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/NCT05975489</url>
    </required_header>
    <id_info>
      <org_study_id>UFV_genetic_caffeine</org_study_id>
      <nct_id>NCT05975489</nct_id>
    </id_info>
    <brief_title>Genetics in the Effect of Caffeine on Fat Oxidation</brief_title>
    <official_title>Influence of the Genetic Polymorphisms in the Effect of Caffeine on Fat Oxidation During Exercise</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universidad Francisco de Vitoria</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universidad Francisco de Vitoria</source>
    <oversight_info>
      <has_dmc>No</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>
        Genetic polymorphism on the effect of oral caffeine intake on fat oxidation during exercise&#xD;
        has been studied in active and healthy population performing an incremental test on a cycle&#xD;
        ergometer with 3-min stages at workloads from 30 to 70% of maximal oxygen uptake (VO2max).&#xD;
        Participants performed this test after the ingestion of a) placebo; b) 3 mg/kg of caffeine;&#xD;
        c) 6 mg/kg of caffeine. Fat oxidation rate during exercise was measured by indirect&#xD;
        calorimetry. The influence of the CYP1A2 c.-163A&gt;C, GSTP c.313A&gt;G and PGC1a polymorphisms was&#xD;
        evaluated to determine the effects on fat oxidation during exercise&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Caffeine is a natural stimulant with well-recognized sports performance benefits. Aside its&#xD;
        performance-enhancing effect, caffeine has the potential of increasing fat utilization during&#xD;
        aerobic exercise at submaximal intensities, lowering-down the contribution of carbohydrate as&#xD;
        a fuel. This property of caffeine may provoke a glycogen-sparing effect in the skeletal&#xD;
        muscle and liver for exercise situations where carbohydrate availability may be a challenge.&#xD;
        Additionally, the capacity of caffeine to enhance fat utilization during exercise could be of&#xD;
        interest for improving health outcomes as it may increase the rate of change in body&#xD;
        composition in exercise programs. Genetic factors like CYP1A2 c.-163A&gt;C, GSTP c.313A&gt;G and&#xD;
        PGC1a c.1444G&gt;A and C&gt;T polymorphisms could be associated with the capacity for fat oxidation&#xD;
        during exercise. To date, it is unknown if genetics increases fat oxidation and MFO in the&#xD;
        same proportion during morning and evening exercise trials in women. For this reason, the aim&#xD;
        of the present study was to evaluate the influence of the tCYP1A2, GSTP and PGC1a&#xD;
        polymorphisms on the effect of caffeine on fat oxidation and MFO in active and healthy&#xD;
        population. The authors hypothesised that genetics would increase fat oxidation and MFO&#xD;
        during exercise and this effect would be of similar magnitude at several caffeine doses.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 1, 2020</start_date>
    <completion_date type="Actual">April 1, 2022</completion_date>
    <primary_completion_date type="Actual">February 10, 2021</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>Parallel Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Genotype frequency of CYP1A2 polymorphism</measure>
      <time_frame>Baseline</time_frame>
      <description>Samples shall be obtained by swabbing and scraping of the buccal mucosa by the participant. The c.-163A&gt;C (rs762551) polymorphism will be used.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Genotype frequency of GSTP polymorphism</measure>
      <time_frame>Baseline</time_frame>
      <description>Samples shall be obtained by swabbing and scraping of the buccal mucosa by the participant. The c.1444G&gt;A (rs8192678) and C&gt;T (rs17650401) polymorphisms will be used.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Genotype frequency of PGC1a polymorphisms</measure>
      <time_frame>Baseline</time_frame>
      <description>Samples shall be obtained by swabbing and scraping of the buccal mucosa by the participant. The c.313A&gt;G (rs1695) polymorphism will be used.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>FATmax</measure>
      <time_frame>2-months</time_frame>
      <description>The intensity of exercise that elicits MFO</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MFO</measure>
      <time_frame>2-months</time_frame>
      <description>Maximal fat oxidation during exercise</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>RPE</measure>
      <time_frame>2-months</time_frame>
      <description>Rate of percevied exertion during exercise</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>FAT and CHO oxidation</measure>
      <time_frame>2-months</time_frame>
      <description>Fat and carbohydrates oxidation</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">32</enrollment>
    <condition>Genetic Predisposition</condition>
    <condition>Caffeine</condition>
    <condition>Fat Burn</condition>
    <arm_group>
      <arm_group_label>Caffeine 3mg/kg intake</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A dose of 3 mg/kg of caffeine (Bulk Powders, Essex, United Kingdom) was ingested before the beginning of each test.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Caffeine 6mg/kg intake</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A dose of 6 mg/kg of caffeine (Bulk Powders, Essex, United Kingdom) was ingested before the beginning of each test.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo intake</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>A dose of 3 mg/kg of placebo (Cellulose, Guinama, Valencia, Spain) was ingested before the beginning of each test.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Acute caffeine supplementation</intervention_name>
      <description>To evaluate the influence of the time of the day (i.e., morning vs evening) on the effect of caffeine on maximal fat oxidation in women</description>
      <arm_group_label>Caffeine 3mg/kg intake</arm_group_label>
      <arm_group_label>Caffeine 6mg/kg intake</arm_group_label>
      <arm_group_label>Placebo intake</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          To be non-smokers. To have low caffeine intake (i.e., &lt; 50 mg of caffeine per day in the&#xD;
          previous 2 months) To show no previous history of cardiopulmonary diseases or having&#xD;
          suffered musculoskeletal injuries in the previous 6 months.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          To have VO2max values below 40 ml/kg/min To be sedentary&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>David Varillas Delgado</last_name>
      <role>Principal Investigator</role>
      <affiliation>Universidad Francisco de Vitoria, crta Pozuelo-Majadahonda km 1.800 PC 28223, Madrid, Spain</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Universidad Francisco de Vitoria</name>
        <address>
          <city>Pozuelo De Alarcón</city>
          <state>Madrid</state>
          <zip>28223</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>July 2022</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Genetic Predisposition to Disease</mesh_term>
    </condition_browse>
    <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/NCT05975489
  org study id: UFV_genetic_caffeine
  nct id: NCT05975489
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Genetic polymorphism on the effect of oral caffeine intake on fat oxidation during exercise
        has been studied in active and healthy population performing an incremental test on a cycle
        ergometer with 3-min stages at workloads from 30 to 70% of maximal oxygen uptake (VO2max).
        Participants performed this test after the ingestion of a) placebo; b) 3 mg/kg of caffeine;
        c) 6 mg/kg of caffeine. Fat oxidation rate during exercise was measured by indirect
        calorimetry. The influence of the CYP1A2 c.-163A>C, GSTP c.313A>G and PGC1a polymorphisms was
        evaluated to determine the effects on fat oxidation during exercise
  Caffeine is a natural stimulant with well-recognized sports performance benefits. Aside its
        performance-enhancing effect, caffeine has the potential of increasing fat utilization during
        aerobic exercise at submaximal intensities, lowering-down the contribution of carbohydrate as
        a fuel. This property of caffeine may provoke a glycogen-sparing effect in the skeletal
        muscle and liver for exercise situations where carbohydrate availability may be a challenge.
        Additionally, the capacity of caffeine to enhance fat utilization during exercise could be of
        interest for improving health outcomes as it may increase the rate of change in body
        composition in exercise programs. Genetic factors like CYP1A2 c.-163A>C, GSTP c.313A>G and
        PGC1a c.1444G>A and C>T polymorphisms could be associated with the capacity for fat oxidation
        during exercise. To date, it is unknown if genetics increases fat oxidation and MFO in the
        same proportion during morning and evening exercise trials in women. For this reason, the aim
        of the present study was to evaluate the influence of the tCYP1A2, GSTP and PGC1a
        polymorphisms on the effect of caffeine on fat oxidation and MFO in active and healthy
        population. The authors hypothesised that genetics would increase fat oxidation and MFO
        during exercise and this effect would be of similar magnitude at several caffeine doses.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: Double (Participant, Outcomes Assessor)
  measure: Genotype frequency of CYP1A2 polymorphism
  time frame: Baseline
  description: Samples shall be obtained by swabbing and scraping of the buccal mucosa by the participant. The c.-163A>C (rs762551) polymorphism will be used.
  measure: Genotype frequency of GSTP polymorphism
  time frame: Baseline
  description: Samples shall be obtained by swabbing and scraping of the buccal mucosa by the participant. The c.1444G>A (rs8192678) and C>T (rs17650401) polymorphisms will be used.
  measure: Genotype frequency of PGC1a polymorphisms
  time frame: Baseline
  description: Samples shall be obtained by swabbing and scraping of the buccal mucosa by the participant. The c.313A>G (rs1695) polymorphism will be used.
  measure: FATmax
  time frame: 2-months
  description: The intensity of exercise that elicits MFO
  measure: MFO
  time frame: 2-months
  description: Maximal fat oxidation during exercise
  measure: RPE
  time frame: 2-months
  description: Rate of percevied exertion during exercise
  measure: FAT and CHO oxidation
  time frame: 2-months
  description: Fat and carbohydrates oxidation
  arm group label: Caffeine 3mg/kg intake
  arm group type: Experimental
  description: A dose of 3 mg/kg of caffeine (Bulk Powders, Essex, United Kingdom) was ingested before the beginning of each test.
  arm group label: Caffeine 6mg/kg intake
  arm group type: Experimental
  description: A dose of 6 mg/kg of caffeine (Bulk Powders, Essex, United Kingdom) was ingested before the beginning of each test.
  arm group label: Placebo intake
  arm group type: Placebo Comparator
  description: A dose of 3 mg/kg of placebo (Cellulose, Guinama, Valencia, Spain) was ingested before the beginning of each test.
  intervention type: Dietary Supplement
  intervention name: Acute caffeine supplementation
  description: To evaluate the influence of the time of the day (i.e., morning vs evening) on the effect of caffeine on maximal fat oxidation in women
  arm group label: Caffeine 3mg/kg intake
  arm group label: Caffeine 6mg/kg intake
  arm group label: Placebo intake
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: David Varillas Delgado
  role: Principal Investigator
  affiliation: Universidad Francisco de Vitoria, crta Pozuelo-Majadahonda km 1.800 PC 28223, Madrid, Spain
  facility: 
  country: Spain
  responsible party type: Sponsor
  mesh term: Genetic Predisposition to Disease
  mesh term: Caffeine
  sharing ipd: No