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OpenTrials
Completed

NCT Number: NCT03378232

Cardiometabolic Benefits of Omega-3 Polyunsaturated Fatty Acids

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo Olive Oil

Dietary Supplement

Each participant was instructed to consume the dietary supplement on a daily basis for 12 weeks.

High EPA Supplement

Dietary Supplement

Each participant was instructed to consume assigned dietary supplement on a daily basis for 12 weeks.

High DHA Supplement

Dietary Supplement

Each participant was instructed to consume assigned dietary supplement on a daily basis for 12 weeks.

Primary outcomes

  1. Omega-3 Index

    Time frame: CHANGE from Baseline at 12 weeks

    Omega-3 Index, as determined by measuring omega-3 fats in red blood cells using gas chromatography

Secondary outcomes

  1. Triglycerides

    Time frame: CHANGE from Baseline at 12 weeks

    Fasted serum triglycerides (mmol/L)

  2. High-sensitivity C-Reactive Protein (hs-CRP)

    Time frame: CHANGE from Baseline at 12 weeks

    Blood hs-CRP levels

  3. Energy Expenditure

    Time frame: CHANGE from Baseline at 12 weeks

    Resting Metabolic Rate

  4. Blood Pressure

    Time frame: CHANGE from Baseline at 12 weeks

    Both systolic and diastolic blood pressure will be assessed

  5. Muscle sympathetic nerve activity (MSNA)

    Time frame: Change from Baseline at 12 weeks

    Fibular nerve microneurography

Sponsors and collaborators

Lead sponsor

University of Guelph

Other

Collaborators

  • Ontario Ministry of Agriculture, Food and Rural Affairs

Registry information

Official study title

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

Acronym: TGIF

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 19, 2017
Registry last updated
Feb 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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