Observing Metabolism of EPA With Consideration of Genetics And Sex (OMEGA)

University of Toronto

Status and phase: Enrolling; Phase 4

Conditions: Healthy; Omega 3; Metabolism, Lipids

Treatments: Dietary Supplement: EPA 2.4g/day

Study type: Interventional

Funder types: Other

Identifiers

NCT06975241

00048186

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

64 participants in 1 patient group

EPA Supplementation

Experimental group

Description:

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.

Treatment:

Dietary Supplement: EPA 2.4g/day