<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/NCT03749785</url>
  </required_header>
  <id_info>
    <org_study_id>18/SW/0177</org_study_id>
    <nct_id>NCT03749785</nct_id>
  </id_info>
  <brief_title>Carbohydrate Feeding Frequency, Muscle Glycogen and Exercise Capacity in Runners</brief_title>
  <official_title>The Effect of Carbohydrate Feeding Frequency on Muscle Glycogen and Exercise Capacity in Runners</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bath</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Bath</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>
      The aim of this study is to investigate the effects of regular sucrose feeds compared to a&#xD;
      single large bolus given late in exercise, on muscle glycogen utilisation, exercise capacity&#xD;
      and other markers of metabolism during running&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 14, 2018</start_date>
  <completion_date type="Actual">April 16, 2019</completion_date>
  <primary_completion_date type="Actual">March 20, 2019</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle glycogen concentrations</measure>
    <time_frame>Estimated to be between 90 and 145 minutes</time_frame>
    <description>Muscle glycogen concentration at rest, after 75 minutes of treadmill running and at volitional exhaustion. Measured using the bergstrom needle technique for obtaining muscle biopsy samples</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exercise capacity</measure>
    <time_frame>Estimated to be between 90 and 145 minutes</time_frame>
    <description>Time to exhaustion at the pre-determined speed to elicit exhaustion after ~90 minutes when ingesting water only</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ratings of perceived exertion</measure>
    <time_frame>Estimated to be between 90 and 145 minutes</time_frame>
    <description>Subjective ratings of perceived exertion, during treadmill running. Measured using a borg scale of 6 to 20, where 6 = no exertion at all, and 20 = maximal exertion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratings of stomach discomfort</measure>
    <time_frame>Estimated to be between 90 and 145 minutes</time_frame>
    <description>Subjective ratings of stomach discomfort during treadmill running. Measured using a modified borg scale of 6 to 20, where 6 = no discomfort and 20 = maximal discomfort</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Carbohydrate oxidation</measure>
    <time_frame>Estimated to be between 90 and 145 minutes</time_frame>
    <description>Total carbohydrate oxidation during treadmill running. Measured using indirect calorimetry and reported in grams.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat oxidation</measure>
    <time_frame>Estimated to be between 90 and 145 minutes</time_frame>
    <description>Total fat oxidation during treadmill running. Measured using indirect calorimetry and reported in grams.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma glucose concentrations</measure>
    <time_frame>Estimated to be between 90 and 145 minutes</time_frame>
    <description>Plasma lactate concentrations during of treadmill running. Measured using colourimetric assay and reported in mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma lactate concentrations</measure>
    <time_frame>Estimated to be between 90 and 145 minutes</time_frame>
    <description>Plasma lactate concentrations during treadmill running. Measured using colourimetric assay and reported in mmol/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>Estimated to be between 90 and 145 minutes</time_frame>
    <description>Heart rate during treadmill running measured by telemetry and reported in beats per minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of oxygen consumption</measure>
    <time_frame>Estimated to be between 90 and 145 minutes</time_frame>
    <description>Rate of oxygen consumption during treadmill running. Measured using indirect calorimetry and reported in litres per minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of carbon dioxide production</measure>
    <time_frame>Estimated to be between 90 and 145 minutes</time_frame>
    <description>Rate of carbon dioxide production during treadmill running. Measured using indirect calorimetry and reported in litres per minute.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Exercise</condition>
  <arm_group>
    <arm_group_label>Regular carbohydrate feeding</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ingestion of 75 g sucrose, given in regular doses for the first 75 minutes of exercise during a time to exhaustion run</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single carbohydrate bolus</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ingestion of 75 g sucrose, given in a single bolus after 75 minutes of exercise, during a time to exhaustion run</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Regular carbohydrate feeding</intervention_name>
    <description>60 ml of water with 5 g sucrose given every 5 minutes 14 times up until 70 minutes followed by 5 g sucrose after 75 minutes in a 250 ml solution</description>
    <arm_group_label>Regular carbohydrate feeding</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Single carbohydrate bolus</intervention_name>
    <description>60 ml of water given every 5 minutes 14 times up until 70 minutes followed by 75 g sucrose after 75 minutes in a 250 ml solution</description>
    <arm_group_label>Single carbohydrate bolus</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Self-identify as a trained runner&#xD;
&#xD;
          -  Regularly participate in running activity (&gt;2 times a week)&#xD;
&#xD;
          -  Participated in running based training for a minimum of 2 years&#xD;
&#xD;
          -  Be willing to undertake exercise sessions until volitional exhaustion&#xD;
&#xD;
          -  Be willing to have the necessary samples taken during the testing protocols&#xD;
&#xD;
          -  Not a habitual smoker&#xD;
&#xD;
          -  Have the capacity and willingness to provide informed consent (oral and written)&#xD;
&#xD;
          -  Successful completion of the physical activity readiness questionnaire (PAR-Q)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  &lt;18 or &gt;50 years old&#xD;
&#xD;
          -  Not regularly participating in running activity (&lt;3 times a week)&#xD;
&#xD;
          -  Experience contraindications to the administration of the proposed anaesthetic&#xD;
             (Lidocaine Hydrochloride)&#xD;
&#xD;
          -  Habitual/previously habitual smoker&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department for Health, University of Bath</name>
      <address>
        <city>Bath</city>
        <zip>BA2 7AY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>October 31, 2019</last_update_submitted>
  <last_update_submitted_qc>October 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Bath</investigator_affiliation>
    <investigator_full_name>James Betts</investigator_full_name>
    <investigator_title>Professor, Department for Health</investigator_title>
  </responsible_party>
  <!-- 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/NCT03749785
org study id: 18/SW/0177
nct id: NCT03749785
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate the effects of regular sucrose feeds compared to a
      single large bolus given late in exercise, on muscle glycogen utilisation, exercise capacity
      and other markers of metabolism during running
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Muscle glycogen concentrations
time frame: Estimated to be between 90 and 145 minutes
description: Muscle glycogen concentration at rest, after 75 minutes of treadmill running and at volitional exhaustion. Measured using the bergstrom needle technique for obtaining muscle biopsy samples
measure: Exercise capacity
time frame: Estimated to be between 90 and 145 minutes
description: Time to exhaustion at the pre-determined speed to elicit exhaustion after ~90 minutes when ingesting water only
measure: Ratings of perceived exertion
time frame: Estimated to be between 90 and 145 minutes
description: Subjective ratings of perceived exertion, during treadmill running. Measured using a borg scale of 6 to 20, where 6 = no exertion at all, and 20 = maximal exertion.
measure: Ratings of stomach discomfort
time frame: Estimated to be between 90 and 145 minutes
description: Subjective ratings of stomach discomfort during treadmill running. Measured using a modified borg scale of 6 to 20, where 6 = no discomfort and 20 = maximal discomfort
measure: Carbohydrate oxidation
time frame: Estimated to be between 90 and 145 minutes
description: Total carbohydrate oxidation during treadmill running. Measured using indirect calorimetry and reported in grams.
measure: Fat oxidation
time frame: Estimated to be between 90 and 145 minutes
description: Total fat oxidation during treadmill running. Measured using indirect calorimetry and reported in grams.
measure: Plasma glucose concentrations
time frame: Estimated to be between 90 and 145 minutes
description: Plasma lactate concentrations during of treadmill running. Measured using colourimetric assay and reported in mmol/L
measure: Plasma lactate concentrations
time frame: Estimated to be between 90 and 145 minutes
description: Plasma lactate concentrations during treadmill running. Measured using colourimetric assay and reported in mmol/L.
measure: Heart rate
time frame: Estimated to be between 90 and 145 minutes
description: Heart rate during treadmill running measured by telemetry and reported in beats per minute
measure: Rate of oxygen consumption
time frame: Estimated to be between 90 and 145 minutes
description: Rate of oxygen consumption during treadmill running. Measured using indirect calorimetry and reported in litres per minute
measure: Rate of carbon dioxide production
time frame: Estimated to be between 90 and 145 minutes
description: Rate of carbon dioxide production during treadmill running. Measured using indirect calorimetry and reported in litres per minute.
arm group label: Regular carbohydrate feeding
arm group type: Active Comparator
description: Ingestion of 75 g sucrose, given in regular doses for the first 75 minutes of exercise during a time to exhaustion run
arm group label: Single carbohydrate bolus
arm group type: Active Comparator
description: Ingestion of 75 g sucrose, given in a single bolus after 75 minutes of exercise, during a time to exhaustion run
intervention type: Other
intervention name: Regular carbohydrate feeding
description: 60 ml of water with 5 g sucrose given every 5 minutes 14 times up until 70 minutes followed by 5 g sucrose after 75 minutes in a 250 ml solution
arm group label: Regular carbohydrate feeding
intervention type: Other
intervention name: Single carbohydrate bolus
description: 60 ml of water given every 5 minutes 14 times up until 70 minutes followed by 75 g sucrose after 75 minutes in a 250 ml solution
arm group label: Single carbohydrate bolus
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Bath
investigator full name: James Betts
investigator title: Professor, Department for Health