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Skeletal Muscle Energy MetabolismNCT01732003

The Effect of Omega-3 Fatty Acid Supplementation on Skeletal Muscle Membrane Composition and Cellular Metabolism

A study testing Omega-3 Complete in people with Skeletal Muscle Energy Metabolism, run by University of Guelph at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 years, men onlyHealthy volunteers can take part
Conditions the study is for
Skeletal Muscle Energy Metabolism
What is being tested?
Omega-3 Complete
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteCanada
Study dates
Nov 2011to Feb 2013
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
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Christopher J Gerling, BScH contact

1-519-821-4120 ext. 53907

cgerling@uoguelph.ca

Canada1 site, 1 recruiting
  • University of Guelph

    Guelph, Ontario, N1G 2W1

    Recruiting

Other trials in Canada

About this study

Official title: The Effect of Omega-3 Fatty Acid Supplementation on Skeletal Muscle Plasma and Mitochondrial Membrane Composition and Cellular Metabolism

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.

Read more

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.

Being tested
Omega-3 Complete, Placebo Pill
Keywords
Omega-3, Skeletal Muscle, Eicosapentaenoic acid, Docosahexaenoic acid, Exercise, Membrane Composition, Lipid Metabolism
Medical subject headings
Motor Activity

What participants receive

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

  • Omega-3 CompleteDietary supplement

  • Placebo PillDietary supplement

Study groups in NCT01732003
Study groupRoleWhat they receive
Omega-3 CompleteExperimentalOral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks
Receives: Dietary Supplement: Omega-3 Complete
Placebo PillPlacebo comparatorOral ingestion of 5 capsules of a placebo oil pill (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks
Receives: Dietary Supplement: Placebo Pill

What is being measured

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

  1. Change in skeletal muscle whole muscle membrane fatty acid composition from baseline

    Percent change in the content of whole muscle membrane fatty acids

    Measured: Baseline and 12 weeks

  2. Change in skeletal muscle plasma membrane fatty acid composition from baseline

    Percent change in the content of plasma membrane fatty acids

    Measured: Baseline and 12 weeks

  3. Change in skeletal muscle mitochondrial membrane composition from baseline

    Percent change in the content of mitochondrial membrane fatty acids

    Measured: Baseline and 12 weeks

Secondary outcomes (4)
  1. Change in whole body resting fat oxidation from baseline

    Measured: Baseline and 12 weeks

  2. Change in whole body resting carbohydrate oxidation from baseline

    Measured: Baseline and 12 weeks

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

    Measured: Baseline and 12 weeks

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

    Measured: Baseline and 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 posted22 Nov 2012 (estimated)
  2. Study startNov 2011
  3. Primary completionFeb 2013 (estimated)
  4. Study completionFeb 2013 (estimated)

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
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01732003
Sponsor's protocol ID
11SE032
Status last verified
Nov 2012
First submitted
17 Nov 2012
Last updated
28 Nov 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 8598550
  • 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.

    PubMed 20691135
  • 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.

    PubMed 12450886
  • 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.

    PubMed 15481762
  • 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.

    PubMed 13129446
  • 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.

    PubMed 19034030

Questions about this trial

What is this clinical trial studying?

A study testing Omega-3 Complete in people with Skeletal Muscle Energy Metabolism, run by University of Guelph at 1 site in Canada.

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 11 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: status not confirmed, as of the sponsor's last update on 28 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

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

Contact Christopher J Gerling, BScH (1-519-821-4120 ext. 53907, cgerling@uoguelph.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in skeletal muscle whole muscle membrane fatty acid composition from baseline (time frame: Baseline and 12 weeks). The study lists 3 primary outcomes in all. 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 NCT01732003, which also lists 6 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 28 Nov 2012.

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