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

February 16, 2018 updated by: David M Mutch, University of Guelph

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
CHANGE from Baseline at 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Guelph

Collaborators

Ontario Ministry of Agriculture, Food and Rural Affairs

Investigators

  • Principal Investigator: David M Mutch, PhD, University of Guelph
  • Principal Investigator: Phillip Millar, PhD, University of Guelph
  • Principal Investigator: Lawrence Spriet, PhD, University of Guelph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2017

Primary Completion (Actual)

May 26, 2017

Study Completion (Actual)

May 30, 2017

Study Registration Dates

First Submitted

December 12, 2017

First Submitted That Met QC Criteria

December 17, 2017

First Posted (Actual)

December 19, 2017

Study Record Updates

Last Update Posted (Actual)

February 20, 2018

Last Update Submitted That Met QC Criteria

February 16, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The Goodness In Fish Oil

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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