Cardiometabolic Benefits of Omega-3 Polyunsaturated Fatty Acids

Study Overview
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Brief Summary
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Omega 3 fatty acids have been shown to provide a number of cardiometabolic benefits in both healthy and at risk populations. Specifically, the daily consumption of fish oil supplements has been reported to reduce blood triglyceride levels, and influence glucose homeostasis and whole-body inflammation. Furthermore, a number of cardiovascular effects (i.e. reduced blood pressure, reduced coagulation) have been found to result from omega-3 consumption, as well as influencing energy expenditure (i.e. resting metabolic rate). The goal of this study is to examine the cardiometabolic and cardiovascular effects that result from long-term consumption of omega-3 fatty acids.

Detailed Description
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Cardiovascular disease (CVD) and type 2 diabetes (T2D) are major contributors to healthcare costs in Canada. A cluster of cardiometabolic risk factors including insulin resistance, dyslipidemia, hypertension, and abdominal obesity increases the risk of developing the aforementioned diseases. While drugs can help to treat or slow the development of cardiometabolic problems, they are not always effective and in some instances can have adverse effects on a patient's health. In comparison, changing, modifying or improving dietary habits is now recognized as a safe and effective way to help reduce the risk of developing CVD, as well as treat CVD and T2D. The consumption of omega-3 fatty acids (FAs) is highly recommended due to their known benefits for health and development; however, considerable variability exists in the literature regarding the benefits of omega-3 FAs. This variability stems from differences in study design; differing in dosage, duration of supplementation, population studied, sample size, as well as the amounts of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) used in supplements. The current study will investigate the effects of EPA and DHA on markers of cardiometabolic and cardiovascular health in young adults. To assess the effectiveness of EPA and DHA on markers of cardiometabolic health, including blood lipids, such as triglycerides, total cholesterol, high-density lipoprotein (HDL) and low-density lipoprotein (LDL) levels markers of inflammation, such as high-sensitivity C-reactive protein (hs-CRP) and other circulating cytokines whole-body glucose and insulin levels resting metabolic rate blood pressure and muscle sympathetic nerve activity

Official Title
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EPA and DHA Regulation of Blood Triglycerides, Resting Metabolic Rate and Blood Markers of Cardiometabolic Health.

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Dietary Supplement: Placebo Olive Oil
* Dietary Supplement: High EPA Supplement
* Dietary Supplement: High DHA Supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between the ages of 18-30 years Healthy Exclusion Criteria: Younger than 18 years Older than 30 years Allergic to fish and/or shellfish or gelatin High consumption of omega-3 fats (either fatty fish or dietary supplements) Chronic or communicable diseases Anticipated change in lifestyle (moving to a new house, starting a new fitness routine). Discomfort giving blood Use of lipid-controlling medication, including cholesterol lowering drugs (statins), fatty acid/triglyceride altering (fibrates) or any other drug known to have lipid altering effects, such as ezetimibe, colesevelam, torcetrapib, avasimibe, and implitapide Chronic use of anti-inflammatory medications Pregnant, or is planning to become pregnant during the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Olive Oil<br>Placebo supplement with olive oil | Dietary Supplement: Placebo Olive Oil<br>* Each participant was instructed to consume the dietary supplement on a daily basis for 12 weeks.<br>|
| Experimental: High EPA Supplement<br>Supplements providing up to 3g per day of Omega-3, with increased EPA | Dietary Supplement: High EPA Supplement<br>* Each participant was instructed to consume assigned dietary supplement on a daily basis for 12 weeks.<br>|
| Experimental: High DHA Supplement<br>Supplements providing up to 3g per day of Omega-3, with increased DHA | Dietary Supplement: High DHA Supplement<br>* Each participant was instructed to consume assigned dietary supplement on a daily basis for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Omega-3 Index | Omega-3 Index, as determined by measuring omega-3 fats in red blood cells using gas chromatography | CHANGE from Baseline at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglycerides | Fasted serum triglycerides (mmol/L) | CHANGE from Baseline at 12 weeks | 
| High-sensitivity C-Reactive Protein (hs-CRP) | Blood hs-CRP levels | CHANGE from Baseline at 12 weeks | 
| Energy Expenditure | Resting Metabolic Rate | CHANGE from Baseline at 12 weeks | 
| Blood Pressure | Both systolic and diastolic blood pressure will be assessed | CHANGE from Baseline at 12 weeks | 
| Muscle sympathetic nerve activity (MSNA) | Fibular nerve microneurography | Change from Baseline at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DHA, EPA, fatty acids, blood pressure, resting metabolic rate, blood lipids, muscle sympathetic nerve activity (MSNA)