)Day 0, 3, 7, 14, 28, 56, 84Plasma 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.
Changes in PUFA derived eicosanoid/docosanoid levelsBaseline, 4 weeks and 12 weeksChanges in n-3 and n-6 PUFA derived eicosanoid/docosanoid levels by sex and rs953413 ELOVL2 polymorphism will be investigated.
Plasma half-lives of EPA and downstream n-3 PUFAsOver 12 weeksPlasma half-lives of EPA and downstream n-3 PUFAs (in days) will be determined with the consideration of sex and rs953413 ELOVL2 polymorphism.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026