Observing Metabolism of EPA With Consideration of Genetics And Sex
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-35
SponsorUniversity of Toronto
About this trial
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
This trial accepts healthy volunteersQualifiers
BMI between 18.5- 30 kg/m2
healthy
Disqualifiers
Consumption of fish/seafood or EPA/DHA-enriched foods currently or within the previous 6 months
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
Trial design
Design model
Single group
Treatments tested in this trial
EPA 2.4g/day
Dietary supplementEPA from fish oil will be supplemented to an equal number of males and females for 12 weeks.
Treatment groups
64 Participants
are divided into 1 treatment groupGroup A: EPA SupplementationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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, 84Secondary outcomes
1
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 weeks2
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, 843
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, 844
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 weeksOther outcomes
1
Changes in plasma and erythrocyte levels of all fatty acids
Changes in plasma and erythrocyte levels of all fatty acids by sex and rs953413 ELOVL2 polymorphism will be investigated.
Time frame
Baseline and 12 weeks2
Changes in plasma δ13C signature of all fatty acids
Changes in plasma δ13C signature (mUr) of all fatty acids with consideration of sex and rs953413 ELOVL2 polymorphism will be investigated.
Time frame
Baseline and 12 weeks3
Changes in plasma oxylipin levels
Changes in other oxylipin levels with consideration of sex and rs953413 ELOVL2 polymorphism will be investigated.
Time frame
Baseline, 4 weeks and 12 weeks4
Synthesis/turnover rates of EPA and downstream n-3 PUFAs (nmol/ml/day) according to sex and additional genetic polymorphisms
Plasma synthesis/turnover rates of EPA and downstream n-3 PUFAs will be investigated according to the effect of sex and additional genetic polymorphisms (in the FADS gene cluster, ELOVL2, ELOVL5 and ACOX).
Time frame
Day 0, 3, 7, 14, 28, 56, 84Sponsors and contacts
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Source ClinicalTrials.gov