NCT03378232

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2017

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
Last Updated

February 20, 2018

Status Verified

February 1, 2018

Enrollment Period

5 months

First QC Date

December 12, 2017

Last Update Submit

February 16, 2018

Conditions

Cardiovascular Disease

Keywords

DHAEPAfatty acidsblood pressureresting metabolic rateblood lipidsmuscle sympathetic nerve activity (MSNA)

Outcome Measures

Primary Outcomes (1)

  • Omega-3 Index

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

    CHANGE from Baseline at 12 weeks

Secondary Outcomes (5)

  • Triglycerides

    CHANGE from Baseline at 12 weeks

  • High-sensitivity C-Reactive Protein (hs-CRP)

    CHANGE from Baseline at 12 weeks

  • Energy Expenditure

    CHANGE from Baseline at 12 weeks

  • Blood Pressure

    CHANGE from Baseline at 12 weeks

  • Muscle sympathetic nerve activity (MSNA)

    Change from Baseline at 12 weeks

Study Arms (3)

Placebo Olive Oil

PLACEBO COMPARATOR

Placebo supplement with olive oil

Dietary Supplement: Placebo Olive Oil

High EPA Supplement

EXPERIMENTAL

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

Dietary Supplement: High EPA Supplement

High DHA Supplement

EXPERIMENTAL

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

Dietary Supplement: High DHA Supplement

Interventions

Placebo Olive OilDIETARY_SUPPLEMENT

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

Placebo Olive Oil
High EPA SupplementDIETARY_SUPPLEMENT

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

High EPA Supplement
High DHA SupplementDIETARY_SUPPLEMENT

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

High DHA Supplement

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 18-30 years
  • Healthy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 24936800BACKGROUND

  • 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.

    PMID: 27144909BACKGROUND

  • 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.

    PMID: 24610882BACKGROUND

  • 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.

    PMID: 20565855BACKGROUND

  • 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.

    PMID: 29080057BACKGROUND

  • 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.

    PMID: 38649096DERIVED

  • 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.

    PMID: 31535138DERIVED

  • 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.

    PMID: 31204771DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • David M Mutch, PhD

    University of Guelph

    PRINCIPAL INVESTIGATOR

  • Phillip Millar, PhD

    University of Guelph

    PRINCIPAL INVESTIGATOR

  • Lawrence Spriet, PhD

    University of Guelph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participant as well as student investigators were blinded to the treatment randomization.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 12, 2017

First Posted

December 19, 2017

Study Start

January 5, 2017

Primary Completion

May 26, 2017

Study Completion

May 30, 2017

Last Updated

February 20, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share