<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03822663</url>
  </required_header>
  <id_info>
    <org_study_id>ULS00007</org_study_id>
    <nct_id>NCT03822663</nct_id>
  </id_info>
  <brief_title>The Influence of Caffeine Supplementation on Specific Performance and Training Activities</brief_title>
  <official_title>The Influence of Caffeine Supplementation on Discipline-Specific Performance and Training Activities in Combat Sports and Speed-Strength Disciplines</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poznan University of Physical Education</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Poznan University of Life Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Poznan University of Physical Education</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to verify the effect of acute caffeine (CAF) and placebo (PLA)&#xD;
      supplementation on physical capacity and discipline-specific exercise performance in&#xD;
      athletes, in a randomised, double-blind, placebo-controlled crossover trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Caffeine (CAF) is often proposed as an ergogenic agent, especially during high-intensity&#xD;
      efforts. CAF supplementation may reduce effort-induced multi-faceted symptoms of fatigue and&#xD;
      can improve psychomotor functions (like agility or decision-making processes), which is&#xD;
      required during the intermittent high-intensity efforts in combat sports and speed-strength&#xD;
      disciplines. Moreover, it is suggested that CAF treatment is associated with increased&#xD;
      glycolytic activity during simulated or real training/competition bouts, which results in&#xD;
      performance and physical capacity improvement.&#xD;
&#xD;
      However, there are hardly any data on the individual CAF-induced and dose-dependent changes&#xD;
      in physical capacity and discipline-specific performance in combat sports and speed-strength&#xD;
      disciplines. Therefore, the study aims to examine the effect of acute, different-dose CAF&#xD;
      ingestion on physical capacity and discipline-specific performance in combat sports and&#xD;
      speed-strength athletes, in a randomized, double-blind, placebo-controlled crossover trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 15, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2023</completion_date>
  <primary_completion_date type="Actual">March 1, 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in discipline-specific exercise capacity after caffeine supplementation and placebo treatment</measure>
    <time_frame>Baseline and during 1 day of acute CAF and PLA supplementation</time_frame>
    <description>Assessment of the discipline-specific exercise capacity tests carried out at baseline, and after CAF and PLA supplementation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in sports training / competition activities after discipline-specific exercise tests</measure>
    <time_frame>Baseline and during 1 day of acute CAF and PLA supplementation</time_frame>
    <description>Assessment of the sports training / competition activities after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in rate of perceived exertion after discipline-specific exercise tests</measure>
    <time_frame>Baseline and during 1 day of acute CAF and PLA supplementation</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in heart rate during discipline-specific exercise tests</measure>
    <time_frame>Baseline and during 1 day of acute CAF and PLA supplementation</time_frame>
    <description>Assessment of the Heart Rate during and after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Supplementation</condition>
  <condition>Sports</condition>
  <arm_group>
    <arm_group_label>Caffeine supplementation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group taking oral CAF (Caffeine) supplementation in a different-dose crossover regimen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo treatment</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Group taking oral supplementation with placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Caffeine supplementation</intervention_name>
    <description>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.</description>
    <arm_group_label>Caffeine supplementation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo treatment</intervention_name>
    <description>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.</description>
    <arm_group_label>Placebo treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  written consent to participate,&#xD;
&#xD;
          -  a current medical clearance to practice sports,&#xD;
&#xD;
          -  training experience: at least 2 years,&#xD;
&#xD;
          -  minimum of 4 workout sessions (in the discipline covered by the study) a week.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current injury,&#xD;
&#xD;
          -  any health-related contraindication,&#xD;
&#xD;
          -  declared general feeling of being unwell,&#xD;
&#xD;
          -  unwilling to follow the study protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Krzysztof Durkalec-Michalski, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Sports Dietetics, Poznan University of Physical Education, Poznan, Poland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Sports Dietetics, Poznan University of Physical Education</name>
      <address>
        <city>Poznań</city>
        <state>Wielkopolska</state>
        <zip>61-871</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>April 6, 2023</last_update_submitted>
  <last_update_submitted_qc>April 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Poznan University of Physical Education</investigator_affiliation>
    <investigator_full_name>Krzysztof Durkalec-Michalski</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Sports nutrition</keyword>
  <keyword>Caffeine</keyword>
  <keyword>Physical capacity</keyword>
  <keyword>Exercise performance</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Caffeine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_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.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03822663
org study id: ULS00007
nct id: NCT03822663
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: 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
description: Assessment of the discipline-specific exercise capacity tests carried out at baseline, and after CAF and PLA supplementation
measure: Changes in sports training / competition activities after discipline-specific exercise tests
time frame: Baseline and during 1 day of acute CAF and PLA supplementation
description: Assessment of the sports training / competition activities after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
measure: Changes in rate of perceived exertion after discipline-specific exercise tests
time frame: Baseline and during 1 day of acute CAF and PLA supplementation
description: 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
measure: Changes in heart rate during discipline-specific exercise tests
time frame: Baseline and during 1 day of acute CAF and PLA supplementation
description: Assessment of the Heart Rate during and after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
arm group label: Caffeine supplementation
arm group type: Experimental
description: Group taking oral CAF (Caffeine) supplementation in a different-dose crossover regimen.
arm group label: Placebo treatment
arm group type: Placebo Comparator
description: Group taking oral supplementation with placebo.
intervention type: Dietary Supplement
intervention name: Caffeine supplementation
description: 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.
arm group label: Caffeine supplementation
intervention type: Dietary Supplement
intervention name: Placebo treatment
description: 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.
arm group label: Placebo treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Krzysztof Durkalec-Michalski, PhD
role: Principal Investigator
affiliation: Department of Sports Dietetics, Poznan University of Physical Education, Poznan, Poland
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Poznan University of Physical Education
investigator full name: Krzysztof Durkalec-Michalski
investigator title: Principal Investigator
mesh term: Caffeine
sharing ipd: Undecided
ipd 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.