Status:
RECRUITING
Observing Metabolism of EPA With Consideration of Genetics And Sex
Lead Sponsor:
University of Toronto
Conditions:
Healthy
Omega 3
Eligibility:
All Genders
18-35 years
Phase:
PHASE4
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 aim...
Eligibility Criteria
Inclusion
- BMI between 18.5- 30 kg/m2
- healthy
Exclusion
- High consumption of n-3 PUFA, including ≥ 2 servings of fish/seafood or EPA/DHA-enriched foods per week
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06975241
Start Date
May 1 2025
End Date
September 1 2026
Last Update
May 16 2025
Active Locations (1)
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1
Clinical Nutrition and Risk Factor Modification Centre
Toronto, Ontario, Canada, M5C 2T2