NCT06975241 Observing Metabolism of EPA With Consideration of Genetics And Sex
| NCT ID | NCT06975241 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Toronto |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2025-07-29 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 64 participants in total. It began in 2025-07-29 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT06975241 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 35 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06975241 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06975241 currently recruiting?
Yes, NCT06975241 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Toronto to inquire about joining.
Where is the NCT06975241 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06975241 clinical trial?
NCT06975241 is sponsored by University of Toronto. The trial plans to enroll 64 participants.