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Caffeine, Genetic Variation and Athletic Performance (GMC-AP)

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ClinicalTrials.gov Identifier: NCT02109783
Recruitment Status : Unknown
Verified November 2015 by Ahmed El-Sohemy, University of Toronto.
Recruitment status was:  Active, not recruiting
First Posted : April 10, 2014
Last Update Posted : December 2, 2015
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Nutrigenomix Inc.
Information provided by (Responsible Party):
Ahmed El-Sohemy, University of Toronto

Brief Summary:
Numerous studies have investigated the effect of caffeine on athletic performance, but the findings have not been consistent. This is due, in part, to the differences in response that has been observed both within and between studies. Previous research in our lab has shown that genetic variations affecting caffeine metabolism modify the association between caffeine and heart disease. We hypothesize that the inconsistencies among studies relating caffeine and athletic performance may be due to genetic differences in caffeine metabolism or response. Male athletes will take part in an intervention of caffeine versus placebo, using a randomized double-blinded placebo-controlled design, which will test various exercise protocols (power, strength, anaerobic capacity, endurance) that are associated with performance across multiple sports. We will conduct a genome-wide association study, which is an approach that involves scanning for markers across the genomes of our study participants together, not individuals, to find genetic variations associated with a particular trait such as VO2 max, lactate clearance efficiency, muscle fiber type and changes in exercise performance following caffeine. We will also examine known genetic variations that are associated with caffeine metabolism and response, to determine if these genes also affect response to exercise after ingesting caffeine. Subjects will be paid $50.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Caffeine 2mg Dietary Supplement: Caffeine 4 mg Dietary Supplement: Caffeine 0 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Genetic Modifiers of Caffeine Intake and Athletic Performance
Study Start Date : June 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Active Comparator: Caffeine 4 mg
To compare exercise performance of 2 or 4 mg of caffeine per kilogram of body weight to placebo within subjects. Subjects will perform 4 exercise tests.
Dietary Supplement: Caffeine 4 mg
To compare exercise performance of 2 or 4 mg of caffeine per kilogram of body weight to placebo within subjects. Subjects will perform 4 exercise tests.

Active Comparator: Caffeine 2 mg
To compare exercise performance of 2 or 4 mg of caffeine per kilogram of body weight to placebo within subjects. Subjects will perform 4 exercise tests.
Dietary Supplement: Caffeine 2mg
Caffeine 2 mg versus 4 mg/kg or placebo

Placebo Comparator: Caffeine 0 mg
To compare exercise performance of 2 or 4 mg of caffeine per kilogram of body weight to placebo within subjects. Subjects will perform 4 exercise tests.
Dietary Supplement: Caffeine 0
To compare exercise performance of 2 or 4 mg of caffeine per kilogram of body weight to placebo within subjects. Subjects will perform 4 exercise tests.




Primary Outcome Measures :
  1. Efficacy of caffeine to improve power, strength and speed [ Time Frame: 2 hours ]
    To determine if their is a positive effect (improvement) effect of 2 or 4 mg of caffeine per kilogram of body mass on four distinct components of fitness: power, strength, anaerobic and aerobic capacity. Therefore, to determine the efficacy of caffeine to shorten time to completion in time trial, and increase power/strength in wingate, vertical jump and handgrip tests.


Secondary Outcome Measures :
  1. Individual genotypes, caffeine ingestion and athletic performance [ Time Frame: 1 day ]
    Saliva samples will be taken for a genome-wide association scan (GWAS) and identification of genetic variations related to caffeine metabolism, in order to determine which genes are associated with improved performance during the caffeine treatment. Sport SNP's on genes such as ACE, ACTN3 and others will also be identified to determine associations to performance and/or descriptive statistics such as VO2 max.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy 18-35 yrs
  • athlete competing/training in given sport 3 or more years
  • currently competing at Varsity, Professional, National level or recreationally but also competing

Exclusion Criteria:

  • medical conditions affected by caffeine / avoidance of caffeine
  • injured / not training
  • unable to abstain from caffeine for 4 weeks during study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02109783


Locations
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Canada, Ontario
University ofToronto
Toronto, Ontario, Canada, M5S 3E2
Sponsors and Collaborators
University of Toronto
Canadian Institutes of Health Research (CIHR)
Nutrigenomix Inc.
Investigators
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Principal Investigator: Ahmed El-Sohemy, PhD University of Toronto
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ahmed El-Sohemy, Associate Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT02109783    
Other Study ID Numbers: 4168733312-CAF
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015
Keywords provided by Ahmed El-Sohemy, University of Toronto:
Athletes
Ergogenic aids
Caffeine
Nutrigenomics
Genotype
Additional relevant MeSH terms:
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Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents