<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/NCT01709617</url>
  </required_header>
  <id_info>
    <org_study_id>12-3-048</org_study_id>
    <nct_id>NCT01709617</nct_id>
  </id_info>
  <brief_title>Carbohydrate Use During and Following Exercise</brief_title>
  <acronym>CHO-use</acronym>
  <official_title>Sucrose as a Preferred Carbohydrate in Sports Nutrition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Carbohydrates are an integral component of sports nutrition. Providing carbohydrate (CHO)&#xD;
      during exercise delays the onset of fatigue and improves exercise performance by maintaining&#xD;
      high rates of CHO oxidation. Traditionally, glucose, or glucose polymers have been the&#xD;
      preferential CHO source found in sports drinks. However, during the intestinal absorption of&#xD;
      large amounts of glucose (&gt;1.2 g/min), sodium-dependent glucose transporters (SGLT1) may&#xD;
      become fully saturated, potentially limiting the rate of exogenous CHO oxidation. In an&#xD;
      effort to evade this limitation, research has suggested using multiple transportable&#xD;
      carbohydrates in the composition of sports drinks. Multiple transportable carbohydrates are&#xD;
      combinations of simple sugars that use different intestinal transporters during the&#xD;
      absorption process. Ingesting multiple transportable carbohydrates may enhance the capacity&#xD;
      for total intestinal CHO absorption, leading to an increase in the rate of exogenous CHO&#xD;
      oxidation. Our purpose will be to examine the disaccharide sucrose in it's ability to provide&#xD;
      exogenous fuel during and following prolonged exercise.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">January 2014</completion_date>
  <primary_completion_date type="Anticipated">September 2013</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>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Exogenous carbohydrate oxidation rate (Part A)</measure>
    <time_frame>0 min during trials 1-3</time_frame>
    <description>Carbohydrate oxidation as measured by breath samples</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Endogenous carbohydrate oxidation (Part A)</measure>
    <time_frame>0 min during trials 1-3</time_frame>
    <description>endogenous carbohydrate oxidation as measured through breath samples during trials 1-3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glycogen utilization (Part B)</measure>
    <time_frame>immediately post exercise (~90min), during trials 4-6</time_frame>
    <description>Glycogen utilization measured through a muscle biopsy sample at post (~90 min), 3 and 6 h post exercise.&#xD;
Part B; trials 4-6.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exogenous carbohydrate oxidation rate (Part A)</measure>
    <time_frame>30 min during trials 1-3</time_frame>
    <description>Carbohydrate oxidation as measured by breath samples</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exogenous carbohydrate oxidation rate (Part A)</measure>
    <time_frame>60 min during trials 1-3</time_frame>
    <description>Carbohydrate oxidation as measured by breath samples</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exogenous carbohydrate oxidation rate (Part A)</measure>
    <time_frame>90 min during trials 1-3</time_frame>
    <description>Carbohydrate oxidation as measured by breath samples</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exogenous carbohydrate oxidation rate (Part A)</measure>
    <time_frame>120 min during trials 1-3</time_frame>
    <description>Carbohydrate oxidation as measured by breath samples</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exogenous carbohydrate oxidation rate (Part A)</measure>
    <time_frame>150 min during trials 1-3</time_frame>
    <description>Carbohydrate oxidation as measured by breath samples</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exogenous carbohydrate oxidation rate (Part A)</measure>
    <time_frame>180 min during trials 1-3</time_frame>
    <description>Carbohydrate oxidation as measured by breath samples</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Endogenous carbohydrate oxidation (Part A)</measure>
    <time_frame>30 min during trials 1-3</time_frame>
    <description>endogenous carbohydrate oxidation as measured through breath samples during trials 1-3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Endogenous carbohydrate oxidation (Part A)</measure>
    <time_frame>60 min during trials 1-3</time_frame>
    <description>endogenous carbohydrate oxidation as measured through breath samples during trials 1-3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Endogenous carbohydrate oxidation (Part A)</measure>
    <time_frame>90 min during trials 1-3</time_frame>
    <description>endogenous carbohydrate oxidation as measured through breath samples during trials 1-3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Endogenous carbohydrate oxidation (Part A)</measure>
    <time_frame>120 min during trials 1-3</time_frame>
    <description>endogenous carbohydrate oxidation as measured through breath samples during trials 1-3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Endogenous carbohydrate oxidation (Part A)</measure>
    <time_frame>150 min during trials 1-3</time_frame>
    <description>endogenous carbohydrate oxidation as measured through breath samples during trials 1-3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Endogenous carbohydrate oxidation (Part A)</measure>
    <time_frame>180 min during trials 1-3</time_frame>
    <description>endogenous carbohydrate oxidation as measured through breath samples during trials 1-3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glycogen utilization (Part B)</measure>
    <time_frame>3 h post exercise during trials 4-6</time_frame>
    <description>Glycogen utilization measured through a muscle biopsy sample at post (~90 min), 3 and 6 h post exercise.&#xD;
Part B; trials 4-6.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glycogen utilization (Part B)</measure>
    <time_frame>6 h post exercise during trials 4-6</time_frame>
    <description>Glycogen utilization measured through a muscle biopsy sample at post (~90 min), 3 and 6 h post exercise.&#xD;
Part B; trials 4-6.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Indirect calorimetry (Part A)</measure>
    <time_frame>every 30 min up to 180 min during trials 1-3</time_frame>
    <description>Measurements of VO2, VCO2 and RER through indirect calorimetry measured every 30 minutes during trials 1-3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma glucose</measure>
    <time_frame>every 30 min up to 180 min during trials 1-6</time_frame>
    <description>Plasma glucose measurements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma insulin</measure>
    <time_frame>every 30 minutes up to 180 min during trials 1-6</time_frame>
    <description>plasma insulin measurements</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">17</enrollment>
  <condition>Carbohydrate Oxidation and Glycogen Utilization During and Following Exercise</condition>
  <arm_group>
    <arm_group_label>Glucose-glucose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Glucose ingestion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glucose-Fructose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>glucose-fructose ingestion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>disaccharide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Disaccharide ingestion</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Carbohydrate ingestion</intervention_name>
    <description>Various types of carbohydrate ingested during and following exercise</description>
    <arm_group_label>Glucose-Fructose</arm_group_label>
    <arm_group_label>Glucose-glucose</arm_group_label>
    <arm_group_label>disaccharide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  18 - 40 years of age&#xD;
&#xD;
          -  Endurance trained cyclist/triathlete&#xD;
&#xD;
          -  VO2 max ≥ 50 ml/kg/min&#xD;
&#xD;
          -  BMI &lt; 25 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of medication&#xD;
&#xD;
          -  Smoking&#xD;
      </textblock>
    </criteria>
    <gender>Male</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>Luc van Loon, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Naomi Cermak, Ph.D.</last_name>
    <phone>31433881393</phone>
    <email>naomi.cermak@maastrichtuniversity.nl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Maastricht University</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <zip>6200MD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <contact>
      <email>ncermak@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>October 16, 2012</last_update_submitted>
  <last_update_submitted_qc>October 16, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 18, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>carbohydrate, glycogen, glucose</keyword>
  <!-- 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/NCT01709617
org study id: 12-3-048
nct id: NCT01709617
lead sponsor: 
has dmc: No
Carbohydrates are an integral component of sports nutrition. Providing carbohydrate (CHO)
      during exercise delays the onset of fatigue and improves exercise performance by maintaining
      high rates of CHO oxidation. Traditionally, glucose, or glucose polymers have been the
      preferential CHO source found in sports drinks. However, during the intestinal absorption of
      large amounts of glucose (>1.2 g/min), sodium-dependent glucose transporters (SGLT1) may
      become fully saturated, potentially limiting the rate of exogenous CHO oxidation. In an
      effort to evade this limitation, research has suggested using multiple transportable
      carbohydrates in the composition of sports drinks. Multiple transportable carbohydrates are
      combinations of simple sugars that use different intestinal transporters during the
      absorption process. Ingesting multiple transportable carbohydrates may enhance the capacity
      for total intestinal CHO absorption, leading to an increase in the rate of exogenous CHO
      oxidation. Our purpose will be to examine the disaccharide sucrose in it's ability to provide
      exogenous fuel during and following prolonged exercise.
allocation: Randomized
intervention model: Crossover Assignment
masking: Double (Participant, Investigator)
measure: Exogenous carbohydrate oxidation rate (Part A)
time frame: 0 min during trials 1-3
description: Carbohydrate oxidation as measured by breath samples
measure: Endogenous carbohydrate oxidation (Part A)
time frame: 0 min during trials 1-3
description: endogenous carbohydrate oxidation as measured through breath samples during trials 1-3
measure: Glycogen utilization (Part B)
time frame: immediately post exercise (~90min), during trials 4-6
description: Glycogen utilization measured through a muscle biopsy sample at post (~90 min), 3 and 6 h post exercise.
Part B; trials 4-6.
measure: Exogenous carbohydrate oxidation rate (Part A)
time frame: 30 min during trials 1-3
description: Carbohydrate oxidation as measured by breath samples
measure: Exogenous carbohydrate oxidation rate (Part A)
time frame: 60 min during trials 1-3
description: Carbohydrate oxidation as measured by breath samples
measure: Exogenous carbohydrate oxidation rate (Part A)
time frame: 90 min during trials 1-3
description: Carbohydrate oxidation as measured by breath samples
measure: Exogenous carbohydrate oxidation rate (Part A)
time frame: 120 min during trials 1-3
description: Carbohydrate oxidation as measured by breath samples
measure: Exogenous carbohydrate oxidation rate (Part A)
time frame: 150 min during trials 1-3
description: Carbohydrate oxidation as measured by breath samples
measure: Exogenous carbohydrate oxidation rate (Part A)
time frame: 180 min during trials 1-3
description: Carbohydrate oxidation as measured by breath samples
measure: Endogenous carbohydrate oxidation (Part A)
time frame: 30 min during trials 1-3
description: endogenous carbohydrate oxidation as measured through breath samples during trials 1-3
measure: Endogenous carbohydrate oxidation (Part A)
time frame: 60 min during trials 1-3
description: endogenous carbohydrate oxidation as measured through breath samples during trials 1-3
measure: Endogenous carbohydrate oxidation (Part A)
time frame: 90 min during trials 1-3
description: endogenous carbohydrate oxidation as measured through breath samples during trials 1-3
measure: Endogenous carbohydrate oxidation (Part A)
time frame: 120 min during trials 1-3
description: endogenous carbohydrate oxidation as measured through breath samples during trials 1-3
measure: Endogenous carbohydrate oxidation (Part A)
time frame: 150 min during trials 1-3
description: endogenous carbohydrate oxidation as measured through breath samples during trials 1-3
measure: Endogenous carbohydrate oxidation (Part A)
time frame: 180 min during trials 1-3
description: endogenous carbohydrate oxidation as measured through breath samples during trials 1-3
measure: Glycogen utilization (Part B)
time frame: 3 h post exercise during trials 4-6
description: Glycogen utilization measured through a muscle biopsy sample at post (~90 min), 3 and 6 h post exercise.
Part B; trials 4-6.
measure: Glycogen utilization (Part B)
time frame: 6 h post exercise during trials 4-6
description: Glycogen utilization measured through a muscle biopsy sample at post (~90 min), 3 and 6 h post exercise.
Part B; trials 4-6.
measure: Indirect calorimetry (Part A)
time frame: every 30 min up to 180 min during trials 1-3
description: Measurements of VO2, VCO2 and RER through indirect calorimetry measured every 30 minutes during trials 1-3
measure: Plasma glucose
time frame: every 30 min up to 180 min during trials 1-6
description: Plasma glucose measurements
measure: Plasma insulin
time frame: every 30 minutes up to 180 min during trials 1-6
description: plasma insulin measurements
arm group label: Glucose-glucose
arm group type: Experimental
description: Glucose ingestion
arm group label: Glucose-Fructose
arm group type: Active Comparator
description: glucose-fructose ingestion
arm group label: disaccharide
arm group type: Active Comparator
description: Disaccharide ingestion
intervention type: Dietary Supplement
intervention name: Carbohydrate ingestion
description: Various types of carbohydrate ingested during and following exercise
arm group label: Glucose-Fructose
arm group label: Glucose-glucose
arm group label: disaccharide
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Luc van Loon, Ph.D.
role: Principal Investigator
affiliation: Maastricht University
last name: Naomi Cermak, Ph.D.
phone: 31433881393
email: naomi.cermak@maastrichtuniversity.nl
facility: 
contact: 
country: Netherlands
responsible party type: Sponsor