Cardiometabolic Benefits of Omega-3 Polyunsaturated Fatty Acids

Not Applicable

Completed

• Conditions: Cardiovascular Disease
• Interventions: Dietary Supplement: High EPA Supplement; Dietary Supplement: Placebo Olive Oil; Dietary Supplement: High DHA Supplement

• Registration Number: NCT03378232
• Lead Sponsor: University of Guelph

Brief Summary

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

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

1. blood lipids, such as triglycerides, total cholesterol, high-density lipoprotein (HDL) and low-density lipoprotein (LDL) levels

2. markers of inflammation, such as high-sensitivity C-reactive protein (hs-CRP) and other circulating cytokines

3. whole-body glucose and insulin levels

4. resting metabolic rate

5. blood pressure and muscle sympathetic nerve activity

Study Timeline

• Study Start: 2017-01-05
• Primary Completion: 2017-05-26
• Study Completion: 2017-05-30
• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-17
• Study First Posted: 2017-12-19
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-16
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High EPA Supplement	High EPA Supplement	Supplements providing up to 3g per day of Omega-3, with increased EPA
Placebo Olive Oil	Placebo Olive Oil	Placebo supplement with olive oil
High DHA Supplement	High DHA Supplement	Supplements providing up to 3g per day of Omega-3, with increased DHA

Primary Outcome Measures

Name	Time	Method
Omega-3 Index	CHANGE from Baseline at 12 weeks	Omega-3 Index, as determined by measuring omega-3 fats in red blood cells using gas chromatography

Secondary Outcome Measures

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