<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/NCT04499287</url>
  </required_header>
  <id_info>
    <org_study_id>OxPMW</org_study_id>
    <nct_id>NCT04499287</nct_id>
  </id_info>
  <brief_title>Mealtime Walking Study to Improve Postprandial Metabolic Response</brief_title>
  <official_title>Mealtime Walking Study to Improve Postprandial Metabolic Response</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arizona State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Arizona State 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>
      This randomized crossover trial will investigate the metabolic responses following the&#xD;
      consumption of a bagel+juice meal under 3 conditions: control, fiber (positive control), and&#xD;
      postmeal walk in15 healthy adults. It is hypothesized that the postmeal walk will reduce&#xD;
      glycemia, insulinemia, and oxidative stress similar to fiber.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will follow a randomized, crossover design. Participants and the investigator will&#xD;
      be blinded for the control treatments but not for the walk treatment. Participants will&#xD;
      complete 3 meal tests; tests are separated by about 1 week. An initial screening visit will&#xD;
      be scheduled for the online survey respondents that meet the inclusion criteria and are&#xD;
      willing to consider participation. At this visit, written consent will be secured followed by&#xD;
      further screening for the exclusion criteria and the collection of demographic and health&#xD;
      history data and anthropometric measures. A fasting blood sample will be collected for&#xD;
      glucose analysis. Participants will be scheduled for experimental testing and provided with&#xD;
      instructions and calendars. Participants will be given at least one week's notice if they do&#xD;
      not qualify for the trial based on fasting glucose concentrations.&#xD;
&#xD;
      On the day prior to each experimental day, the participants will consume 2 bagels (54 g&#xD;
      carbohydrate/bagel), and on the night prior to each visit, participants will consume a&#xD;
      standard dinner of their choice. (The bagels will be provided to participants and the&#xD;
      standardized dinner will be documented. The bagels and standardized dinner meal will&#xD;
      facilitate controlled 'glycogen loading' prior to testing.) No other food will be consumed&#xD;
      after this dinner meal, and participants will fast overnight until they arrive at the&#xD;
      research center the next morning (e.g., no food or beverage with the exception of water).&#xD;
      Fasting blood (1 tablespoon) will be collected and the test meal (bagel+juice) will be&#xD;
      consumed. Postprandial blood samples will be collected for 4 hours (see below). The subjects&#xD;
      will not be allowed to consume any food or beverage (with the exception of water) through the&#xD;
      duration the visit. A snack will be provided to participants once the testing is over.&#xD;
&#xD;
      Glucose: 0,15,30,60,120, 180, 240 Insulin: 0, 30, 120, 180, 240 Oxidative Stress Markers: 0,&#xD;
      180, 240&#xD;
&#xD;
      The blood insulin level will be determined in venous blood by RIA. Capillary blood glucose&#xD;
      will be determined with a glucometer. Oxidative stress, e.g., total antioxidant capacity,&#xD;
      IL-6, and TBARS will be assessed using microplate analyses kits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 17, 2014</start_date>
  <completion_date type="Actual">March 10, 2015</completion_date>
  <primary_completion_date type="Actual">February 14, 2015</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>
    <intervention_model_description>randomized, controlled, crossover</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postprandial glycemia</measure>
    <time_frame>4 hours</time_frame>
    <description>incremental area under curve</description>
  </primary_outcome>
  <primary_outcome>
    <measure>postprandial insulinemia</measure>
    <time_frame>4 hours</time_frame>
    <description>incremental area under curve</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>postprandial oxidative stress</measure>
    <time_frame>4 hours</time_frame>
    <description>total antioxidant capacity of blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postprandial oxidative stress</measure>
    <time_frame>4 hours</time_frame>
    <description>blood interleukin-6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postprandial oxidative stress</measure>
    <time_frame>4 hours</time_frame>
    <description>Thiobarbituric Acid Reactive Substances TBARS</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>PreDiabetes</condition>
  <condition>Postprandial Hyperglycemia</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Test meal [bagel with butter (20 g) and apple juice (240 ml) with added sugar (24 g)] The meal was a total of 640 kcal (100 g carbohydrate, 21 g fat, 10 g protein. Participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption. One week later the test meal was consumed with fiber (36 g, Metamucil powder, Procter&amp;Gamble, Cincinnati, OH) added to the apple juice (active) and participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption . One week later participants were given 5 minutes to transition to the treadmill following consumption of the test meal and began walking on a motorized treadmill at their calculated preferred walking speed for 15 minutes (experimental). Afterwards participants remained seated in the laboratory with minimal activity for the remainder of the four hours following test meal consumption</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fiber</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Test meal [bagel with butter (20 g) and apple juice (240 ml) with added sugar (24 g)] The meal was a total of 640 kcal (100 g carbohydrate, 21 g fat, 10 g protein. 9 grams of soluble viscous fiber from psyllium husk (36 g, Metamucil powder, Procter&amp;Gamble, Cincinnati, OH) was mixed with the apple juice. Participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption. One week later participants were given 5 minutes to transition to the treadmill following consumption of the test meal and began walking on a motorized treadmill at their calculated preferred walking speed for 15 minutes (experimental). Afterwards participants remained seated in the laboratory with minimal activity for the remainder of the four hours following test meal consumption. One week later the test meal was consumed, and participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption (placebo).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Walk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test meal [bagel with butter (20 g) and apple juice (240 ml) with added sugar (24 g)] The meal was a total of 640 kcal (100 g carbohydrate, 21 g fat, 10 g protein. Participants were given 5 minutes to transition to the treadmill following consumption of the test meal and began walking on a motorized treadmill at their calculated preferred walking speed for 15 minutes. Afterwards participants remained seated in the laboratory with minimal activity for the remainder of the four hours following test meal consumption One week later the test meal was consumed, and participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption (placebo comparator). One week later the test meal was consumed with fiber (36 g, Metamucil powder, Procter&amp;Gamble, Cincinnati, OH) added to the apple juice and participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption (active comparator).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>15-minute walk at preferred walking speed.</intervention_name>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Fiber</arm_group_label>
    <arm_group_label>Walk</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fiber</intervention_name>
    <description>9 grams soluble fiber</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Fiber</arm_group_label>
    <arm_group_label>Walk</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>control</intervention_name>
    <description>control</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Fiber</arm_group_label>
    <arm_group_label>Walk</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  obese (BMI ≥ 30 kg/m2)&#xD;
&#xD;
          -  nonsmoking&#xD;
&#xD;
          -  sedentary&#xD;
&#xD;
          -  fasting capillary blood glucose that measured from 5.6 to 6.9 mmol/L&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  answered &quot;yes&quot; to any of the questions on the &quot;Par-Q &amp; You&quot; questionnaire&#xD;
&#xD;
          -  refused to discontinue antioxidant supplement use for several weeks prior to and&#xD;
             during the study&#xD;
&#xD;
          -  prescribed medication use (unless use was consistent for the 3 months prior to the&#xD;
             study and intake remained consistent throughout the study duration)&#xD;
&#xD;
          -  food allergies or medical conditions that impacted normal functioning of the&#xD;
             gastrointestinal tract&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>July 19, 2021</last_update_submitted>
  <last_update_submitted_qc>July 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Arizona State University</investigator_affiliation>
    <investigator_full_name>Carol Johnston</investigator_full_name>
    <investigator_title>Professor and Associate Dean</investigator_title>
  </responsible_party>
  <keyword>blood glucose</keyword>
  <keyword>blood insulin</keyword>
  <keyword>fiber</keyword>
  <keyword>prediabetes</keyword>
  <keyword>postprandial glycemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperglycemia</mesh_term>
    <mesh_term>Prediabetic State</mesh_term>
    <mesh_term>Glucose Intolerance</mesh_term>
  </condition_browse>
  <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/NCT04499287
org study id: OxPMW
nct id: NCT04499287
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This randomized crossover trial will investigate the metabolic responses following the
      consumption of a bagel+juice meal under 3 conditions: control, fiber (positive control), and
      postmeal walk in15 healthy adults. It is hypothesized that the postmeal walk will reduce
      glycemia, insulinemia, and oxidative stress similar to fiber.
The study will follow a randomized, crossover design. Participants and the investigator will
      be blinded for the control treatments but not for the walk treatment. Participants will
      complete 3 meal tests; tests are separated by about 1 week. An initial screening visit will
      be scheduled for the online survey respondents that meet the inclusion criteria and are
      willing to consider participation. At this visit, written consent will be secured followed by
      further screening for the exclusion criteria and the collection of demographic and health
      history data and anthropometric measures. A fasting blood sample will be collected for
      glucose analysis. Participants will be scheduled for experimental testing and provided with
      instructions and calendars. Participants will be given at least one week's notice if they do
      not qualify for the trial based on fasting glucose concentrations.

      On the day prior to each experimental day, the participants will consume 2 bagels (54 g
      carbohydrate/bagel), and on the night prior to each visit, participants will consume a
      standard dinner of their choice. (The bagels will be provided to participants and the
      standardized dinner will be documented. The bagels and standardized dinner meal will
      facilitate controlled 'glycogen loading' prior to testing.) No other food will be consumed
      after this dinner meal, and participants will fast overnight until they arrive at the
      research center the next morning (e.g., no food or beverage with the exception of water).
      Fasting blood (1 tablespoon) will be collected and the test meal (bagel+juice) will be
      consumed. Postprandial blood samples will be collected for 4 hours (see below). The subjects
      will not be allowed to consume any food or beverage (with the exception of water) through the
      duration the visit. A snack will be provided to participants once the testing is over.

      Glucose: 0,15,30,60,120, 180, 240 Insulin: 0, 30, 120, 180, 240 Oxidative Stress Markers: 0,
      180, 240

      The blood insulin level will be determined in venous blood by RIA. Capillary blood glucose
      will be determined with a glucometer. Oxidative stress, e.g., total antioxidant capacity,
      IL-6, and TBARS will be assessed using microplate analyses kits.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: randomized, controlled, crossover
primary purpose: Other
masking: None (Open Label)
measure: Postprandial glycemia
time frame: 4 hours
description: incremental area under curve
measure: postprandial insulinemia
time frame: 4 hours
description: incremental area under curve
measure: postprandial oxidative stress
time frame: 4 hours
description: total antioxidant capacity of blood
measure: postprandial oxidative stress
time frame: 4 hours
description: blood interleukin-6
measure: postprandial oxidative stress
time frame: 4 hours
description: Thiobarbituric Acid Reactive Substances TBARS
arm group label: Control
arm group type: Placebo Comparator
description: Test meal [bagel with butter (20 g) and apple juice (240 ml) with added sugar (24 g)] The meal was a total of 640 kcal (100 g carbohydrate, 21 g fat, 10 g protein. Participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption. One week later the test meal was consumed with fiber (36 g, Metamucil powder, Procter&Gamble, Cincinnati, OH) added to the apple juice (active) and participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption . One week later participants were given 5 minutes to transition to the treadmill following consumption of the test meal and began walking on a motorized treadmill at their calculated preferred walking speed for 15 minutes (experimental). Afterwards participants remained seated in the laboratory with minimal activity for the remainder of the four hours following test meal consumption
arm group label: Fiber
arm group type: Active Comparator
description: Test meal [bagel with butter (20 g) and apple juice (240 ml) with added sugar (24 g)] The meal was a total of 640 kcal (100 g carbohydrate, 21 g fat, 10 g protein. 9 grams of soluble viscous fiber from psyllium husk (36 g, Metamucil powder, Procter&Gamble, Cincinnati, OH) was mixed with the apple juice. Participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption. One week later participants were given 5 minutes to transition to the treadmill following consumption of the test meal and began walking on a motorized treadmill at their calculated preferred walking speed for 15 minutes (experimental). Afterwards participants remained seated in the laboratory with minimal activity for the remainder of the four hours following test meal consumption. One week later the test meal was consumed, and participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption (placebo).
arm group label: Walk
arm group type: Experimental
description: Test meal [bagel with butter (20 g) and apple juice (240 ml) with added sugar (24 g)] The meal was a total of 640 kcal (100 g carbohydrate, 21 g fat, 10 g protein. Participants were given 5 minutes to transition to the treadmill following consumption of the test meal and began walking on a motorized treadmill at their calculated preferred walking speed for 15 minutes. Afterwards participants remained seated in the laboratory with minimal activity for the remainder of the four hours following test meal consumption One week later the test meal was consumed, and participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption (placebo comparator). One week later the test meal was consumed with fiber (36 g, Metamucil powder, Procter&Gamble, Cincinnati, OH) added to the apple juice and participants remained seated in the laboratory with minimal activity for the four hours following test meal consumption (active comparator).
intervention type: Other
intervention name: 15-minute walk at preferred walking speed.
arm group label: Control
arm group label: Fiber
arm group label: Walk
intervention type: Dietary Supplement
intervention name: Fiber
description: 9 grams soluble fiber
arm group label: Control
arm group label: Fiber
arm group label: Walk
intervention type: Other
intervention name: control
description: control
arm group label: Control
arm group label: Fiber
arm group label: Walk
criteria: 
gender: All
minimum age: 35 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Arizona State University
investigator full name: Carol Johnston
investigator title: Professor and Associate Dean
mesh term: Hyperglycemia
mesh term: Prediabetic State
mesh term: Glucose Intolerance
sharing ipd: No