NCT02014233

Brief Summary

Nerves are the rate limiting factor that control muscle function. However, it is unknown if a nutritional supplement can change the nerve-muscle interaction, and therefore alter human performance. This study will be the first to examine the effects of omega-3 supplementation on neuromuscular function in trained individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

June 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 18, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

May 20, 2016

Status Verified

May 1, 2016

Enrollment Period

9 months

First QC Date

October 25, 2013

Last Update Submit

May 19, 2016

Conditions

Muscle FatigueMuscle Strength

Keywords

Randomized clinical trialHumansOmega-3 fatty acidsEssential fatty acidNeuromuscular functionWingateMaximum voluntary contractionElectromyographySeal oilCycling time trialPlacebo controlled

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in maximum voluntary contraction force

    Participants will be seated with their right knee fixed at 90°. The right ankle will be restrained by a padded cuff attached in series to a load cell. Participants will be instructed to contract their quadriceps maximally by trying to extending their leg. The load cell will measure the maximum force produced.

    21 days

Secondary Outcomes (11)

  • Change from baseline in vertical jump height

    21 days

  • Change from baseline in number of push-ups

    21 days

  • Change from baseline in number of 10RM squats

    21 days

  • Change from baseline in Wingate test peak power

    21 days

  • Change from baseline in 250 kJ cycling time trial time to completion

    Baseline and 21 days

  • +6 more secondary outcomes

Study Arms (2)

Omega-3

EXPERIMENTAL

Participants will consume 5 mL of omega-3 (2333 mg essential fatty acids) with 1000 IU vitamin D3 for 21 days.

Dietary Supplement: Omega-3

Olive oil

PLACEBO COMPARATOR

Participants will consume 5 mL of olive oil with 1000 IU vitamin D3 for 21 days.

Dietary Supplement: Olive oil

Interventions

Omega-3DIETARY_SUPPLEMENT
Also known as: Auum Omega Sublingual D, NPN 80014581
Omega-3
Olive oilDIETARY_SUPPLEMENT
Olive oil

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • At least 2 years training experience that includes resistance training, specifically back squat
  • Successfully completing a Par-Q questionnaire

You may not qualify if:

  • Individuals that have or are currently taking an omega-3 and/or omega-6 supplement within 4 weeks of the study
  • Individuals that have taken mammalian based omega-3 or 6 supplements in the past 6 months
  • Individuals consuming fish more than twice per week within 4 weeks of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto

Toronto, Ontario, M5S 3E2, Canada

Location

Related Publications (5)

  • Millet GY, Tomazin K, Verges S, Vincent C, Bonnefoy R, Boisson RC, Gergele L, Feasson L, Martin V. Neuromuscular consequences of an extreme mountain ultra-marathon. PLoS One. 2011 Feb 22;6(2):e17059. doi: 10.1371/journal.pone.0017059.

    PMID: 21364944BACKGROUND

  • Presland JD, Dowson MN, Cairns SP. Changes of motor drive, cortical arousal and perceived exertion following prolonged cycling to exhaustion. Eur J Appl Physiol. 2005 Sep;95(1):42-51. doi: 10.1007/s00421-005-1395-3. Epub 2005 Jun 23.

    PMID: 15976997BACKGROUND

  • Rodacki CL, Rodacki AL, Pereira G, Naliwaiko K, Coelho I, Pequito D, Fernandes LC. Fish-oil supplementation enhances the effects of strength training in elderly women. Am J Clin Nutr. 2012 Feb;95(2):428-36. doi: 10.3945/ajcn.111.021915. Epub 2012 Jan 4.

    PMID: 22218156BACKGROUND

  • MERTON PA. Voluntary strength and fatigue. J Physiol. 1954 Mar 29;123(3):553-64. doi: 10.1113/jphysiol.1954.sp005070. No abstract available.

    PMID: 13152698BACKGROUND

  • Behm DG, St-Pierre DM, Perez D. Muscle inactivation: assessment of interpolated twitch technique. J Appl Physiol (1985). 1996 Nov;81(5):2267-73. doi: 10.1152/jappl.1996.81.5.2267.

    PMID: 8941554BACKGROUND

MeSH Terms

Interventions

Docosahexaenoic AcidsOlive Oil

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsFats, UnsaturatedPlant OilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Thomas MS Wolever, MD, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 25, 2013

First Posted

December 18, 2013

Study Start

June 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

May 20, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)