xml: <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/NCT05995314</url>
    </required_header>
    <id_info>
      <org_study_id>CAF_MR_2023</org_study_id>
      <nct_id>NCT05995314</nct_id>
    </id_info>
    <brief_title>Effects Of Caffeine On Cognitive Performance</brief_title>
    <official_title>Effects Of Different Doses Of Caffeine On Cognitive Performance In Healthy Physically Active Individuals</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Castilla-La Mancha</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Castilla-La Mancha</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Caffeine is a potent central nervous system stimulant that increases the activity in the&#xD;
        prefrontal cortex and can improve cognitive skills. An improvement in these cognitive skills&#xD;
        can lead to further benefits in athletic performance. Therefore, it is necessary to clarify&#xD;
        the dose-response of caffeine on cognitive performance.The aim of this research will be to&#xD;
        determine the effects of different doses of caffeine on sport-related cognitive aspects.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators will require healthy, physically active young adults to complete three&#xD;
        trials under the conditions: a) placebo, b) 3 mg/kg, or c) 6 mg/kg body mass of caffeine. In&#xD;
        each trial, different cognitive abilities will be assessed using the following test&#xD;
        batteries: reaction time (DynavisionTM D2), anticipation (Bassin Anticipation Timer),&#xD;
        sustained attention (Go/No-Go and Eriksen Flanker Test) and memory tests. In addition, side&#xD;
        effects and the perceived sensation index will be recorded 24 h after each test.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 7, 2023</start_date>
    <completion_date type="Actual">September 4, 2023</completion_date>
    <primary_completion_date type="Actual">September 4, 2023</primary_completion_date>
    <phase>N/A</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>Other</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
      <masking_description>To achieve the blinded placebo situation, a researcher not associated with the study will be performed the blinding and prepared identical capsules containing placebo or the corresponding dose of caffeine. This researcher will be assigned an alphanumeric code to each trial to blind participants and investigators</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Reaction Time</measure>
      <time_frame>10 minutes</time_frame>
      <description>Reaction time (in seconds) shall be assessed with the Dynavision™ D2 Visomotor Device using the &quot;Reaction Time Test&quot;. In this test the fastest visual, motor and physical reaction time will be measured.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Anticipation</measure>
      <time_frame>5 minutes</time_frame>
      <description>Visual acuity related to hand-eye coordination and anticipation will be assessed using the Bassin Anticipation Timer instrument. The best anticipation time (in seconds) of each condition (5, 10 and 15 mph) will be taken.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sustained attention</measure>
      <time_frame>10 minutes</time_frame>
      <description>The ability of maintaining the attention and inhibiting an appropriate response will be measured by &quot;Go/No-Go Test&quot; [fastest, slowest, and average response time (in seconds), and successful attempts (percentage; %)] and &quot;Eriksen Flanker Test&quot; [congruent and incongruent reaction time (in seconds)].</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Memory</measure>
      <time_frame>20 minutes</time_frame>
      <description>To study the modulation of memory storage processes, three 20-item word lists were created. Each word in the list will be presented for 5 s. This will be followed by a 100 s memory consolidation interval, after which there will be a 120 s period in which as many words as the participants can remember will be written down (First time). After 15 min, participants will perform a recall task (Second time) in which they will have to rewrite all the words they remember at that time.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>Caffeine</condition>
    <arm_group>
      <arm_group_label>PLACEBO</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>placebo (0 mg/kg of body mass of caffeine). The capsule will be filled with 3 mg/kg of body mass of cellulose.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>3mg/kg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>3 mg/kg of body mass of caffeine (99% caffeine, Bulkpowders, United Kingdom).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>6mg/kg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>6 mg/kg of body mass of caffeine (99% caffeine, Bulkpowders, United Kingdom).</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>PLACEBO</intervention_name>
      <description>3 mg/kg of cellulose (0 mg/kg of caffeine)</description>
      <arm_group_label>PLACEBO</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>3 mg/kg of caffeine</intervention_name>
      <description>Ingestion of 3 mg/kg of body mass of caffeine</description>
      <arm_group_label>3mg/kg</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>6 mg/kg of caffeine</intervention_name>
      <description>Ingestion of 6 mg/kg of body mass of caffeine</description>
      <arm_group_label>6mg/kg</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Physically active individuals ( &gt;150 min/week moderate physical activity or &gt;75&#xD;
               min/week vigorous physical activity)&#xD;
  &#xD;
            -  Individuals without serious and undiagnosed health problems.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals with color blindness.&#xD;
  &#xD;
            -  Regular caffeine consumers (&gt;3 cups of coffee/day).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Javier Abián-Vicén, PhD</last_name>
      <role>Study Director</role>
      <affiliation>University of Castilla-La Mancha</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Performance and Sport Rehabilitation Laboratory</name>
        <address>
          <city>Toledo</city>
          <zip>45071</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>ergogenic aid</keyword>
    <keyword>sport performance</keyword>
    <keyword>reaction time</keyword>
    <keyword>anticipation</keyword>
    <keyword>attention</keyword>
    <keyword>memory</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>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05995314
  org study id: CAF_MR_2023
  nct id: NCT05995314
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Caffeine is a potent central nervous system stimulant that increases the activity in the
        prefrontal cortex and can improve cognitive skills. An improvement in these cognitive skills
        can lead to further benefits in athletic performance. Therefore, it is necessary to clarify
        the dose-response of caffeine on cognitive performance.The aim of this research will be to
        determine the effects of different doses of caffeine on sport-related cognitive aspects.
  The investigators will require healthy, physically active young adults to complete three
        trials under the conditions: a) placebo, b) 3 mg/kg, or c) 6 mg/kg body mass of caffeine. In
        each trial, different cognitive abilities will be assessed using the following test
        batteries: reaction time (DynavisionTM D2), anticipation (Bassin Anticipation Timer),
        sustained attention (Go/No-Go and Eriksen Flanker Test) and memory tests. In addition, side
        effects and the perceived sensation index will be recorded 24 h after each test.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Other
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  masking description: To achieve the blinded placebo situation, a researcher not associated with the study will be performed the blinding and prepared identical capsules containing placebo or the corresponding dose of caffeine. This researcher will be assigned an alphanumeric code to each trial to blind participants and investigators
  measure: Reaction Time
  time frame: 10 minutes
  description: Reaction time (in seconds) shall be assessed with the Dynavision™ D2 Visomotor Device using the "Reaction Time Test". In this test the fastest visual, motor and physical reaction time will be measured.
  measure: Anticipation
  time frame: 5 minutes
  description: Visual acuity related to hand-eye coordination and anticipation will be assessed using the Bassin Anticipation Timer instrument. The best anticipation time (in seconds) of each condition (5, 10 and 15 mph) will be taken.
  measure: Sustained attention
  time frame: 10 minutes
  description: The ability of maintaining the attention and inhibiting an appropriate response will be measured by "Go/No-Go Test" [fastest, slowest, and average response time (in seconds), and successful attempts (percentage; %)] and "Eriksen Flanker Test" [congruent and incongruent reaction time (in seconds)].
  measure: Memory
  time frame: 20 minutes
  description: To study the modulation of memory storage processes, three 20-item word lists were created. Each word in the list will be presented for 5 s. This will be followed by a 100 s memory consolidation interval, after which there will be a 120 s period in which as many words as the participants can remember will be written down (First time). After 15 min, participants will perform a recall task (Second time) in which they will have to rewrite all the words they remember at that time.
  arm group label: PLACEBO
  arm group type: Placebo Comparator
  description: placebo (0 mg/kg of body mass of caffeine). The capsule will be filled with 3 mg/kg of body mass of cellulose.
  arm group label: 3mg/kg
  arm group type: Experimental
  description: 3 mg/kg of body mass of caffeine (99% caffeine, Bulkpowders, United Kingdom).
  arm group label: 6mg/kg
  arm group type: Experimental
  description: 6 mg/kg of body mass of caffeine (99% caffeine, Bulkpowders, United Kingdom).
  intervention type: Dietary Supplement
  intervention name: PLACEBO
  description: 3 mg/kg of cellulose (0 mg/kg of caffeine)
  arm group label: PLACEBO
  intervention type: Dietary Supplement
  intervention name: 3 mg/kg of caffeine
  description: Ingestion of 3 mg/kg of body mass of caffeine
  arm group label: 3mg/kg
  intervention type: Dietary Supplement
  intervention name: 6 mg/kg of caffeine
  description: Ingestion of 6 mg/kg of body mass of caffeine
  arm group label: 6mg/kg
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 30 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Javier Abián-Vicén, PhD
  role: Study Director
  affiliation: University of Castilla-La Mancha
  facility: 
  country: Spain
  responsible party type: Sponsor
  mesh term: Caffeine
  sharing ipd: No