<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/NCT03785470</url>
  </required_header>
  <id_info>
    <org_study_id>2012869</org_study_id>
    <nct_id>NCT03785470</nct_id>
  </id_info>
  <brief_title>Vascular and Metabolic Consequences of Adopting a Westernized Lifestyle</brief_title>
  <official_title>Vascular and Metabolic Consequences of Adopting a Westernized Lifestyle</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Missouri-Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Missouri-Columbia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if short-term adoption of a Westernized lifestyle&#xD;
      characterized by physical inactivity and increased consumption of fructose will result in&#xD;
      metabolic and vascular dysfunction. Healthy individuals aged 18-45 years old will undergo an&#xD;
      acute period of physical inactivity (10 days) coupled with increased fructose consumption.&#xD;
      Augmented fructose consumption will be achieved via commercially available soda beverages&#xD;
      which are high in fructose. Vascular and metabolic function measures will be performed before&#xD;
      and after the 10-day intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Men and women who regularly engage in &gt;10,000 steps per day, age 18-45 years, body mass index&#xD;
      &lt; 30 kg/m2, and with no history of chronic disease will be recruited. Subjects who are&#xD;
      eligible will undergo an acute period of physical inactivity (10 days) coupled with increased&#xD;
      fructose consumption (6 cans/day). Physical activity levels will be assessed via a pedometer&#xD;
      to quantify if individuals achieve &lt;5000 steps/day. Vascular and metabolic function measures&#xD;
      will be performed before and after the 10-day intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2018</start_date>
  <completion_date type="Actual">August 16, 2022</completion_date>
  <primary_completion_date type="Actual">August 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Insulin-stimulated leg blood flow</measure>
    <time_frame>this will be assessed at baseline and at the final visit (10 days)</time_frame>
    <description>Subjects will be instrumented with EKG for contrast-enhanced ultrasound (CEU) measurements. We will perform a hyperinsulinemic euglycemic clamp to evaluate microvascular perfusion of skeletal muscle via CEU. Insulin will be infused at a constant rate to mimic postprandial insulin concentrations and glucose maintained at fasting values via a variable 20% dextrose infusion. At baseline and in the steady state phase of the insulin clamp, we will assess microvascular perfusion in the vastus lateralis muscle using CEU (IE-33, Philips Ultrasound), via infusion of perflutren lipid microspheres. Microvascular perfusion will be assessed as an A-value. A is the video intensity plateau after complete replenishment reflecting relative microvascular blood volume (MBV).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Brachial artery flow mediated dilation (FMD)</measure>
    <time_frame>this will be assessed at baseline and at the final visit (10 days)</time_frame>
    <description>Brachial artery FMD will be assessed at baseline and at 10 days. FMD is a measurement of conduit artery endothelial function. FMD is assessed immediately after each PWV measurement. Shear rate AUC until peak diameter is calculated as stimulus for FMD and used in covariate analysis. All measurements will be performed by the same technician.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in carotid femoral pulse wave velocity (cfPWV)</measure>
    <time_frame>this will be assessed at baseline and at the final visit (10 days)</time_frame>
    <description>It is the gold standard non-invasive index of arterial stiffness. Transit time between carotid and femoral pressure waves is calculated using the foot-to-foot method. cfPWV is calculated as distance traveled by the pulse wave (i.e., femoral location-sternal notch minus sternal notch-carotid location) divided by pulse transit time. All the measurements will be done by the same technician</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Vascular Diseases</condition>
  <arm_group>
    <arm_group_label>Fructose and physical inactivity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will consume 6 cans of soda per day and restrict their physical activity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fructose and physical inactivity</intervention_name>
    <description>Subjects will drink 6 cans of regular sodas daily (divided throughout the day) and will decreased physical activity to less than 5000 steps daily for 10 days.</description>
    <arm_group_label>Fructose and physical inactivity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women who regularly engage in &gt;10,000 steps per day&#xD;
&#xD;
          -  Age 18-45 years&#xD;
&#xD;
          -  Body mass index &lt; 30 kg/m2&#xD;
&#xD;
          -  No history of chronic disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known cardiovascular disease including hypertension, heart failure, coronary artery&#xD;
             disease, and stroke&#xD;
&#xD;
          -  Renal or hepatic diseases&#xD;
&#xD;
          -  Active cancer&#xD;
&#xD;
          -  Autoimmune diseases&#xD;
&#xD;
          -  Current use of immunosuppressant therapy&#xD;
&#xD;
          -  Excessive alcohol consumption (&gt; 14 drinks/week for men and &gt;7 drinks/week for women)&#xD;
&#xD;
          -  Current tobacco use&#xD;
&#xD;
          -  Current pregnancy&#xD;
&#xD;
          -  Diagnosis of type 2 diabetes&#xD;
&#xD;
          -  Regular consumption of &gt;2 non-diet sodas/day&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Camila Manrique Acevedo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Missouri-Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Missouri</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>August 16, 2022</last_update_submitted>
  <last_update_submitted_qc>August 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Missouri-Columbia</investigator_affiliation>
    <investigator_full_name>Camila Manrique</investigator_full_name>
    <investigator_title>Associate Professor, Endocrinology</investigator_title>
  </responsible_party>
  <keyword>arterial stiffness</keyword>
  <keyword>endothelial dysfunction</keyword>
  <keyword>fructose</keyword>
  <keyword>physical inactivity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vascular Diseases</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/NCT03785470
org study id: 2012869
nct id: NCT03785470
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
The purpose of this study is to determine if short-term adoption of a Westernized lifestyle
      characterized by physical inactivity and increased consumption of fructose will result in
      metabolic and vascular dysfunction. Healthy individuals aged 18-45 years old will undergo an
      acute period of physical inactivity (10 days) coupled with increased fructose consumption.
      Augmented fructose consumption will be achieved via commercially available soda beverages
      which are high in fructose. Vascular and metabolic function measures will be performed before
      and after the 10-day intervention.
Men and women who regularly engage in >10,000 steps per day, age 18-45 years, body mass index
      < 30 kg/m2, and with no history of chronic disease will be recruited. Subjects who are
      eligible will undergo an acute period of physical inactivity (10 days) coupled with increased
      fructose consumption (6 cans/day). Physical activity levels will be assessed via a pedometer
      to quantify if individuals achieve <5000 steps/day. Vascular and metabolic function measures
      will be performed before and after the 10-day intervention.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in Insulin-stimulated leg blood flow
time frame: this will be assessed at baseline and at the final visit (10 days)
description: Subjects will be instrumented with EKG for contrast-enhanced ultrasound (CEU) measurements. We will perform a hyperinsulinemic euglycemic clamp to evaluate microvascular perfusion of skeletal muscle via CEU. Insulin will be infused at a constant rate to mimic postprandial insulin concentrations and glucose maintained at fasting values via a variable 20% dextrose infusion. At baseline and in the steady state phase of the insulin clamp, we will assess microvascular perfusion in the vastus lateralis muscle using CEU (IE-33, Philips Ultrasound), via infusion of perflutren lipid microspheres. Microvascular perfusion will be assessed as an A-value. A is the video intensity plateau after complete replenishment reflecting relative microvascular blood volume (MBV).
measure: Change in Brachial artery flow mediated dilation (FMD)
time frame: this will be assessed at baseline and at the final visit (10 days)
description: Brachial artery FMD will be assessed at baseline and at 10 days. FMD is a measurement of conduit artery endothelial function. FMD is assessed immediately after each PWV measurement. Shear rate AUC until peak diameter is calculated as stimulus for FMD and used in covariate analysis. All measurements will be performed by the same technician.
measure: Change in carotid femoral pulse wave velocity (cfPWV)
time frame: this will be assessed at baseline and at the final visit (10 days)
description: It is the gold standard non-invasive index of arterial stiffness. Transit time between carotid and femoral pressure waves is calculated using the foot-to-foot method. cfPWV is calculated as distance traveled by the pulse wave (i.e., femoral location-sternal notch minus sternal notch-carotid location) divided by pulse transit time. All the measurements will be done by the same technician
arm group label: Fructose and physical inactivity
arm group type: Experimental
description: Subjects will consume 6 cans of soda per day and restrict their physical activity.
intervention type: Other
intervention name: Fructose and physical inactivity
description: Subjects will drink 6 cans of regular sodas daily (divided throughout the day) and will decreased physical activity to less than 5000 steps daily for 10 days.
arm group label: Fructose and physical inactivity
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Camila Manrique Acevedo, MD
role: Principal Investigator
affiliation: University of Missouri-Columbia
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Missouri-Columbia
investigator full name: Camila Manrique
investigator title: Associate Professor, Endocrinology
mesh term: Vascular Diseases
sharing ipd: No