Clinical trial NCT06975241: Observing Metabolism of EPA With Consideration of Genetics And Sex
Official title: Determining Contribution of Sex and Genetics to DHA Synthesis Rates Over 12 Weeks of EPA Supplementation in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Healthy
Omega 3
Metabolism, Lipids
Keywords: eicosapentaenoic acid
omega-3 polyunsaturated fatty acids
lipid metabolism
healthy adults
docosahexaenoic acid
single nucleotide polymorphism
elongation of very long-chain 2
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Plasma DHA synthesis/turnover rates
timeFrame: Day 0, 3, 7, 14, 28, 56, 84
Secondary outcomes:
measure: Changes in plasma DHA concentrations (nmol/ml)
timeFrame: Baseline and 12 weeks
measure: Plasma EPA turnover rates (nmol/ml/day)
timeFrame: Day 0, 3, 7, 14, 28, 56, 84
measure: Plasma DPAn-3 synthesis/turnover rates (nmol/ml/day)
timeFrame: Day 0, 3, 7, 14, 28, 56, 84
measure: Changes in PUFA derived eicosanoid/docosanoid levels
timeFrame: Baseline, 4 weeks and 12 weeks
measure: Plasma half-lives of EPA and downstream n-3 PUFAs
timeFrame: Over 12 weeks
Other outcomes:
measure: Changes in plasma and erythrocyte levels of all fatty acids
timeFrame: Baseline and 12 weeks
measure: Changes in plasma δ13C signature of all fatty acids
timeFrame: Baseline and 12 weeks
measure: Changes in plasma oxylipin levels
timeFrame: Baseline, 4 weeks and 12 weeks
measure: Synthesis/turnover rates of EPA and downstream n-3 PUFAs (nmol/ml/day) according to sex and additional genetic polymorphisms
timeFrame: Day 0, 3, 7, 14, 28, 56, 84
measure: Change in levels of EPA and downstream n-3 PUFAs according to sex and additional genetic polymorphisms
timeFrame: Baseline and 12 weeks
measure: Plasma synthesis/turnover rates of EPA and downstream n-3 PUFAs (nmol/ml/day) according to blood circulating nutrients and genetic polymorphisms
timeFrame: Day 0, 3, 7, 14, 28, 56, 84
measure: Change in plasma levels of EPA and downstream n-3 PUFAs according to blood circulating nutrients and genetic polymorphisms
timeFrame: Baseline and 12 weeks
measure: Adherence
timeFrame: Baseline and 12 weeks
measure: Changes in blood lipid profile
timeFrame: Baseline and 12 weeks
measure: Changes in office blood pressure (mmHg)
timeFrame: Day 0, 14, 28, 56, 84
measure: Changes in heart rate (bpm)
timeFrame: Day 0, 14, 28, 56, 84
measure: Symptoms Diary
timeFrame: Throughout 12 weeks
measure: Dietary intake
timeFrame: Day 0, 28, 56, 84
measure: Body mass index (kg/m²)
timeFrame: Day 0, 28, 56, 84
measure: Body fat percentage
timeFrame: Day 0, 28, 56, 84
Locations:
city: Toronto
country: Canada
facility: Clinical Nutrition and Risk Factor Modification Centre
state: Ontario
Study officials:
References: