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AzTrials

Cardiovascular DiseaseTGIFNCT03378232

Cardiometabolic Benefits of Omega-3 Polyunsaturated Fatty Acids

A study testing High EPA Supplement and High DHA Supplement in people with Cardiovascular Disease, run by University of Guelph.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Disease
What is being tested?
High EPA Supplement and High DHA Supplement
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
No sites listed yet
Study dates
5 Jan 2017to 30 May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Between the ages of 18-30 years
  • Healthy

Who cannot join

  • 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).
Show all 10Show fewer
  • 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

About this study

Official title: 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.

Read the 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
Being tested
Placebo Olive Oil, High EPA Supplement, High DHA Supplement
Keywords
DHA, EPA, fatty acids, blood pressure, resting metabolic rate, blood lipids, muscle sympathetic nerve activity (MSNA)
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo Olive OilDietary supplement

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

  • High EPA SupplementDietary supplement

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

  • High DHA SupplementDietary supplement

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

Study groups in NCT03378232
Study groupRoleWhat they receive
Placebo Olive OilPlacebo comparatorPlacebo supplement with olive oil
Receives: Dietary Supplement: Placebo Olive Oil
High EPA SupplementExperimentalSupplements providing up to 3g per day of Omega-3, with increased EPA
Receives: Dietary Supplement: High EPA Supplement
High DHA SupplementExperimentalSupplements providing up to 3g per day of Omega-3, with increased DHA
Receives: Dietary Supplement: High DHA Supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Omega-3 Index

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

    Measured: CHANGE from Baseline at 12 weeks

Secondary outcomes (5)

  1. Triglycerides

    Fasted serum triglycerides (mmol/L)

    Measured: CHANGE from Baseline at 12 weeks

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

    Blood hs-CRP levels

    Measured: CHANGE from Baseline at 12 weeks

  3. Energy Expenditure

    Resting Metabolic Rate

    Measured: CHANGE from Baseline at 12 weeks

  4. Blood Pressure

    Both systolic and diastolic blood pressure will be assessed

    Measured: CHANGE from Baseline at 12 weeks

  5. Muscle sympathetic nerve activity (MSNA)

    Fibular nerve microneurography

    Measured: Change from Baseline at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2017
  2. Study start5 Jan 2017
  3. Primary completion26 May 2017
  4. Study completion30 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03378232
Sponsor's protocol ID
The Goodness In Fish Oil
Acronym
TGIF
Status last verified
Feb 2018
First submitted
12 Dec 2017
Last updated
20 Feb 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Roke K, Mutch DM. The role of FADS1/2 polymorphisms on cardiometabolic markers and fatty acid profiles in young adults consuming fish oil supplements. Nutrients. 2014 Jun 16;6(6):2290-304. doi: 10.3390/nu6062290.

    PubMed 24936800

  • Roke K, Jannas-Vela S, Spriet LL, Mutch DM. FADS2 genotype influences whole-body resting fat oxidation in young adult men. Appl Physiol Nutr Metab. 2016 Jul;41(7):791-4. doi: 10.1139/apnm-2016-0043. Epub 2016 Mar 16.

    PubMed 27144909

  • Miller PE, Van Elswyk M, Alexander DD. Long-chain omega-3 fatty acids eicosapentaenoic acid and docosahexaenoic acid and blood pressure: a meta-analysis of randomized controlled trials. Am J Hypertens. 2014 Jul;27(7):885-96. doi: 10.1093/ajh/hpu024. Epub 2014 Mar 6.

    PubMed 24610882

  • Merino DM, Ma DW, Mutch DM. Genetic variation in lipid desaturases and its impact on the development of human disease. Lipids Health Dis. 2010 Jun 18;9:63. doi: 10.1186/1476-511X-9-63.

    PubMed 20565855

  • Klingel SL, Roke K, Hidalgo B, Aslibekyan S, Straka RJ, An P, Province MA, Hopkins PN, Arnett DK, Ordovas JM, Lai CQ, Mutch DM. Sex Differences in Blood HDL-c, the Total Cholesterol/HDL-c Ratio, and Palmitoleic Acid are Not Associated with Variants in Common Candidate Genes. Lipids. 2017 Dec;52(12):969-980. doi: 10.1007/s11745-017-4307-5. Epub 2017 Oct 27.

    PubMed 29080057

  • Metherel AH, Valenzuela R, Klievik BJ, Cisbani G, Rotarescu RD, Gonzalez-Soto M, Cruciani-Guglielmacci C, Laye S, Magnan C, Mutch DM, Bazinet RP. Dietary docosahexaenoic acid (DHA) downregulates liver DHA synthesis by inhibiting eicosapentaenoic acid elongation. J Lipid Res. 2024 Jun;65(6):100548. doi: 10.1016/j.jlr.2024.100548. Epub 2024 Apr 20.

    PubMed 38649096

  • Klingel SL, Metherel AH, Irfan M, Rajna A, Chabowski A, Bazinet RP, Mutch DM. EPA and DHA have divergent effects on serum triglycerides and lipogenesis, but similar effects on lipoprotein lipase activity: a randomized controlled trial. Am J Clin Nutr. 2019 Dec 1;110(6):1502-1509. doi: 10.1093/ajcn/nqz234.

    PubMed 31535138

  • Metherel AH, Irfan M, Klingel SL, Mutch DM, Bazinet RP. Compound-specific isotope analysis reveals no retroconversion of DHA to EPA but substantial conversion of EPA to DHA following supplementation: a randomized control trial. Am J Clin Nutr. 2019 Oct 1;110(4):823-831. doi: 10.1093/ajcn/nqz097.

    PubMed 31204771

Questions about this trial

What is this clinical trial studying?

A study testing High EPA Supplement and High DHA Supplement in people with Cardiovascular Disease, run by University of Guelph.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Omega-3 Index (time frame: CHANGE from Baseline at 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03378232, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2018.

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