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/NCT06016985</url>
    </required_header>
    <id_info>
      <org_study_id>112-1</org_study_id>
      <nct_id>NCT06016985</nct_id>
    </id_info>
    <brief_title>Effects of Caffeinated Gum on a Basketball-specific Tests in Trained University Male Basketball Players: a Crossover Trial</brief_title>
    <official_title>National Taiwan University of Sport</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chih-Hui Chiu</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Taiwan Sport University</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>
        This study investigated the effects of chewing 3 mg/kg of caffeinated gum on basketball free&#xD;
        throw accuracy and basketball -specific performance. Fourteen trained basketball players with&#xD;
        at least a top 8 national ranking were recruited to be participants in this study. After 2&#xD;
        simulation tests to familiarize the experimental procedure, we employed a double blind,&#xD;
        randomized crossover design to divide participants into caffeine trial (CAF) and placebo&#xD;
        trial (PL). The CAF trial chewed caffeine gum containing 3 mg/kg for 10 minutes, whereas the&#xD;
        PL trial chewed a placebo gum without caffeine. After 15 minutes rest, the stationary free&#xD;
        throw shooting test, countermovement jump, t-test, 20-meter segmented dash test, squat in the&#xD;
        flywheel device and running based anaerobic sprint test were conducted.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Actual">July 31, 2023</completion_date>
    <primary_completion_date type="Actual">July 31, 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>Treatment</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>stationary free throw</measure>
      <time_frame>15 min after intervention</time_frame>
      <description>The goal percentage of stationary free throw</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>20-meter segmented dash</measure>
      <time_frame>15 min after intervention</time_frame>
      <description>Test the sprinting speed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>fatigue index</measure>
      <time_frame>15 min after intervention</time_frame>
      <description>Completes six 35-meter sprints at maximum effort, with a 10-second break between each sprint. The time of completion of each sprint was recorded for subsequent analysis.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">14</enrollment>
    <condition>Caffeine</condition>
    <arm_group>
      <arm_group_label>caffeine gum</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Chewed caffeine gum containing 3 mg/kg for 10 minutes</description>
    </arm_group>
    <arm_group>
      <arm_group_label>placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Chewed placobo gum for 10 minutes</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>caffeine gum</intervention_name>
      <description>This study investigated the effects of chewing 3 mg/kg of caffeinated gum on basketball free throw accuracy and basketball -specific performance.</description>
      <arm_group_label>caffeine gum</arm_group_label>
      <arm_group_label>placebo</arm_group_label>
      <other_name>plocabo gum</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  6 years of professional basketball training and with at least a top 8 national ranking&#xD;
  &#xD;
            -  6 months of continuous training,&#xD;
  &#xD;
            -  3 months of recovery from sports injuries such as strains and sprains.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Non-specialized basketball players.&#xD;
  &#xD;
            -  has not trained regularly for the past 6 months.&#xD;
  &#xD;
            -  has recovered from from a sports injury for less than 3 months, or had epilepsy,&#xD;
               hypertension, hyperlipidemia, heart disease, arthritis, osteoporosis, brain injury, or&#xD;
               a history of caffeine allergy.&#xD;
  &#xD;
            -  Subjects with previous caffeine allergy response.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>National Taiwan University of Sport</name>
        <address>
          <city>Taichung</city>
          <zip>404</zip>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>National Taiwan Sport University</investigator_affiliation>
      <investigator_full_name>Chih-Hui Chiu</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Eccentric exercise</keyword>
    <keyword>basketball</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>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>October 1, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/85/NCT06016985/Prot_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06016985
  org study id: 112-1
  nct id: NCT06016985
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study investigated the effects of chewing 3 mg/kg of caffeinated gum on basketball free
        throw accuracy and basketball -specific performance. Fourteen trained basketball players with
        at least a top 8 national ranking were recruited to be participants in this study. After 2
        simulation tests to familiarize the experimental procedure, we employed a double blind,
        randomized crossover design to divide participants into caffeine trial (CAF) and placebo
        trial (PL). The CAF trial chewed caffeine gum containing 3 mg/kg for 10 minutes, whereas the
        PL trial chewed a placebo gum without caffeine. After 15 minutes rest, the stationary free
        throw shooting test, countermovement jump, t-test, 20-meter segmented dash test, squat in the
        flywheel device and running based anaerobic sprint test were conducted.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Single (Investigator)
  measure: stationary free throw
  time frame: 15 min after intervention
  description: The goal percentage of stationary free throw
  measure: 20-meter segmented dash
  time frame: 15 min after intervention
  description: Test the sprinting speed
  measure: fatigue index
  time frame: 15 min after intervention
  description: Completes six 35-meter sprints at maximum effort, with a 10-second break between each sprint. The time of completion of each sprint was recorded for subsequent analysis.
  arm group label: caffeine gum
  arm group type: Experimental
  description: Chewed caffeine gum containing 3 mg/kg for 10 minutes
  arm group label: placebo
  arm group type: Placebo Comparator
  description: Chewed placobo gum for 10 minutes
  intervention type: Dietary Supplement
  intervention name: caffeine gum
  description: This study investigated the effects of chewing 3 mg/kg of caffeinated gum on basketball free throw accuracy and basketball -specific performance.
  arm group label: caffeine gum
  arm group label: placebo
  other name: plocabo gum
  criteria: 
  gender: Male
  minimum age: 20 Years
  maximum age: 30 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Taiwan
  responsible party type: Sponsor-Investigator
  investigator affiliation: National Taiwan Sport University
  investigator full name: Chih-Hui Chiu
  investigator title: Professor
  mesh term: Caffeine
  sharing ipd: No
  provided document: 