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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:
Participants will be asked to take EPA supplements for 12 weeks and provide a series of venous blood samples over the study duration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPA Supplementation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPA 2.4g/day | Dietary Supplement | EPA from fish oil will be supplemented to an equal number of males and females for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0, 3, 7, 14, 28, 56, 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in plasma DHA concentrations (nmol/ml) | Changes in plasma DHA concentrations by sex and rs953413 ELOVL2 polymorphism will be determined. | Baseline and 12 weeks |
| Plasma EPA turnover rates (nmol/ml/day) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 weeks |
| Changes in plasma δ13C signature of all fatty acids |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Nutrition and Risk Factor Modification Centre | Recruiting | Toronto | Ontario | M5C 2T2 | Canada |
IPD that resulted in a publication will be shared in a de-identified/anonymized format.
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Beginning 1 year after publication of the data with no end date.
IPD will be accessible through University of Toronto dataverse (https://borealisdata.ca/dataverse/toronto). The metadata record will be public but access to the dataset will be restricted. Users will need to request access to view and download the dataset.
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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.
| 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. | 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. | 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. | Over 12 weeks |
Changes in plasma δ13C signature (mUr) of all fatty acids with consideration of sex and rs953413 ELOVL2 polymorphism will be investigated.
| Baseline and 12 weeks |
| Changes in plasma oxylipin levels | Changes in other oxylipin levels with consideration of sex and rs953413 ELOVL2 polymorphism will be investigated. | Baseline, 4 weeks and 12 weeks |
| 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). | Day 0, 3, 7, 14, 28, 56, 84 |
| Change in levels of EPA and downstream n-3 PUFAs according to sex and additional genetic polymorphisms | Change from baseline in levels of EPA and downstream n-3 PUFAs will be investigated according to sex and additional genetic polymorphisms (in the FADS gene cluster, ELOVL2, ELOVL5 and ACOX) | Baseline and 12 weeks |
| Plasma synthesis/turnover rates of EPA and downstream n-3 PUFAs (nmol/ml/day) according to blood circulating nutrients and genetic polymorphisms | Plasma synthesis/turnover rates of EPA and downstream n-3 PUFAs (nmol/ml/day) will be investigated according to the interaction of blood circulating nutrients (vitamin B6, nicotinic acid, zinc, iron, magnesium, calcium) and genetic polymorphisms (in FADS gene cluster, ELOVL2 and ELOVL5). | Day 0, 3, 7, 14, 28, 56, 84 |
| Change in plasma levels of EPA and downstream n-3 PUFAs according to blood circulating nutrients and genetic polymorphisms | Change from baseline in plasma levels of EPA and downstream n-3 PUFAs will be investigated according to the interaction of blood circulating nutrients (vitamin B6, nicotinic acid, zinc, iron, magnesium, calcium) and genetic polymorphisms (in FADS gene cluster, ELOVL2 and ELOVL5). | Baseline and 12 weeks |
| Adherence | Adherence to supplementation will be assessed by capsule count, change in plasma EPA levels and change in δ13C signature of EPA | Baseline and 12 weeks |
| Changes in blood lipid profile | Changes in lipid profile including triglycerides, LDL, HDL, total cholesterol, and non-HDL (mmol/L) with consideration of sex and rs953413 ELOVL2 polymorphism will be investigated. | Baseline and 12 weeks |
| Changes in office blood pressure (mmHg) | Changes in office systolic and diastolic blood pressure (mmHg) with consideration of sex and rs953413 ELOVL2 polymorphism will be investigated. | Day 0, 14, 28, 56, 84 |
| Changes in heart rate (bpm) | Changes in heart rate (bpm) with consideration of sex and rs953413 ELOVL2 polymorphism will be investigated. | Day 0, 14, 28, 56, 84 |
| Symptoms Diary | To monitor safety throughout the study, participants will report any unusual symptoms in a symptoms diary. The symptom will be described, along with the date of occurrence and the severity of the symptom on a scale of 1 (low) to 7 (high). | Throughout 12 weeks |
| Dietary intake | Dietary intake in males and females will be assessed by estimated 3 day food record at baseline and days 28, 56 and 84. | Day 0, 28, 56, 84 |
| Body mass index (kg/m²) | BMI (kg/m²) will be calculated by the measure of height (metres) and weight (kilograms) throughout the study. | Day 0, 28, 56, 84 |
| Body fat percentage | Body fat percentage as measured by bioelectrical impedance will be determined. | Day 0, 28, 56, 84 |