HealthyPhase 4OMEGANCT06975241
Observing Metabolism of EPA With Consideration of Genetics And Sex
A Phase 4 study testing EPA 2.4g/day in people with Healthy and Omega 3, run by University of Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Omega 3, Metabolism, Lipids
- What is being tested?
- EPA 2.4g/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jul 2025to Sep 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 18.5- 30 kg/m2
- healthy
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Clinical Nutrition and Risk Factor Modification Centre
Toronto, Ontario, M5C 2T2
Study Coordinator, 4168677487, dandan.li2@unityhealth.to
About this study
Official title: Determining Contribution of Sex and Genetics to DHA Synthesis Rates Over 12 Weeks of EPA Supplementation in Healthy Individuals
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:
Read more
- 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
- Being tested
- EPA 2.4g/day
- Keywords
- eicosapentaenoic acid, omega-3 polyunsaturated fatty acids, lipid metabolism, healthy adults, docosahexaenoic acid, single nucleotide polymorphism, elongation of very long-chain 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPA 2.4g/dayDietary supplement
EPA from fish oil will be supplemented to an equal number of males and females for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: EPA 2.4g/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0, 3, 7, 14, 28, 56, 84
Secondary outcomes (5)
Changes in plasma DHA concentrations (nmol/ml)
Changes in plasma DHA concentrations by sex and rs953413 ELOVL2 polymorphism will be determined.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Over 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start29 Jul 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Metherel, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975241
- Sponsor's protocol ID
- 00048186
- Acronym
- OMEGA
- Status last verified
- Feb 2026
- First submitted
- 29 Apr 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that resulted in a publication will be shared in a de-identified/anonymized format.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Contribution of Sex and Genetics to DHA Synthesis Rates Over 12 Weeks of EPA Supplementation in Healthy Individuals
- ClinicalTrials.gov ID
- NCT06975241
- Acronym / sponsor ID
- OMEGA / 00048186
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EPA Supplementation | Experimental | Dietary Supplement: EPA 2.4g/day32 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI between 18.5- 30 kg/m2
- healthy
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPA 2.4g/dayEPA from fish oil will be supplemented to an equal number of males and females for 12 weeks. | Dietary supplement | EPA Supplementation |
Primary outcome
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.
5 secondary outcomes
Changes in plasma DHA concentrations (nmol/ml)
Time frame: Baseline and 12 weeks
Plasma EPA turnover rates (nmol/ml/day)
Time frame: Day 0, 3, 7, 14, 28, 56, 84
Plasma DPAn-3 synthesis/turnover rates (nmol/ml/day)
Time frame: Day 0, 3, 7, 14, 28, 56, 84
Changes in PUFA derived eicosanoid/docosanoid levels
Time frame: Baseline, 4 weeks and 12 weeks
Plasma half-lives of EPA and downstream n-3 PUFAs
Time frame: Over 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Yes. IPD that resulted in a publication will be shared in a de-identified/anonymized format.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Nutrition and Risk Factor Modification Centre
Toronto, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EPA 2.4g/day in people with Healthy and Omega 3, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma DHA synthesis/turnover rates (time frame: Day 0, 3, 7, 14, 28, 56, 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.