<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/NCT02258399</url>
  </required_header>
  <id_info>
    <org_study_id>RE-FH1109</org_study_id>
    <nct_id>NCT02258399</nct_id>
  </id_info>
  <brief_title>Exercise in the Fasted State, Glucose Metabolism and Energy Balance</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bath</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Stirling</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Birmingham</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Bath</source>
  <brief_summary>
    <textblock>
      The ability to control our blood glucose (sugar) concentrations after a meal is a strong&#xD;
      predictor of the risk of disease. Our bodies respond to glucose ingestion by reducing the&#xD;
      amount of glucose from the liver entering the bloodstream. At the same time muscle increases&#xD;
      the amount of glucose it take up from the bloodstream. This ensures that our blood glucose&#xD;
      levels do not get too high. The investigators want to understand what happens to these&#xD;
      processes following exercise after breakfast and after an overnight fast. In addition, the&#xD;
      investigators also want to understand whether exercising with or without breakfast influences&#xD;
      our appetite, food intake and activity levels later in the day.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2015</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">June 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Exogenous glucose appearance rate</measure>
    <time_frame>120 minutes</time_frame>
    <description>Exogenous glucose appearance rates following an oral glucose tolerance test (total appearance over 120 minutes).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Energy balance</measure>
    <time_frame>24 hours</time_frame>
    <description>Energy balance (intake minus expenditure) over 24 h from the beginning of the trial</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Endogenous glucose appearance rates</measure>
    <time_frame>120 minutes</time_frame>
    <description>Endogenous glucose appearance rates following an oral glucose tolerance test (total appearance over 120 minutes).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose clearance rates</measure>
    <time_frame>120 minutes</time_frame>
    <description>Glucose clearance rates following an oral glucose tolerance test (total clearance over 120 minutes).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Energy intake</measure>
    <time_frame>24 h</time_frame>
    <description>Weighted energy intake over 24 hours from the beginning of the trial.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Energy expenditure</measure>
    <time_frame>24 h</time_frame>
    <description>Energy expenditure, derived from indirect calorimetry, acccelerometry and heart rate monitoring.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exogenous glucose appearance rates</measure>
    <time_frame>120 minutes</time_frame>
    <description>Exogenous glucose appearance rates following an oral glucose tolerance test (total appearance over 120 minutes).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Energy Balance</condition>
  <condition>Blood Glucose</condition>
  <arm_group>
    <arm_group_label>Breakfast Rest</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Breakfast Exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Fasted Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Moderate intensity exercise</description>
    <arm_group_label>Breakfast Exercise</arm_group_label>
    <arm_group_label>Fasted Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Breakfast</intervention_name>
    <description>Breakfast consumption</description>
    <arm_group_label>Breakfast Exercise</arm_group_label>
    <arm_group_label>Breakfast Rest</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males.&#xD;
&#xD;
          -  Aged 18-49.&#xD;
&#xD;
          -  Individuals free from known cardiovascular, metabolic or joint disease as determined&#xD;
             by standard health questionnaire.&#xD;
&#xD;
          -  Habitual regularly participating in exercise (minimum of 3 sessions per week on&#xD;
             average)&#xD;
&#xD;
          -  Non-smoker&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or suspected food intolerances, allergies or hypersensitivity.&#xD;
&#xD;
          -  Any bleeding disorder or taking medication which impacts blood coagulation.&#xD;
&#xD;
          -  Known tendency towards keloid scarring.&#xD;
&#xD;
          -  Known sensitivity or allergy to any local anaesthetic medicines.&#xD;
&#xD;
          -  Any reported use of substances which may pose undue personal risk to participants or&#xD;
             introduce bias into the experiment.&#xD;
&#xD;
          -  Any other condition or behaviour deemed either to pose undue personal risk to&#xD;
             participants or introduce bias into the experiment.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 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>
  <reference>
    <citation>Gonzalez JT. Paradoxical second-meal phenomenon in the acute postexercise period. Nutrition. 2014 Sep;30(9):961-7. doi: 10.1016/j.nut.2013.12.001. Epub 2013 Dec 14.</citation>
    <PMID>24986552</PMID>
  </reference>
  <reference>
    <citation>Gonzalez JT, Veasey RC, Rumbold PL, Stevenson EJ. Breakfast and exercise contingently affect postprandial metabolism and energy balance in physically active males. Br J Nutr. 2013 Aug;110(4):721-32. doi: 10.1017/S0007114512005582. Epub 2013 Jan 29.</citation>
    <PMID>23340006</PMID>
  </reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>March 30, 2018</last_update_submitted>
  <last_update_submitted_qc>March 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Bath</investigator_affiliation>
    <investigator_full_name>Javier Gonzalez</investigator_full_name>
    <investigator_title>Lecturer</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/NCT02258399
org study id: RE-FH1109
nct id: NCT02258399
lead sponsor: 
collaborator: 
collaborator: 
The ability to control our blood glucose (sugar) concentrations after a meal is a strong
      predictor of the risk of disease. Our bodies respond to glucose ingestion by reducing the
      amount of glucose from the liver entering the bloodstream. At the same time muscle increases
      the amount of glucose it take up from the bloodstream. This ensures that our blood glucose
      levels do not get too high. The investigators want to understand what happens to these
      processes following exercise after breakfast and after an overnight fast. In addition, the
      investigators also want to understand whether exercising with or without breakfast influences
      our appetite, food intake and activity levels later in the day.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Exogenous glucose appearance rate
time frame: 120 minutes
description: Exogenous glucose appearance rates following an oral glucose tolerance test (total appearance over 120 minutes).
measure: Energy balance
time frame: 24 hours
description: Energy balance (intake minus expenditure) over 24 h from the beginning of the trial
measure: Endogenous glucose appearance rates
time frame: 120 minutes
description: Endogenous glucose appearance rates following an oral glucose tolerance test (total appearance over 120 minutes).
measure: Glucose clearance rates
time frame: 120 minutes
description: Glucose clearance rates following an oral glucose tolerance test (total clearance over 120 minutes).
measure: Energy intake
time frame: 24 h
description: Weighted energy intake over 24 hours from the beginning of the trial.
measure: Energy expenditure
time frame: 24 h
description: Energy expenditure, derived from indirect calorimetry, acccelerometry and heart rate monitoring.
measure: Exogenous glucose appearance rates
time frame: 120 minutes
description: Exogenous glucose appearance rates following an oral glucose tolerance test (total appearance over 120 minutes).
arm group label: Breakfast Rest
arm group type: Active Comparator
arm group label: Breakfast Exercise
arm group type: Active Comparator
arm group label: Fasted Exercise
arm group type: Experimental
intervention type: Behavioral
intervention name: Exercise
description: Moderate intensity exercise
arm group label: Breakfast Exercise
arm group label: Fasted Exercise
intervention type: Dietary Supplement
intervention name: Breakfast
description: Breakfast consumption
arm group label: Breakfast Exercise
arm group label: Breakfast Rest
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
citation: Gonzalez JT. Paradoxical second-meal phenomenon in the acute postexercise period. Nutrition. 2014 Sep;30(9):961-7. doi: 10.1016/j.nut.2013.12.001. Epub 2013 Dec 14.
PMID: 24986552
citation: Gonzalez JT, Veasey RC, Rumbold PL, Stevenson EJ. Breakfast and exercise contingently affect postprandial metabolism and energy balance in physically active males. Br J Nutr. 2013 Aug;110(4):721-32. doi: 10.1017/S0007114512005582. Epub 2013 Jan 29.
PMID: 23340006
responsible party type: Principal Investigator
investigator affiliation: University of Bath
investigator full name: Javier Gonzalez
investigator title: Lecturer