Observing Metabolism of EPA With Consideration of Genetics And Sex

NCT ID: NCT06975241

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2026-09-30

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.

Conditions

Healthy; Omega 3; Metabolism, Lipids

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

EPA Supplementation

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.

Group Type: EXPERIMENTAL

EPA 2.4g/day

Intervention Type: DIETARY_SUPPLEMENT

EPA from fish oil will be supplemented to an equal number of males and females for 12 weeks.

Interventions

EPA 2.4g/day

EPA from fish oil will be supplemented to an equal number of males and females for 12 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

Adam Metherel

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinical Nutrition and Risk Factor Modification Centre

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Facility Contacts

Study Coordinator

Role: primary

dandan.li2@unityhealth.to

4168677487

Other Identifiers

00048186

Identifier Type: -

Identifier Source: org_study_id