<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/NCT03305107</url>
  </required_header>
  <id_info>
    <org_study_id>REB2017- 088</org_study_id>
    <nct_id>NCT03305107</nct_id>
  </id_info>
  <brief_title>High-intensity Interval Exercise and Chocolate Milk on Blood Glucose and Cognition</brief_title>
  <official_title>The Effects of High-intensity Interval Exercise and Chocolate Milk on Glycemic Control and Cognitive Function in Children.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Toronto Metropolitan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Toronto Metropolitan University</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 purpose of this study is to determine the separate and combined effects of high-intensity&#xD;
      interval exercise and chocolate milk on glycemic response, cognitive function, subjective&#xD;
      appetite, and salivary cortisol among children aged 9-13 year old children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twenty children 9-13 years of age will be recruited for this study. On four separate&#xD;
      mornings, after a 10 hour overnight fast, each child will consume a standardized breakfast&#xD;
      (including orange juice, a strawberry breakfast bar and a pear fruit cup) at home. Using a&#xD;
      2x2 factorial design, 2 hours after breakfast consumption, each participant will arrive in&#xD;
      the lab (T=-20 min) and participate in high-intensity interval exercise or sit quietly for 20&#xD;
      min, followed by a treatment drink of chocolate milk or water (control) consumption in 10&#xD;
      min. During high-intensity interval exercise treatment, children will exercise on a cycle&#xD;
      ergometer with a 3-min warm-up, 7 repeated bouts of 60-sec exercise at 90% of peak power&#xD;
      output and 60-second recovery, and a 3-min cool down. Blood glucose will be measured via&#xD;
      finger-prick at baseline (-20 min), 10, 30, 60, and 90 min. Cognitive functions will be&#xD;
      measured using a battery of cognitive tests which assess verbal declarative memory, working&#xD;
      memory, and executive functioning, and will be measured at baseline, 10. 30. 60, and 90 min.&#xD;
      Subjective appetite and emotions will be measured using a 100-mm visual analogue scale (VAS)&#xD;
      at baseline, 10, 30, 60, and 90 min. Salivary cortisol will be assessed from saliva samples&#xD;
      collected using the passive drool method, and will be collected at baseline, 10 and 30 min.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 8, 2017</start_date>
  <completion_date type="Actual">May 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline Glycemic Response</measure>
    <time_frame>baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption</time_frame>
    <description>Blood samples will be collected via finger-prick method to assess glycemic response (blood glucose, mmol/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline verbal declarative memory</measure>
    <time_frame>baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption</time_frame>
    <description>Cognitive function test of verbal declarative memory</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline working memory</measure>
    <time_frame>baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption</time_frame>
    <description>The n-back test consists of 2 levels, 1-back and 2-back, where letters are presented on the screen one at a time. During the 1-back level, participants need to determine if the presented letter is the same as the one letter presented 1 before it or not (by selected 'match' or 'no match' on the side of the screen) and during 2-back need to do determine if it is the same letter as the one presented 2 letters prior.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline executive functioning</measure>
    <time_frame>baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption</time_frame>
    <description>The Stroop test consists of one word appearing on the screen written in either blue, red, yellow or green. There are 24 congruent trials where the presented word is the name of the colour it is written it (i.e. 'red' appearing in the colour red), 24 incongruent trials where the word written is a colour word different from the one it is written in (i.e. 'red' appearing in the colour green), and 10 neutral trials where non-colour words appear (i.e. 'tape' appearing in yellow). The participant is asked to tap the corresponding colour that the word is written in as quickly as possible.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline salivary cortisol response</measure>
    <time_frame>baseline (-20 min), and 10 and 30 min post-drink consumption</time_frame>
    <description>Saliva samples will be collected via passive drool method to assess salivary cortisol response (ug/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change form baseline Subjective Appetite</measure>
    <time_frame>baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption</time_frame>
    <description>100-mm Visual Analogue Scales (VAS) will be used to assess appetite</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline aggression</measure>
    <time_frame>baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption</time_frame>
    <description>100-mm Visual Analogue Scales (VAS) will be used to assess aggression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline anger</measure>
    <time_frame>baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption</time_frame>
    <description>100-mm Visual Analogue Scales (VAS) will be used to assess anger</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline excitement</measure>
    <time_frame>baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption</time_frame>
    <description>100-mm Visual Analogue Scales (VAS) will be used to assess excitement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline disappointment</measure>
    <time_frame>baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption</time_frame>
    <description>100-mm Visual Analogue Scales (VAS) will be used to assess disappointment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline happiness</measure>
    <time_frame>baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption</time_frame>
    <description>100-mm Visual Analogue Scales (VAS) will be used to assess happiness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline upset</measure>
    <time_frame>baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption</time_frame>
    <description>100-mm Visual Analogue Scales (VAS) will be used to assess upset</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change form baseline frustration</measure>
    <time_frame>baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption</time_frame>
    <description>100-mm Visual Analogue Scales (VAS) will be used to assess frustration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline alertness</measure>
    <time_frame>baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption</time_frame>
    <description>100-mm Visual Analogue Scales (VAS) will be used to assess alertness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline sadness</measure>
    <time_frame>baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption</time_frame>
    <description>100-mm Visual Analogue Scales (VAS) will be used to assess sadness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline tension</measure>
    <time_frame>baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption</time_frame>
    <description>100-mm Visual Analogue Scales (VAS) will be used to assess tension</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline exhaustion</measure>
    <time_frame>baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption</time_frame>
    <description>100-mm Visual Analogue Scales (VAS) will be used to assess exhaustion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline sleepiness</measure>
    <time_frame>baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption</time_frame>
    <description>100-mm Visual Analogue Scales (VAS) will be used to assess sleepiness</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Glycemic Response</condition>
  <condition>Cognitive Function</condition>
  <arm_group>
    <arm_group_label>Exercise and Chocolate Milk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children will exercise on a cycle ergometer with a 3-min warm-up, 7 repeated bouts of 60-sec exercise at 90% of peak power output and 60-second recovery, and a 3-min cool down.&#xD;
Children will then drink 240mL of chocolate milk</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise and Water</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children will exercise on a cycle ergometer with a 3-min warm-up, 7 repeated bouts of 60-sec exercise at 90% of peak power output and 60-second recovery, and a 3-min cool down.&#xD;
Children will then drink 240mL of water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sitting and Chocolate Milk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children will quietly sit for 20 minutes Children will then drink 240mL of chocolate milk</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sitting and Water</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children will quietly sit for 20 minutes Children will then drink 240mL of water</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise and Chocolate Milk</intervention_name>
    <description>High intensity interval exercise Chocolate Milk</description>
    <arm_group_label>Exercise and Chocolate Milk</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise and Water</intervention_name>
    <description>High intensity interval exercise Water</description>
    <arm_group_label>Exercise and Water</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sitting and Chocolate Milk</intervention_name>
    <description>Sitting Chocolate Milk</description>
    <arm_group_label>Sitting and Chocolate Milk</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sitting and Water</intervention_name>
    <description>Sitting Water</description>
    <arm_group_label>Sitting and Water</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  be between 9 and 13 years of age&#xD;
&#xD;
          -  be healthy, and have been born at term&#xD;
&#xD;
          -  not be taking any medications&#xD;
&#xD;
          -  not have allergies to dairy or gluten.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Food sensitivities, allergies, or dietary restrictions&#xD;
&#xD;
          -  Health, learning, emotional, or behavioural problems&#xD;
&#xD;
          -  Receiving any medications&#xD;
&#xD;
          -  Non-habitual breakfast eater (&lt;5 days/week)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nick Bellissimo, PHD</last_name>
    <role>Study Director</role>
    <affiliation>School of Nutrition, Ryerson University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School of Nutrition, Ryerson University</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 2K3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>August 9, 2018</last_update_submitted>
  <last_update_submitted_qc>August 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Toronto Metropolitan University</investigator_affiliation>
    <investigator_full_name>Nick Bellissimo</investigator_full_name>
    <investigator_title>Study Director</investigator_title>
  </responsible_party>
  <keyword>Child</keyword>
  <keyword>Exercise</keyword>
  <keyword>Chocolate milk</keyword>
  <keyword>Blood glucose</keyword>
  <keyword>Cognition</keyword>
  <keyword>Appetite</keyword>
  <keyword>Emotions</keyword>
  <keyword>Cortisol</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03305107
org study id: REB2017- 088
nct id: NCT03305107
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine the separate and combined effects of high-intensity
      interval exercise and chocolate milk on glycemic response, cognitive function, subjective
      appetite, and salivary cortisol among children aged 9-13 year old children.
Twenty children 9-13 years of age will be recruited for this study. On four separate
      mornings, after a 10 hour overnight fast, each child will consume a standardized breakfast
      (including orange juice, a strawberry breakfast bar and a pear fruit cup) at home. Using a
      2x2 factorial design, 2 hours after breakfast consumption, each participant will arrive in
      the lab (T=-20 min) and participate in high-intensity interval exercise or sit quietly for 20
      min, followed by a treatment drink of chocolate milk or water (control) consumption in 10
      min. During high-intensity interval exercise treatment, children will exercise on a cycle
      ergometer with a 3-min warm-up, 7 repeated bouts of 60-sec exercise at 90% of peak power
      output and 60-second recovery, and a 3-min cool down. Blood glucose will be measured via
      finger-prick at baseline (-20 min), 10, 30, 60, and 90 min. Cognitive functions will be
      measured using a battery of cognitive tests which assess verbal declarative memory, working
      memory, and executive functioning, and will be measured at baseline, 10. 30. 60, and 90 min.
      Subjective appetite and emotions will be measured using a 100-mm visual analogue scale (VAS)
      at baseline, 10, 30, 60, and 90 min. Salivary cortisol will be assessed from saliva samples
      collected using the passive drool method, and will be collected at baseline, 10 and 30 min.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change from baseline Glycemic Response
time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
description: Blood samples will be collected via finger-prick method to assess glycemic response (blood glucose, mmol/L)
measure: Change from baseline verbal declarative memory
time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
description: Cognitive function test of verbal declarative memory
measure: Change from baseline working memory
time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
description: The n-back test consists of 2 levels, 1-back and 2-back, where letters are presented on the screen one at a time. During the 1-back level, participants need to determine if the presented letter is the same as the one letter presented 1 before it or not (by selected 'match' or 'no match' on the side of the screen) and during 2-back need to do determine if it is the same letter as the one presented 2 letters prior.
measure: Change from baseline executive functioning
time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
description: The Stroop test consists of one word appearing on the screen written in either blue, red, yellow or green. There are 24 congruent trials where the presented word is the name of the colour it is written it (i.e. 'red' appearing in the colour red), 24 incongruent trials where the word written is a colour word different from the one it is written in (i.e. 'red' appearing in the colour green), and 10 neutral trials where non-colour words appear (i.e. 'tape' appearing in yellow). The participant is asked to tap the corresponding colour that the word is written in as quickly as possible.
measure: Change from baseline salivary cortisol response
time frame: baseline (-20 min), and 10 and 30 min post-drink consumption
description: Saliva samples will be collected via passive drool method to assess salivary cortisol response (ug/dL)
measure: Change form baseline Subjective Appetite
time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
description: 100-mm Visual Analogue Scales (VAS) will be used to assess appetite
measure: Change from baseline aggression
time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
description: 100-mm Visual Analogue Scales (VAS) will be used to assess aggression
measure: Change from baseline anger
time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
description: 100-mm Visual Analogue Scales (VAS) will be used to assess anger
measure: Change from baseline excitement
time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
description: 100-mm Visual Analogue Scales (VAS) will be used to assess excitement
measure: Change from baseline disappointment
time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
description: 100-mm Visual Analogue Scales (VAS) will be used to assess disappointment
measure: Change from baseline happiness
time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
description: 100-mm Visual Analogue Scales (VAS) will be used to assess happiness
measure: Change from baseline upset
time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
description: 100-mm Visual Analogue Scales (VAS) will be used to assess upset
measure: Change form baseline frustration
time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
description: 100-mm Visual Analogue Scales (VAS) will be used to assess frustration
measure: Change from baseline alertness
time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
description: 100-mm Visual Analogue Scales (VAS) will be used to assess alertness
measure: Change from baseline sadness
time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
description: 100-mm Visual Analogue Scales (VAS) will be used to assess sadness
measure: Change from baseline tension
time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
description: 100-mm Visual Analogue Scales (VAS) will be used to assess tension
measure: Change from baseline exhaustion
time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
description: 100-mm Visual Analogue Scales (VAS) will be used to assess exhaustion
measure: Change from baseline sleepiness
time frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
description: 100-mm Visual Analogue Scales (VAS) will be used to assess sleepiness
arm group label: Exercise and Chocolate Milk
arm group type: Experimental
description: Children will exercise on a cycle ergometer with a 3-min warm-up, 7 repeated bouts of 60-sec exercise at 90% of peak power output and 60-second recovery, and a 3-min cool down.
Children will then drink 240mL of chocolate milk
arm group label: Exercise and Water
arm group type: Experimental
description: Children will exercise on a cycle ergometer with a 3-min warm-up, 7 repeated bouts of 60-sec exercise at 90% of peak power output and 60-second recovery, and a 3-min cool down.
Children will then drink 240mL of water
arm group label: Sitting and Chocolate Milk
arm group type: Experimental
description: Children will quietly sit for 20 minutes Children will then drink 240mL of chocolate milk
arm group label: Sitting and Water
arm group type: Experimental
description: Children will quietly sit for 20 minutes Children will then drink 240mL of water
intervention type: Other
intervention name: Exercise and Chocolate Milk
description: High intensity interval exercise Chocolate Milk
arm group label: Exercise and Chocolate Milk
intervention type: Other
intervention name: Exercise and Water
description: High intensity interval exercise Water
arm group label: Exercise and Water
intervention type: Other
intervention name: Sitting and Chocolate Milk
description: Sitting Chocolate Milk
arm group label: Sitting and Chocolate Milk
intervention type: Other
intervention name: Sitting and Water
description: Sitting Water
arm group label: Sitting and Water
criteria: 
gender: All
minimum age: 9 Years
maximum age: 13 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nick Bellissimo, PHD
role: Study Director
affiliation: School of Nutrition, Ryerson University
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Toronto Metropolitan University
investigator full name: Nick Bellissimo
investigator title: Study Director
sharing ipd: No