Cardiometabolic Benefits of Omega-3 Polyunsaturated Fatty Acids (TGIF)

University of Guelph

Status: Completed

Conditions: Cardiovascular Disease

Treatments: Dietary Supplement: High DHA Supplement; Dietary Supplement: High EPA Supplement; Dietary Supplement: Placebo Olive Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT03378232

The Goodness In Fish Oil

Details and patient eligibility

About

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.

Full 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

Enrollment: 90 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

Placebo Olive Oil

Placebo Comparator group

Description:

Placebo supplement with olive oil

Treatment:

Dietary Supplement: Placebo Olive Oil

High EPA Supplement

Experimental group

Description:

Supplements providing up to 3g per day of Omega-3, with increased EPA

Treatment:

Dietary Supplement: High EPA Supplement

High DHA Supplement

Experimental group

Description:

Supplements providing up to 3g per day of Omega-3, with increased DHA

Treatment:

Dietary Supplement: High DHA Supplement