NCT01732003

Brief Summary

The biological membranes that surround a cell and its organelles are vital to the overall function of the cell. Fatty acids are the main structural component of membranes, and the presence of specific fatty acids can alter a membrane's characteristics, which subsequently alters function. Two fatty acids that are of particular interest to researchers are eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). These omega-3 fatty acids have unique unsaturated structures, and their incorporation into biological membranes appear to elicit potent physiological effects. The body is unable to intrinsically synthesize these important fatty acids, so they must be obtained from the diet or through supplementation. Compared to research investigating other body tissues, the effect of EPA and DHA on skeletal muscle membranes and cellular function has received little attention. Of the studies done, EPA and DHA supplementation consistently results in increased EPA, DHA, and total omega-3 fatty acid content in the skeletal muscle membranes of rodents. One study has also demonstrated this effect in humans. These studies, however, have been limited to whole muscle measurements, yet cells contain numerous subcellular membranes with diverse functions. Two membranes of key importance to the metabolic function of a skeletal muscle cell are the membrane that surrounds the cell (plasma membrane), and the membrane that surrounds the mitochondria. The plasma and mitochondrial membranes are responsible for taking up nutrients and converting them into useable energy for the muscle. Recent findings suggest that physiological changes in these processes may occur following EPA and DHA supplementation. At rest and during exercise, there is potential for a shift in substrate selection that favors fat utilization following EPA and DHA supplementation. Several membrane proteins are responsible for transporting fat into the cell and mitochondria. The presence of EPA and DHA within membranes has the potential to affect the membrane integration and function of proteins. The investigators aim to determine whether fat utilization increases following EPA and DHA supplementation, and if there is a concurrent change in the concentrations of fat transport proteins within plasma and mitochondrial membranes. Supplementation with EPA and DHA may also affect oxygen consumption, an important process in energy production that is regulated by mitochondrial membrane proteins. Evidence from human and rodent studies shows a decrease in whole body oxygen consumption following supplementation. The investigators aim to examine these changes directly by measuring mitochondrial respiration following EPA and DHA supplementation. Therefore, the primary purpose of this study is to examine how plasma and mitochondrial membrane fatty acid composition change individually in response to EPA and DHA supplementation in humans. The secondary purpose of this study is to examine functional metabolic changes that occur in skeletal muscle in response to EPA and DHA supplementation, and to investigate correlational relationships between these changes and any compositional alterations in plasma and mitochondrial membranes. The investigators hypothesize that supplementation with EPA and DHA will alter fuel selection at rest and during exercise, and this will correspond to an increase in the concentration of membrane fatty acid transport proteins, and that these changes will correlate to an increase in the EPA, DHA, and total omega-3 content of plasma and mitochondrial membranes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 17, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 22, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

November 28, 2012

Status Verified

November 1, 2012

Enrollment Period

1.3 years

First QC Date

November 17, 2012

Last Update Submit

November 27, 2012

Conditions

Keywords

Omega-3Skeletal MuscleEicosapentaenoic acidDocosahexaenoic acidExerciseMembrane CompositionLipid Metabolism

Outcome Measures

Primary Outcomes (3)

  • Change in skeletal muscle whole muscle membrane fatty acid composition from baseline

    Percent change in the content of whole muscle membrane fatty acids

    Baseline and 12 weeks

  • Change in skeletal muscle plasma membrane fatty acid composition from baseline

    Percent change in the content of plasma membrane fatty acids

    Baseline and 12 weeks

  • Change in skeletal muscle mitochondrial membrane composition from baseline

    Percent change in the content of mitochondrial membrane fatty acids

    Baseline and 12 weeks

Secondary Outcomes (4)

  • Change in whole body resting fat oxidation from baseline

    Baseline and 12 weeks

  • Change in whole body resting carbohydrate oxidation from baseline

    Baseline and 12 weeks

  • Change in whole body sub-maximal exercise fat oxidation from baseline

    Baseline and 12 weeks

  • Change in whole body sub-maximal exercise carbohydrate oxidation from baseline

    Baseline and 12 weeks

Other Outcomes (24)

  • Change in resting heart rate from baseline

    Baseline and 12 weeks

  • Change in sub-maximal exercise heart rate from baseline

    Baseline and 12 weeks

  • Change in sub-maximal exercise blood free fatty acid concentration from baseline

    Baseline and 12 weeks

  • +21 more other outcomes

Study Arms (2)

Omega-3 Complete

EXPERIMENTAL

Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks

Dietary Supplement: Omega-3 Complete

Placebo Pill

PLACEBO COMPARATOR

Oral ingestion of 5 capsules of a placebo oil pill (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks

Dietary Supplement: Placebo Pill

Interventions

Omega-3 CompleteDIETARY_SUPPLEMENT
Omega-3 Complete
Placebo PillDIETARY_SUPPLEMENT
Placebo Pill

Eligibility Criteria

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

You may qualify if:

  • Recreationally active
  • Must currently practice a consistent diet, and exercise regimen, and maintain this throughout the duration of the study

You may not qualify if:

  • Current or previous supplementation with omega-3s
  • Average fish intake greater than two times per week
  • Sedentary
  • Highly active/trained
  • Diagnosed respiratory problem
  • Diagnosed heart problem/condition
  • Lightheadedness, shortness of breath, chest pain, numbness, fatigue, coughing, or wheezing during at rest of with low to moderate physical activity
  • Cardiovascular disease risk factors: Family history of heart attacks, hypertension, hypercholesterolemia, diabetes mellitus, smoking, obesity
  • Allergies to lidocaine, fish/fish oil, gelatine, glycerin, or mixed tocopherols
  • Currently taking any medications or supplements that may increase the chance of bleeding (e.g. Aspirin, Coumadin, Anti-inflammatories, Plavix, Vitamin C or E, high doses of garlic, ginkgo biloba, willow bark products)
  • Tendency toward easy bleeding or bruising

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Guelph

Guelph, Ontario, N1G 2W1, Canada

RECRUITING

Related Publications (6)

  • Ayre KJ, Hulbert AJ. Dietary fatty acid profile influences the composition of skeletal muscle phospholipids in rats. J Nutr. 1996 Mar;126(3):653-62. doi: 10.1093/jn/126.3.653.

    PMID: 8598550BACKGROUND
  • Peoples GE, McLennan PL. Dietary fish oil reduces skeletal muscle oxygen consumption, provides fatigue resistance and improves contractile recovery in the rat in vivo hindlimb. Br J Nutr. 2010 Dec;104(12):1771-9. doi: 10.1017/S0007114510002928. Epub 2010 Aug 9.

    PMID: 20691135BACKGROUND
  • Andersson A, Nalsen C, Tengblad S, Vessby B. Fatty acid composition of skeletal muscle reflects dietary fat composition in humans. Am J Clin Nutr. 2002 Dec;76(6):1222-9. doi: 10.1093/ajcn/76.6.1222.

    PMID: 12450886BACKGROUND
  • Couet C, Delarue J, Ritz P, Antoine JM, Lamisse F. Effect of dietary fish oil on body fat mass and basal fat oxidation in healthy adults. Int J Obes Relat Metab Disord. 1997 Aug;21(8):637-43. doi: 10.1038/sj.ijo.0800451.

    PMID: 15481762BACKGROUND
  • Delarue J, Labarthe F, Cohen R. Fish-oil supplementation reduces stimulation of plasma glucose fluxes during exercise in untrained males. Br J Nutr. 2003 Oct;90(4):777-86. doi: 10.1079/bjn2003964.

    PMID: 13129446BACKGROUND
  • Peoples GE, McLennan PL, Howe PR, Groeller H. Fish oil reduces heart rate and oxygen consumption during exercise. J Cardiovasc Pharmacol. 2008 Dec;52(6):540-7. doi: 10.1097/FJC.0b013e3181911913.

    PMID: 19034030BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Lawrence L Spriet, PhD

    University of Guelph

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher J Gerling, BScH

CONTACT

Jamie Whitfield, BA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair

Study Record Dates

First Submitted

November 17, 2012

First Posted

November 22, 2012

Study Start

November 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

November 28, 2012

Record last verified: 2012-11

Locations