<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/NCT02251301</url>
  </required_header>
  <id_info>
    <org_study_id>H14-01636</org_study_id>
    <nct_id>NCT02251301</nct_id>
  </id_info>
  <brief_title>Milk Plus Exercise: A Novel Strategy to Treat Diabetes.</brief_title>
  <official_title>The Effect of Adding Milk in Proximity to Exercise During an Interval Training Intervention in Type 2 Diabetes (T2D) on Metabolic and Cardiovascular Health.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dairy Farmers of Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate whether combining interval training with skim&#xD;
      milk supplementation will result in improved glucose control and markers of cardiovascular&#xD;
      health in people with type 2 diabetes. Participants will complete supervised interval&#xD;
      training three times a week over a 12 week training period while consuming skim-milk,&#xD;
      whey/casein protein drink, or a placebo beverage that does not contain any calories or&#xD;
      vitamins/minerals immediately and 1 hour after each training session. After twelve weeks&#xD;
      participants will repeat baseline tests to examine any effects of the intervention on their&#xD;
      glucose control, fitness, blood vessel function, body composition, and blood markers of&#xD;
      inflammation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in glycemic control assessed by continuous glucose monitoring at end of week 12 of intervention</measure>
    <time_frame>Baseline, Week 12.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in hemoglobin A1C percentage at end of week 12 of intervention.</measure>
    <time_frame>Baseline, Week 12.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in fasting plasma glucose concentration at end of week 12 of intervention.</measure>
    <time_frame>Baseline, Week 12.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in fasting plasma insulin concentration at end of week 12 of intervention.</measure>
    <time_frame>Baseline, Week 12.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in flow mediated dilation of brachial artery at end of week 12 of intervention.</measure>
    <time_frame>Baseline, Week 12.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in peak oxygen uptake as a measure of aerobic fitness at end of week 12 of intervention.</measure>
    <time_frame>Baseline, Week 12</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline in fasting plasma non esterified free fatty acid concentration at end of week 12 of intervention.</measure>
    <time_frame>Baseline, Week 12</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in systolic blood pressure at end of week 12 of intervention.</measure>
    <time_frame>Baseline, Week 12</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in diastolic blood pressure at end of week 12 of intervention.</measure>
    <time_frame>Baseline, Week 12.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in circulating inflammatory cytokines at end of week 12 of intervention.</measure>
    <time_frame>Baseline, Week 12.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in body composition as measured by dual absorbancy x ray at end of week 12 of intervention.</measure>
    <time_frame>Baseline, Week 12.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in task switching capabilities at end of week 12 of intervention.</measure>
    <time_frame>Baseline, Week 12.</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Macronutrient isoenergetic control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will also engage in twelve weeks of high intensity interval training with consumption of one serving (250 mL) of macro nutrient matched isoenergetic control (whey/casein protein and dextrose/lactose) consumed immediately and 1 h after each training session</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Skim Milk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will also engage in twelve weeks of High intensity interval training with consumption of one serving (250 mL) of fat-free fluid milk immediately and 1 h after each training session</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will also engage in twelve weeks of high intensity interval training with consumption of one serving (250 mL) of placebo (water) consumed immediately and 1 h after each training session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Skim Milk</intervention_name>
    <description>250 ml skim milk will be consumed by participants immediately and 1 hour after each of the 36 sessions of high-intensity interval training over a 12 week period.</description>
    <arm_group_label>Skim Milk</arm_group_label>
    <other_name>Fat-free milk</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>High intensity interval training</intervention_name>
    <description>All participants will undergo a 12 week high intensity interval training program consisting of 3 supervised sessions a week of 4-10 x 1 min high intensity interval alternating with 1 min of recovery.</description>
    <arm_group_label>Macronutrient isoenergetic control</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Skim Milk</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>250 mL water will be consumed by participants immediately and 1 hour after each of the 36 sessions of high-intensity interval training over a 12 week period.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>water</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Macronutrient isoenergetic control</intervention_name>
    <description>250 mL of protein+cho matched drink will be consumed by participants immediately and 1 hour after each of the 36 sessions of high-intensity interval training over a 12 week period.</description>
    <arm_group_label>Macronutrient isoenergetic control</arm_group_label>
    <other_name>Protein</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 40 and 75.&#xD;
&#xD;
          -  Diagnosed with type 2 diabetes for more than 6 months.&#xD;
&#xD;
          -  On stable medication for the last 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes controlled with exogenous insulin&#xD;
&#xD;
          -  Uncontrolled hypertension (blood pressure &gt;160/90 mmHg)&#xD;
&#xD;
          -  History of heart disease, myocardial infarction or stroke&#xD;
&#xD;
          -  Any other contraindications to exercise&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan P Little, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of British Columbia, Okanagan.</name>
      <address>
        <city>Kelowna</city>
        <state>British Columbia</state>
        <zip>V1V 1V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>May 1, 2017</last_update_submitted>
  <last_update_submitted_qc>May 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 2, 2017</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>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <!-- 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/NCT02251301
org study id: H14-01636
nct id: NCT02251301
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to investigate whether combining interval training with skim
      milk supplementation will result in improved glucose control and markers of cardiovascular
      health in people with type 2 diabetes. Participants will complete supervised interval
      training three times a week over a 12 week training period while consuming skim-milk,
      whey/casein protein drink, or a placebo beverage that does not contain any calories or
      vitamins/minerals immediately and 1 hour after each training session. After twelve weeks
      participants will repeat baseline tests to examine any effects of the intervention on their
      glucose control, fitness, blood vessel function, body composition, and blood markers of
      inflammation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Change from baseline in glycemic control assessed by continuous glucose monitoring at end of week 12 of intervention
time frame: Baseline, Week 12.
measure: Change from baseline in hemoglobin A1C percentage at end of week 12 of intervention.
time frame: Baseline, Week 12.
measure: Change from baseline in fasting plasma glucose concentration at end of week 12 of intervention.
time frame: Baseline, Week 12.
measure: Change from baseline in fasting plasma insulin concentration at end of week 12 of intervention.
time frame: Baseline, Week 12.
measure: Change from baseline in flow mediated dilation of brachial artery at end of week 12 of intervention.
time frame: Baseline, Week 12.
measure: Change from baseline in peak oxygen uptake as a measure of aerobic fitness at end of week 12 of intervention.
time frame: Baseline, Week 12
measure: Change from baseline in fasting plasma non esterified free fatty acid concentration at end of week 12 of intervention.
time frame: Baseline, Week 12
measure: Change from baseline in systolic blood pressure at end of week 12 of intervention.
time frame: Baseline, Week 12
measure: Change from baseline in diastolic blood pressure at end of week 12 of intervention.
time frame: Baseline, Week 12.
measure: Change from baseline in circulating inflammatory cytokines at end of week 12 of intervention.
time frame: Baseline, Week 12.
measure: Change from baseline in body composition as measured by dual absorbancy x ray at end of week 12 of intervention.
time frame: Baseline, Week 12.
measure: Change from baseline in task switching capabilities at end of week 12 of intervention.
time frame: Baseline, Week 12.
arm group label: Macronutrient isoenergetic control
arm group type: Active Comparator
description: Participants will also engage in twelve weeks of high intensity interval training with consumption of one serving (250 mL) of macro nutrient matched isoenergetic control (whey/casein protein and dextrose/lactose) consumed immediately and 1 h after each training session
arm group label: Skim Milk
arm group type: Experimental
description: Participants will also engage in twelve weeks of High intensity interval training with consumption of one serving (250 mL) of fat-free fluid milk immediately and 1 h after each training session
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will also engage in twelve weeks of high intensity interval training with consumption of one serving (250 mL) of placebo (water) consumed immediately and 1 h after each training session.
intervention type: Dietary Supplement
intervention name: Skim Milk
description: 250 ml skim milk will be consumed by participants immediately and 1 hour after each of the 36 sessions of high-intensity interval training over a 12 week period.
arm group label: Skim Milk
other name: Fat-free milk
intervention type: Behavioral
intervention name: High intensity interval training
description: All participants will undergo a 12 week high intensity interval training program consisting of 3 supervised sessions a week of 4-10 x 1 min high intensity interval alternating with 1 min of recovery.
arm group label: Macronutrient isoenergetic control
arm group label: Placebo
arm group label: Skim Milk
intervention type: Other
intervention name: Placebo
description: 250 mL water will be consumed by participants immediately and 1 hour after each of the 36 sessions of high-intensity interval training over a 12 week period.
arm group label: Placebo
other name: water
intervention type: Dietary Supplement
intervention name: Macronutrient isoenergetic control
description: 250 mL of protein+cho matched drink will be consumed by participants immediately and 1 hour after each of the 36 sessions of high-intensity interval training over a 12 week period.
arm group label: Macronutrient isoenergetic control
other name: Protein
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jonathan P Little, PHD
role: Principal Investigator
affiliation: University of British Columbia
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2