<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/NCT02185729</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00007543</org_study_id>
    <nct_id>NCT02185729</nct_id>
  </id_info>
  <brief_title>Comparing Soybean Oil-Based (Intralipid) With an Olive Oil-Based (ClinOleic) Lipid Emulsion on Healthy Volunteers</brief_title>
  <acronym>TPN1</acronym>
  <official_title>Randomized Study Comparing Soybean Oil-Based (Intralipid) With an Olive Oil-Based (ClinOleic) Lipid Emulsion: Effects on Endothelial Function, Inflammatory Markers, Oxidative Stress, Immune Function, Autonomic Nervous System, Insulin Sensitivity and Carbohydrate Metabolism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Baxter Healthcare Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Many patients in the hospital who are malnourished or not eating received intravenous feeding&#xD;
      or total parenteral nutrition (TPN). Despite improving nutrition, TPN may increase the risk&#xD;
      of infections and hospital complications. We do not know why TPN increases hospital&#xD;
      complications, but it may be caused by the high sugar or fat content in TPN solutions. The&#xD;
      investigators believe that the high sugar and high fat content can limit the ability to fight&#xD;
      infections and produce stiffness of blood vessels. This study will compare the effect of high&#xD;
      sugar, high fat content or both on blood sugars, blood vessel function, on blood vessel&#xD;
      function. The investigators will also compare the effect of different fats (olive oil and&#xD;
      soybean) in the TPN solution on the risk of infection and blood vessel function on a total of&#xD;
      12 healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2008</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">March 2012</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Flow Mediated Dilation</measure>
    <time_frame>Baseline</time_frame>
    <description>Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter - baseline diameter)/baseline diameter × 100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Flow Mediated Dilation</measure>
    <time_frame>4 hours after infusion</time_frame>
    <description>Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter - 4 hour diameter)/4 hour diameter × 100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Flow Mediated Dilation</measure>
    <time_frame>24 hours after infusion</time_frame>
    <description>Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter - 24 hour diameter)/24 hour diameter × 100.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Diseases, Metabolic</condition>
  <condition>Insulin Sensitivity</condition>
  <arm_group>
    <arm_group_label>Healthy Volunteer</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects receive 24 hours of infusion of 0.9% normal saline, dextrose (sugar) without fat, ClinOleic (olive oil-based), and Intralipid (soybean-derived fat)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intralipid</intervention_name>
    <description>Infusion of Intralipid (soybean-derived fat)</description>
    <arm_group_label>Healthy Volunteer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ClinOleic</intervention_name>
    <description>Infusion of ClinOleic (olive oil-based)</description>
    <arm_group_label>Healthy Volunteer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dextrose</intervention_name>
    <description>Infusion of dextrose (sugar) without fat</description>
    <arm_group_label>Healthy Volunteer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Saline (control)</intervention_name>
    <description>Infusion of 0.9% normal saline</description>
    <arm_group_label>Healthy Volunteer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males or females, BMI 25 - 35 kg/m2, between the ages of 18 and 65 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient is pregnant or breast feeding&#xD;
&#xD;
          -  Subjects have or with history of diabetes, hypertension, fasting triglyceride levels &gt;&#xD;
             250 mg/dL, liver disease (ALT 2.5x &gt; upper limit of normal), serum creatinine ≥1.5&#xD;
             mg/dL&#xD;
&#xD;
          -  Smokers or ex-smoker &lt; 3 months of cessation, drug or alcohol abuse&#xD;
&#xD;
          -  Mental condition rendering the subject unable to understand the scope and possible&#xD;
             consequences of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guillermo Umpierrez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Grady Memorial Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Siqueira J, Smiley D, Newton C, Le NA, Gosmanov AR, Spiegelman R, Peng L, Osteen SJ, Jones DP, Quyyumi AA, Ziegler TR, Umpierrez GE. Substitution of standard soybean oil with olive oil-based lipid emulsion in parenteral nutrition: comparison of vascular, metabolic, and inflammatory effects. J Clin Endocrinol Metab. 2011 Oct;96(10):3207-16. doi: 10.1210/jc.2011-0480. Epub 2011 Aug 10.</citation>
    <PMID>21832112</PMID>
  </results_reference>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <results_first_submitted>December 18, 2014</results_first_submitted>
  <results_first_submitted_qc>December 18, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 31, 2014</results_first_posted>
  <last_update_submitted>December 18, 2014</last_update_submitted>
  <last_update_submitted_qc>December 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 31, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Guillermo Umpierrez</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Intravenous Feeding</keyword>
  <keyword>Lipid Emulsions, Intravenous</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Metabolic Diseases</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Soybean oil, phospholipid emulsion</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>All subjects seen at Grady Memorial Hospital Clinical Interactions Network unit of the Atlanta Clinical and Translational Science Institute. Subjects were admitted on the afternoon before the study protocol began.</recruitment_details>
      <pre_assignment_details>An overnight fast, subjects underwent research studies in the morning with the infusion starting between 1200 and 1300 h.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Healthy Volunteer</title>
          <description>Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat), ClinOleic (olive oil), dextrose (sugar) without fat, and a 24-hour infusion of normal saline (control)&#xD;
Intralipid&#xD;
ClinOleic&#xD;
Dextrose&#xD;
Saline (control)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>0 Hour (Baseline) of Saline Infusion</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>4 Hours Into Saline Infusion</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>24 Hours Into Saline Infusion</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>0 Hour (Baseline) of Intralipid Infusion</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>4 Hours Into Intralipid Infusion</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>24 Hours Into Intralipid Infusion</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>0 Hour (Baseline) of ClinOleic Infusion</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>4 Hours Into ClinOleic Infusion</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>24 Hours Into ClinOleic Infusion</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>0 Hour (Baseline) of Dextrose Infusion</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>4 Hours Into Dextrose Infusion</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>24 Hours Into Dextrose Infusion</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Healthy Volunteer</title>
          <description>Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat), ClinOleic (olive oil), dextrose (sugar) without fat, and a 24-hour infusion of normal saline (control)&#xD;
Intralipid&#xD;
ClinOleic&#xD;
Dextrose&#xD;
Saline (control)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Flow Mediated Dilation</title>
        <description>Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter - baseline diameter)/baseline diameter × 100.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intralipid</title>
            <description>Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat)</description>
          </group>
          <group group_id="O2">
            <title>ClinOleic</title>
            <description>Healthy subjects receive 24-hour TPN infusion of ClinOleic (olive oil)</description>
          </group>
          <group group_id="O3">
            <title>Dextrose</title>
            <description>Healthy subjects receive 24-hour TPN infusion of dextrose (sugar) without fat</description>
          </group>
          <group group_id="O4">
            <title>Saline</title>
            <description>Healthy subjects receive 24-hour infusion of normal saline (control)</description>
          </group>
        </group_list>
        <measure>
          <title>Flow Mediated Dilation</title>
          <description>Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter - baseline diameter)/baseline diameter × 100.</description>
          <units>percentage of brachial artery diameter</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.3" spread="0.88"/>
                    <measurement group_id="O2" value="8.9" spread="0.80"/>
                    <measurement group_id="O3" value="9.2" spread="0.72"/>
                    <measurement group_id="O4" value="9.1" spread="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Flow Mediated Dilation</title>
        <description>Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter - 4 hour diameter)/4 hour diameter × 100.</description>
        <time_frame>4 hours after infusion</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intralipid</title>
            <description>Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat)</description>
          </group>
          <group group_id="O2">
            <title>ClinOleic</title>
            <description>Healthy subjects receive 24-hour TPN infusion of ClinOleic (olive oil)</description>
          </group>
          <group group_id="O3">
            <title>Dextrose</title>
            <description>Healthy subjects receive 24-hour TPN infusion of dextrose (sugar) without fat</description>
          </group>
          <group group_id="O4">
            <title>Saline</title>
            <description>Healthy subjects receive 24-hour infusion of normal saline (control)</description>
          </group>
        </group_list>
        <measure>
          <title>Flow Mediated Dilation</title>
          <description>Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter - 4 hour diameter)/4 hour diameter × 100.</description>
          <units>percentage of brachial artery diameter</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9" spread="0.83"/>
                    <measurement group_id="O2" value="9.0" spread="0.88"/>
                    <measurement group_id="O3" value="8.3" spread="0.67"/>
                    <measurement group_id="O4" value="8.2" spread="1.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Flow Mediated Dilation</title>
        <description>Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter - 24 hour diameter)/24 hour diameter × 100.</description>
        <time_frame>24 hours after infusion</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intralipid</title>
            <description>Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat)</description>
          </group>
          <group group_id="O2">
            <title>ClinOleic</title>
            <description>Healthy subjects receive 24-hour TPN infusion of ClinOleic (olive oil)</description>
          </group>
          <group group_id="O3">
            <title>Dextrose</title>
            <description>Healthy subjects receive 24-hour TPN infusion of dextrose (sugar) without fat</description>
          </group>
          <group group_id="O4">
            <title>Saline</title>
            <description>Healthy subjects receive 24-hour infusion of normal saline (control)</description>
          </group>
        </group_list>
        <measure>
          <title>Flow Mediated Dilation</title>
          <description>Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter - 24 hour diameter)/24 hour diameter × 100.</description>
          <units>percentage of brachial artery diameter</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2" spread="0.74"/>
                    <measurement group_id="O2" value="9.1" spread="0.91"/>
                    <measurement group_id="O3" value="10.2" spread="1.15"/>
                    <measurement group_id="O4" value="9.7" spread="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Healthy Volunteer</title>
          <description>Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat), ClinOleic (olive oil), dextrose (sugar) without fat, and a 24-hour infusion of normal saline (control)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Short duration and involved healthy volunteers--not clear whether the use of olive oil-based lipid emulsions may result in improved clinical outcomes over traditional lipid emulsions in hospitalized patients with medical and surgical illness.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Guillermo Umpierrez</name_or_title>
      <organization>Emory University</organization>
      <phone>404-778-1665</phone>
      <email>geumpie@emory.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02185729
org study id: IRB00007543
nct id: NCT02185729
lead sponsor: 
collaborator: 
has dmc: Yes
Many patients in the hospital who are malnourished or not eating received intravenous feeding
      or total parenteral nutrition (TPN). Despite improving nutrition, TPN may increase the risk
      of infections and hospital complications. We do not know why TPN increases hospital
      complications, but it may be caused by the high sugar or fat content in TPN solutions. The
      investigators believe that the high sugar and high fat content can limit the ability to fight
      infections and produce stiffness of blood vessels. This study will compare the effect of high
      sugar, high fat content or both on blood sugars, blood vessel function, on blood vessel
      function. The investigators will also compare the effect of different fats (olive oil and
      soybean) in the TPN solution on the risk of infection and blood vessel function on a total of
      12 healthy subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Flow Mediated Dilation
time frame: Baseline
description: Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter - baseline diameter)/baseline diameter × 100.
measure: Flow Mediated Dilation
time frame: 4 hours after infusion
description: Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter - 4 hour diameter)/4 hour diameter × 100.
measure: Flow Mediated Dilation
time frame: 24 hours after infusion
description: Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter - 24 hour diameter)/24 hour diameter × 100.
arm group label: Healthy Volunteer
arm group type: Active Comparator
description: Subjects receive 24 hours of infusion of 0.9% normal saline, dextrose (sugar) without fat, ClinOleic (olive oil-based), and Intralipid (soybean-derived fat)
intervention type: Drug
intervention name: Intralipid
description: Infusion of Intralipid (soybean-derived fat)
arm group label: Healthy Volunteer
intervention type: Drug
intervention name: ClinOleic
description: Infusion of ClinOleic (olive oil-based)
arm group label: Healthy Volunteer
intervention type: Drug
intervention name: Dextrose
description: Infusion of dextrose (sugar) without fat
arm group label: Healthy Volunteer
intervention type: Other
intervention name: Saline (control)
description: Infusion of 0.9% normal saline
arm group label: Healthy Volunteer
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Guillermo Umpierrez, MD
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
citation: Siqueira J, Smiley D, Newton C, Le NA, Gosmanov AR, Spiegelman R, Peng L, Osteen SJ, Jones DP, Quyyumi AA, Ziegler TR, Umpierrez GE. Substitution of standard soybean oil with olive oil-based lipid emulsion in parenteral nutrition: comparison of vascular, metabolic, and inflammatory effects. J Clin Endocrinol Metab. 2011 Oct;96(10):3207-16. doi: 10.1210/jc.2011-0480. Epub 2011 Aug 10.
PMID: 21832112
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Guillermo Umpierrez
investigator title: Professor
mesh term: Insulin Resistance
mesh term: Metabolic Diseases
mesh term: Hypersensitivity
mesh term: Soybean oil, phospholipid emulsion
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Short duration and involved healthy volunteers--not clear whether the use of olive oil-based lipid emulsions may result in improved clinical outcomes over traditional lipid emulsions in hospitalized patients with medical and surgical illness.
point of contact: 