Cardiometabolic Benefits of Omega-3 Polyunsaturated Fatty Acids

NCT ID: NCT03378232

Last Updated: 2018-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-05

Study Completion Date

2017-05-30

Brief Summary

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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

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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

Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Participant as well as student investigators were blinded to the treatment randomization.

Study Groups

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Placebo Olive Oil

Placebo supplement with olive oil

Group Type PLACEBO_COMPARATOR

Placebo Olive Oil

Intervention Type DIETARY_SUPPLEMENT

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

High EPA Supplement

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

Group Type EXPERIMENTAL

High EPA Supplement

Intervention Type DIETARY_SUPPLEMENT

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

High DHA Supplement

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

Group Type EXPERIMENTAL

High DHA Supplement

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Placebo Olive Oil

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

Intervention Type DIETARY_SUPPLEMENT

High EPA Supplement

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

Intervention Type DIETARY_SUPPLEMENT

High DHA Supplement

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ontario Ministry of Agriculture, Food and Rural Affairs

OTHER_GOV

Sponsor Role collaborator

University of Guelph

OTHER

Sponsor Role lead

Responsible Party

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David M Mutch

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David M Mutch, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Guelph

Phillip Millar, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Guelph

Lawrence Spriet, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Guelph

References

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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.

Reference Type BACKGROUND
PMID: 24936800 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27144909 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24610882 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20565855 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29080057 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38649096 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31535138 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31204771 (View on PubMed)

Other Identifiers

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The Goodness In Fish Oil

Identifier Type: -

Identifier Source: org_study_id

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