Observing Metabolism of EPA With Consideration of Genetics And Sex
- Conditions
- HealthyOmega 3Metabolism, Lipids
- Registration Number
- NCT06975241
- Lead Sponsor
- University of Toronto
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 64
- BMI between 18.5- 30 kg/m2
- healthy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Plasma DHA synthesis/turnover rates 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.
- Secondary Outcome Measures
Name Time Method Changes in plasma DHA concentrations (nmol/ml) Baseline and 12 weeks Changes 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, 84 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.
Plasma half-lives of EPA and downstream n-3 PUFAs Over 12 weeks Plasma half-lives of EPA and downstream n-3 PUFAs (in days) will be determined with the consideration of sex and rs953413 ELOVL2 polymorphism.
Plasma DPAn-3 synthesis/turnover rates (nmol/ml/day) Day 0, 3, 7, 14, 28, 56, 84 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.
Changes in PUFA derived eicosanoid/docosanoid levels Baseline, 4 weeks and 12 weeks Changes in n-3 and n-6 PUFA derived eicosanoid/docosanoid levels by sex and rs953413 ELOVL2 polymorphism will be investigated.
Trial Locations
- Locations (1)
Clinical Nutrition and Risk Factor Modification Centre
🇨🇦Toronto, Ontario, Canada