Observing Metabolism of EPA With Consideration of Genetics And Sex

NCT06975241 | Recruiting Phase 4

• 1 other identifier: 00048186
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Omega 3; Metabolism, Lipids

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0, 3, 7, 14, 28, 56, 84

Secondary Outcomes (5)

• Changes in plasma DHA concentrations (nmol/ml)

  Baseline and 12 weeks

• Plasma EPA turnover rates (nmol/ml/day)

  Day 0, 3, 7, 14, 28, 56, 84

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

  Day 0, 3, 7, 14, 28, 56, 84

• Changes in PUFA derived eicosanoid/docosanoid levels

  Baseline, 4 weeks and 12 weeks

• Plasma half-lives of EPA and downstream n-3 PUFAs

  Over 12 weeks

Other Outcomes (15)

• Changes in plasma and erythrocyte levels of all fatty acids

  Baseline and 12 weeks

• Changes in plasma δ13C signature of all fatty acids

  Baseline and 12 weeks

• Changes in plasma oxylipin levels

  Baseline, 4 weeks and 12 weeks

Study Arms (1)

EPA Supplementation

EXPERIMENTAL

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

Interventions

EPA 2.4g/day DIETARY_SUPPLEMENT

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

EPA Supplementation

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI between 18.5- 30 kg/m2
• healthy

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Clinical Nutrition and Risk Factor Modification Centre

Toronto, Ontario, M5C 2T2, Canada

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 16, 2025
• Study Start: July 29, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 1 year after publication of the data with no end date.
• Access Criteria: IPD will be accessible through University of Toronto dataverse (https://borealisdata.ca/dataverse/toronto). The metadata record will be public but access to the dataset will be restricted. Users will need to request access to view and download the dataset.

Locations

CA (1)