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The Influence of Caffeine Supplementation on Specific Performance and Training Activities

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ClinicalTrials.gov Identifier: NCT03822663
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : February 1, 2019
Sponsor:
Collaborator:
Poznan University of Physical Education
Information provided by (Responsible Party):
Krzysztof Durkalec-Michalski, PhD, Poznan University of Life Sciences

Tracking Information
First Submitted Date  ICMJE January 28, 2019
First Posted Date  ICMJE January 30, 2019
Last Update Posted Date February 1, 2019
Actual Study Start Date  ICMJE May 15, 2017
Estimated Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
Changes in discipline-specific exercise capacity after caffeine supplementation and placebo treatment [ Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation ]
Assessment of the discipline-specific exercise capacity tests carried out at baseline, and after CAF and PLA supplementation
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03822663 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
  • Changes in sports training / competition activities after discipline-specific exercise tests [ Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation ]
    Assessment of the sports training / competition activities after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
  • Changes in rate of perceived exertion after discipline-specific exercise tests [ Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation ]
    Assessment of the Borg Rating of Perceived Exertion (RPE) scale after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
  • Changes in heart rate during discipline-specific exercise tests [ Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation ]
    Assessment of the Heart Rate during and after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Influence of Caffeine Supplementation on Specific Performance and Training Activities
Official Title  ICMJE The Influence of Caffeine Supplementation on Discipline-Specific Performance and Training Activities in Combat Sports and Speed-Strength Disciplines
Brief Summary The purpose of this study is to verify the effect of acute caffeine (CAF) and placebo (PLA) supplementation on physical capacity and discipline-specific exercise performance in athletes, in a randomised, double-blind, placebo-controlled crossover trial.
Detailed Description

Caffeine (CAF) is often proposed as an ergogenic agent, especially during high-intensity efforts. CAF supplementation may reduce effort-induced multi-faceted symptoms of fatigue and can improve psychomotor functions (like agility or decision-making processes), which is required during the intermittent high-intensity efforts in combat sports and speed-strength disciplines. Moreover, it is suggested that CAF treatment is associated with increased glycolytic activity during simulated or real training/competition bouts, which results in performance and physical capacity improvement.

However, there are hardly any data on the individual CAF-induced and dose-dependent changes in physical capacity and discipline-specific performance in combat sports and speed-strength disciplines. Therefore, the study aims to examine the effect of acute, different-dose CAF ingestion on physical capacity and discipline-specific performance in combat sports and speed-strength athletes, in a randomized, double-blind, placebo-controlled crossover trial.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Supplementation
  • Sports
Intervention  ICMJE
  • Dietary Supplement: Caffeine supplementation
    The experimental procedure for each athlete includes an acute CAF supplementation in a different-dose crossover regimen in order to assess whether the dose affects the actual physical capacity and discipline-specific exercise performance (doses: 3.0-, 6.0- and 9.0 mg/kg of body mass, respectively). CAF (pure pharmaceutical caffeine) will be administered in the dissolved form. On testing days, the supplements will be taken 45 min before physical and exercise capacity test session. Between the CAF and PLA or a PLA and CAF treatments, a minimum 7-day washout period will be introduced.
  • Dietary Supplement: Placebo treatment
    The experimental procedure for each athlete will include PLA supplementation. Placebo will be administered in the dissolved form. On testing days, the PLA will be taken 45 min before physical and exercise capacity test session. Between the PLA and CAF or a CAF and PLA treatments, a minimum 7-day washout period will be introduced.
Study Arms  ICMJE
  • Experimental: Caffeine supplementation
    Group taking oral CAF (Caffeine) supplementation in a different-dose crossover regimen.
    Intervention: Dietary Supplement: Caffeine supplementation
  • Placebo Comparator: Placebo treatment
    Group taking oral supplementation with placebo.
    Intervention: Dietary Supplement: Placebo treatment
Publications * Durkalec-Michalski K, Nowaczyk PM, Główka N, Grygiel A. Dose-dependent effect of caffeine supplementation on judo-specific performance and training activity: a randomized placebo-controlled crossover trial. J Int Soc Sports Nutr. 2019 Sep 5;16(1):38. doi: 10.1186/s12970-019-0305-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 28, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2020
Estimated Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • written consent to participate,
  • a current medical clearance to practice sports,
  • training experience: at least 2 years,
  • minimum of 4 workout sessions (in the discipline covered by the study) a week.

Exclusion Criteria:

  • current injury,
  • any health-related contraindication,
  • declared general feeling of being unwell,
  • unwilling to follow the study protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Krzysztof Durkalec-Michalski, PhD +48 618 487 338 durkmich@up.poznan.pl
Contact: Paulina Nowaczyk, PhD +48 618 487 335 paulina.nowaczyk@up.poznan.pl
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03822663
Other Study ID Numbers  ICMJE ULS00007
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Shared data will be exclusively related to the level of recorded indicators, without personal data. The data obtained will be attached to scientific publications, depending on the requirements of the journal.
Responsible Party Krzysztof Durkalec-Michalski, PhD, Poznan University of Life Sciences
Study Sponsor  ICMJE Poznan University of Life Sciences
Collaborators  ICMJE Poznan University of Physical Education
Investigators  ICMJE
Principal Investigator: Krzysztof Durkalec-Michalski, PhD Poznan University of Life Sciences
PRS Account Poznan University of Life Sciences
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP