<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/NCT02258438</url>
  </required_header>
  <id_info>
    <org_study_id>14-0429</org_study_id>
    <secondary_id>UL1TR001082</secondary_id>
    <nct_id>NCT02258438</nct_id>
  </id_info>
  <brief_title>Effect of Breaking up Prolonged Sitting on Metabolic Flexibility</brief_title>
  <official_title>Effect of Breaking up Prolonged Sitting on Metabolic Flexibility</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators propose in this project to determine the effect of 3 days of frequent&#xD;
      interruption of prolonged sitting on metabolic health in healthy overweight sedentary adults&#xD;
      (n=24), as compared to 3 days including a single long bout of isocaloric exercise or a&#xD;
      control condition where subjects do not exercise but are subjected to prolonged sitting. The&#xD;
      investigators believe that this proposed project will provide an initial evidence base for&#xD;
      the health benefits of breaking up prolonged sitting with short bursts of moderate-intensity&#xD;
      activity, like walking.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although public-health recommendations to engage in moderate-to-vigorous physical activity&#xD;
      (at least 30min, 5 days / week) have been widely promulgated by the government, most people&#xD;
      are physically inactive. Sedentary behaviors, like time spent sitting, are associated with&#xD;
      serious implications on metabolic health, indicating that even in individuals who regularly&#xD;
      exercise a reduction in time spent sitting can confer health benefits. Encouraging recent&#xD;
      evidence shows that walking breaks throughout the day are an effective strategy to offset the&#xD;
      deleterious effects of prolonged uninterrupted sitting. Further data however are needed to&#xD;
      better understand the effect of these microbursts of activity along the day. The&#xD;
      investigators propose in this project to determine the effect of 3 days of frequent&#xD;
      interruption of prolonged sitting on metabolic health in healthy overweight sedentary adults&#xD;
      (n=24), as compared to 3 days including a single long bout of isocaloric exercise or a&#xD;
      control condition where subjects do not exercise but are subjected to prolonged sitting.&#xD;
      Plasma glucose, insulin, triglycerides and free fatty acids concentrations and the use of&#xD;
      substrate (glucose, fat or protein) to provide energy to the body in response to meals&#xD;
      consumption will be measured on day 3 of each of these three conditions. The investigators&#xD;
      will furthermore assess the ability of the participants to perform the interventions on&#xD;
      physical activity at the end of each day over the three days of intervention (2 days in&#xD;
      free-living conditions and one day in a controlled environment). The investigators believe&#xD;
      that this proposed project will provide an initial evidence base for the health benefits of&#xD;
      breaking up prolonged sitting with short bursts of moderate-intensity activity, like walking.&#xD;
      This innovative strategy may be more effective at combating the adverse effects of sedentary&#xD;
      behaviors than more traditional approaches like structured exercise.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 8, 2014</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">September 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>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total substrate oxidation</measure>
    <time_frame>1 day</time_frame>
    <description>Total fat oxidation during the test day will be determined using whole-room indirect calorimetry. O2 consumption and CO2 production will be determined from the flow rates and differences in gas concentrations between air entering and air exiting the calorimeter as previously described</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postprandial plasma insulin and glucose response</measure>
    <time_frame>1 day</time_frame>
    <description>Plasma glucose and insulin will be measured in fasting conditions and hourly during 12hrs following a standard meal consumption. The area under the curve will be calculated for both plasma glucose and insulin. This area will represent the postprandial response to a meal for both insulin and glucose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dietary fat oxidation</measure>
    <time_frame>1 day</time_frame>
    <description>Subjects will collect their own hourly breath sampling for 13CO2 by blowing through a straw into two 15ml Vacutainer after the investigators will have shown them the procedure. Breath CO2 will be sampled directly from the Vacutainer with a syringe, and 13CO2 /12CO2 measured with Isotopic Ratio Mass Spectrometer (IRMS).</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Health Behavior</condition>
  <arm_group>
    <arm_group_label>Uninterrupted sitting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient will refrain from any structured activity and reduce any daily life activity. The patient will spend 24 hours in the calorimeter room. During the 24 hours the patient will remain sedentary for the 24 hours but will be able to watch TV, computer work or read.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sitting + 1 bout of activity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patient will be asked to perform the 45 minutes of moderate-exercise intervention in the morning once per day for two days in their daily life. This bout of exercise will be supervised by study staff on one of the treadmills On day 3 the patient will report at the Clinical and Translational Research Center (CTRC) of the University Hospital of Colorado and will spend 24hr in the room calorimeter. During the day, you will be asked to sit quietly in a chair, except to rise from the chair to void, and to perform one bout of 45-min moderate-intensity walking on a treadmill.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sitting + microbursts of activity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patient will be asked to refrain from any structured exercise running, swimming, lifting weights, yoga, dancing, etc.) for two days but to walk for the 5 minute intervention each hour between 1000 and 1800. On day 3, The patient will report at the CTRC of the University Hospital of Colorado and will spend 24hr in the room calorimeter. During the day, the patient will be asked to rise from the seated position every hour for 9 hours from 1000 to 1800 to complete 5 min moderate-intensity walking on a treadmill, which represents a total of 45 min.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Uninterrupted sitting</intervention_name>
    <description>Subjects will be asked to refrain for two days from any structured activity and to reduce any daily life activity (walking, taking the stairs, biking, etc.) in their daily life. On day 3, subjects will remain seated all day in the room calorimeter, except to rise from the chair to void.</description>
    <arm_group_label>Uninterrupted sitting</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sitting + 1 bout of activity</intervention_name>
    <description>Subjects will be asked to perform 45 minutes of moderate-exercise in the morning once per day for two days in their daily life. On day 3 they will remain seated all day in the room calorimeter, except to rise from the chair to void, and to perform one bout of 45-min moderate-intensity (defined below) walking on a treadmill at 1000.</description>
    <arm_group_label>Sitting + 1 bout of activity</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sitting + microbursts of activity</intervention_name>
    <description>Subjects will be asked to refrain from any structured exercise for two days but to walk for 5 minutes each hour between 1000 and 1800 in daily life. On day 3, subjects will rise from the seated position every hour for 9 hours from 1000 to 1800 to complete 5min moderate-intensity (defined below) walking on a treadmill, which represents a total of 45min.</description>
    <arm_group_label>Sitting + microbursts of activity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  overweight but weight stable (less than +/- 3kg over previous 6 months) male and&#xD;
             female adults (n=24) will be recruited.&#xD;
&#xD;
          -  age between 19-45 years old,&#xD;
&#xD;
          -  a BMI of 27-33 kg/m2,&#xD;
&#xD;
          -  inactive (≤ 1.5hr/wk of moderate-to-vigorous activity),&#xD;
&#xD;
          -  sedentary (office employees who are spending more than 6hrs/day in sitting position)&#xD;
             and&#xD;
&#xD;
          -  English-speaking.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any history of renal, cardiovascular or hepatic diseases,&#xD;
&#xD;
          -  type 1 or 2 diabetes,&#xD;
&#xD;
          -  cancer,&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  smoking,&#xD;
&#xD;
          -  consumption of drugs or alcohol (&gt;40g/d),&#xD;
&#xD;
          -  any medications known to interfere with lipid or energy metabolism,&#xD;
&#xD;
          -  known physical activity contraindications, or major illness/physical problems (acute&#xD;
             or chronic) that may limit their ability to perform the walking activities and&#xD;
&#xD;
          -  menopause (defined as no menses in the prior 6 months). The use of birth pill control&#xD;
             will be accepted. Women are asked to avoid pregnancy until completion of Condition C.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Audrey Bergouignan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</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>April 29, 2021</last_update_submitted>
  <last_update_submitted_qc>April 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sedentary Behavior</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/NCT02258438
org study id: 14-0429
secondary id: UL1TR001082
nct id: NCT02258438
lead sponsor: 
has dmc: No
The investigators propose in this project to determine the effect of 3 days of frequent
      interruption of prolonged sitting on metabolic health in healthy overweight sedentary adults
      (n=24), as compared to 3 days including a single long bout of isocaloric exercise or a
      control condition where subjects do not exercise but are subjected to prolonged sitting. The
      investigators believe that this proposed project will provide an initial evidence base for
      the health benefits of breaking up prolonged sitting with short bursts of moderate-intensity
      activity, like walking.
Although public-health recommendations to engage in moderate-to-vigorous physical activity
      (at least 30min, 5 days / week) have been widely promulgated by the government, most people
      are physically inactive. Sedentary behaviors, like time spent sitting, are associated with
      serious implications on metabolic health, indicating that even in individuals who regularly
      exercise a reduction in time spent sitting can confer health benefits. Encouraging recent
      evidence shows that walking breaks throughout the day are an effective strategy to offset the
      deleterious effects of prolonged uninterrupted sitting. Further data however are needed to
      better understand the effect of these microbursts of activity along the day. The
      investigators propose in this project to determine the effect of 3 days of frequent
      interruption of prolonged sitting on metabolic health in healthy overweight sedentary adults
      (n=24), as compared to 3 days including a single long bout of isocaloric exercise or a
      control condition where subjects do not exercise but are subjected to prolonged sitting.
      Plasma glucose, insulin, triglycerides and free fatty acids concentrations and the use of
      substrate (glucose, fat or protein) to provide energy to the body in response to meals
      consumption will be measured on day 3 of each of these three conditions. The investigators
      will furthermore assess the ability of the participants to perform the interventions on
      physical activity at the end of each day over the three days of intervention (2 days in
      free-living conditions and one day in a controlled environment). The investigators believe
      that this proposed project will provide an initial evidence base for the health benefits of
      breaking up prolonged sitting with short bursts of moderate-intensity activity, like walking.
      This innovative strategy may be more effective at combating the adverse effects of sedentary
      behaviors than more traditional approaches like structured exercise.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Total substrate oxidation
time frame: 1 day
description: Total fat oxidation during the test day will be determined using whole-room indirect calorimetry. O2 consumption and CO2 production will be determined from the flow rates and differences in gas concentrations between air entering and air exiting the calorimeter as previously described
measure: Postprandial plasma insulin and glucose response
time frame: 1 day
description: Plasma glucose and insulin will be measured in fasting conditions and hourly during 12hrs following a standard meal consumption. The area under the curve will be calculated for both plasma glucose and insulin. This area will represent the postprandial response to a meal for both insulin and glucose.
measure: Dietary fat oxidation
time frame: 1 day
description: Subjects will collect their own hourly breath sampling for 13CO2 by blowing through a straw into two 15ml Vacutainer after the investigators will have shown them the procedure. Breath CO2 will be sampled directly from the Vacutainer with a syringe, and 13CO2 /12CO2 measured with Isotopic Ratio Mass Spectrometer (IRMS).
arm group label: Uninterrupted sitting
arm group type: Experimental
description: Patient will refrain from any structured activity and reduce any daily life activity. The patient will spend 24 hours in the calorimeter room. During the 24 hours the patient will remain sedentary for the 24 hours but will be able to watch TV, computer work or read.
arm group label: Sitting + 1 bout of activity
arm group type: Experimental
description: The patient will be asked to perform the 45 minutes of moderate-exercise intervention in the morning once per day for two days in their daily life. This bout of exercise will be supervised by study staff on one of the treadmills On day 3 the patient will report at the Clinical and Translational Research Center (CTRC) of the University Hospital of Colorado and will spend 24hr in the room calorimeter. During the day, you will be asked to sit quietly in a chair, except to rise from the chair to void, and to perform one bout of 45-min moderate-intensity walking on a treadmill.
arm group label: Sitting + microbursts of activity
arm group type: Experimental
description: The patient will be asked to refrain from any structured exercise running, swimming, lifting weights, yoga, dancing, etc.) for two days but to walk for the 5 minute intervention each hour between 1000 and 1800. On day 3, The patient will report at the CTRC of the University Hospital of Colorado and will spend 24hr in the room calorimeter. During the day, the patient will be asked to rise from the seated position every hour for 9 hours from 1000 to 1800 to complete 5 min moderate-intensity walking on a treadmill, which represents a total of 45 min.
intervention type: Behavioral
intervention name: Uninterrupted sitting
description: Subjects will be asked to refrain for two days from any structured activity and to reduce any daily life activity (walking, taking the stairs, biking, etc.) in their daily life. On day 3, subjects will remain seated all day in the room calorimeter, except to rise from the chair to void.
arm group label: Uninterrupted sitting
intervention type: Behavioral
intervention name: Sitting + 1 bout of activity
description: Subjects will be asked to perform 45 minutes of moderate-exercise in the morning once per day for two days in their daily life. On day 3 they will remain seated all day in the room calorimeter, except to rise from the chair to void, and to perform one bout of 45-min moderate-intensity (defined below) walking on a treadmill at 1000.
arm group label: Sitting + 1 bout of activity
intervention type: Behavioral
intervention name: Sitting + microbursts of activity
description: Subjects will be asked to refrain from any structured exercise for two days but to walk for 5 minutes each hour between 1000 and 1800 in daily life. On day 3, subjects will rise from the seated position every hour for 9 hours from 1000 to 1800 to complete 5min moderate-intensity (defined below) walking on a treadmill, which represents a total of 45min.
arm group label: Sitting + microbursts of activity
criteria: 
gender: All
minimum age: 19 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Audrey Bergouignan, PhD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No