<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/NCT01705782</url>
  </required_header>
  <id_info>
    <org_study_id>2012-410-12</org_study_id>
    <nct_id>NCT01705782</nct_id>
  </id_info>
  <brief_title>The Effects of Amino Acid Supplement During Acute Inflammation.</brief_title>
  <official_title>Metabolic Effects of Endotoxin Induced Acute Inflammation in Healthy Young Men With and Without Supplement of Amino Acids.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to investigate the metabolic effects during acute inflammation&#xD;
      with and without the nutritional supplement of amino acids.&#xD;
&#xD;
      E. Coli Endotoxin (LPS, lipopolysaccharide) is used to initiate an inflammatory response.&#xD;
&#xD;
      The study is an interventional randomized placebo study including 8 healthy male subjects.&#xD;
      Each subject participates 3 times (different days) and are given one of following&#xD;
      interventions:&#xD;
&#xD;
        -  Placebo (NaCl)&#xD;
&#xD;
        -  Endotoxin, US standard reference E.Coli + Placebo (NaCl)&#xD;
&#xD;
        -  Endotoxin, US standard reference E.Coli + Amino acids (intravenously)&#xD;
&#xD;
      It is our hypothesis that the nutritional intervention during acute inflammation plays an&#xD;
      important role in lipid and protein metabolism.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Protein catabolism during acute illness</measure>
    <time_frame>After 6 hours intervention</time_frame>
    <description>Protein catabolism is measured with amino acid tracer techniques comparing radioactive marked amino acids from blood samples.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The local effects on muscle and fat tissue</measure>
    <time_frame>At 2 hours and 4,5 hours</time_frame>
    <description>A muscle + fat biopsy are taken twice during the intervention to focus on the local effects in these tissues.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other systemic metabolic effects during acute illness</measure>
    <time_frame>6 hours</time_frame>
    <description>Lipid and glucose metabolism are measured with tracer techniques with radioactive marked glucose + lipid.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Febrile Illness Acute</condition>
  <condition>Inflammation</condition>
  <condition>Metabolic Diseases</condition>
  <arm_group>
    <arm_group_label>Saline</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Only saline is given.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>+ Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Endotoxin is given + Placebo (Saline)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>+ amino acids</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Endotoxin is given + amino acids (intravenously)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>E. coli endotoxin, US standard</intervention_name>
    <arm_group_label>+ Saline</arm_group_label>
    <arm_group_label>+ amino acids</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male gender&#xD;
&#xD;
          -  20&lt;BMI&lt;30&#xD;
&#xD;
          -  Age &gt; 25 years old&#xD;
&#xD;
          -  Written consent before starting the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy for soya products ore egg&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Infection&#xD;
&#xD;
          -  Immune defects&#xD;
&#xD;
          -  Heart disease&#xD;
&#xD;
          -  Dysregulated hypertension&#xD;
&#xD;
          -  Participating in other trials using radioactive tracers or x-rays the last year.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical Department MEA, NBG, Aarhus University Hospital</name>
      <address>
        <city>Aarhus C</city>
        <state>Jylland</state>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>November 11, 2014</last_update_submitted>
  <last_update_submitted_qc>November 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Aarhus</investigator_affiliation>
    <investigator_full_name>Nikolaj Fibiger Rittig</investigator_full_name>
    <investigator_title>MD (medical graduate) and Ph.d.-student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Diseases</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01705782
org study id: 2012-410-12
nct id: NCT01705782
lead sponsor: 
has dmc: Yes
The purpose of the study is to investigate the metabolic effects during acute inflammation
      with and without the nutritional supplement of amino acids.

      E. Coli Endotoxin (LPS, lipopolysaccharide) is used to initiate an inflammatory response.

      The study is an interventional randomized placebo study including 8 healthy male subjects.
      Each subject participates 3 times (different days) and are given one of following
      interventions:

        -  Placebo (NaCl)

        -  Endotoxin, US standard reference E.Coli + Placebo (NaCl)

        -  Endotoxin, US standard reference E.Coli + Amino acids (intravenously)

      It is our hypothesis that the nutritional intervention during acute inflammation plays an
      important role in lipid and protein metabolism.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Protein catabolism during acute illness
time frame: After 6 hours intervention
description: Protein catabolism is measured with amino acid tracer techniques comparing radioactive marked amino acids from blood samples.
measure: The local effects on muscle and fat tissue
time frame: At 2 hours and 4,5 hours
description: A muscle + fat biopsy are taken twice during the intervention to focus on the local effects in these tissues.
measure: Other systemic metabolic effects during acute illness
time frame: 6 hours
description: Lipid and glucose metabolism are measured with tracer techniques with radioactive marked glucose + lipid.
arm group label: Saline
arm group type: No Intervention
description: Only saline is given.
arm group label: + Saline
arm group type: Placebo Comparator
description: Endotoxin is given + Placebo (Saline)
arm group label: + amino acids
arm group type: Active Comparator
description: Endotoxin is given + amino acids (intravenously)
intervention type: Biological
intervention name: E. coli endotoxin, US standard
arm group label: + Saline
arm group label: + amino acids
criteria: 
gender: Male
minimum age: 25 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Aarhus
investigator full name: Nikolaj Fibiger Rittig
investigator title: MD (medical graduate) and Ph.d.-student
mesh term: Metabolic Diseases
mesh term: Inflammation