Observing Metabolism of EPA With Consideration of Genetics And Sex

Phase 4RecruitingNCT06975241

University of Toronto64 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Omega 3 Metabolism, Lipids

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * BMI between 18.5- 30 kg/m2 * healthy Exclusion Criteria: * 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

Outcomes

Primary Outcomes

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.

Time frame: Day 0, 3, 7, 14, 28, 56, 84

Secondary Outcomes

Changes in plasma DHA concentrations (nmol/ml)

Changes in plasma DHA concentrations by sex and rs953413 ELOVL2 polymorphism will be determined.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Over 12 weeks

Observing Metabolism of EPA With Consideration of Genetics And Sex

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes