<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/NCT02241681</url>
  </required_header>
  <id_info>
    <org_study_id>14.22.MET</org_study_id>
    <nct_id>NCT02241681</nct_id>
  </id_info>
  <brief_title>Medium Chain Triglycerides Plasma Profile and Their Metabolites After Oral Peptamen Intake</brief_title>
  <official_title>Medium Chain Triglycerides Plasma Profile and Their Metabolites After Oral Peptamen Intake</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Société des Produits Nestlé (SPN)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Société des Produits Nestlé (SPN)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Medium Chain Triglycerides (MCT) have been used for many years as a good source of lipid to&#xD;
      decrease potential for fat malabsorption. However, the pharmacokinetics of MCT and of their&#xD;
      metabolites have not been explored in details.&#xD;
&#xD;
      This is an exploratory study aiming at determining the plasma level of MCT and their&#xD;
      metabolites after oral intake of Peptamen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      20 subjects will be given 250mL of peptamen 1.5 twice, with 4 hours of interval, on a single&#xD;
      day.&#xD;
&#xD;
      Plasma kinetics of MCTs and their metabolites will be made over 8 hours from baseline&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measure of plasma Medium Chain Triglycerides (MCT)</measure>
    <time_frame>over 8 hours post intake</time_frame>
    <description>Tmax, Cmax and AUC for MCTs as compared to baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure of plasma MCT metabolites such as free fatty acids</measure>
    <time_frame>over 8 hours post intake</time_frame>
    <description>Tmax, Cmax and AUC for MCT metabolites as compared to baseline</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Peptamen 1.5</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>500 mL of Peptamen 1.5</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Peptamen 1.5</intervention_name>
    <description>Peptamen will be given twice at the dose of 250 mL, with an interval of 4 hours.</description>
    <arm_group_label>Peptamen 1.5</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males and females&#xD;
&#xD;
          -  Aged between 20 and 65 years old&#xD;
&#xD;
          -  BMI in the normal range (18.5 to 25.0 kg/m2)&#xD;
&#xD;
          -  Having signed his/her consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically relevant digestive (including malabsorption or major surgery), renal,&#xD;
             hepatic, pancreatic or metabolic disease (diabetes, hypo or hyperthyroidism, hypo or&#xD;
             hypercorticism), as determined by the medical (screening) visit and a standard blood&#xD;
             chemistry analysis (glucose, total cholesterol, ALDL, AHDL, triglycerides, ASAT, ALTI,&#xD;
             gamma GT, RCRP, creatinine)&#xD;
&#xD;
          -  Medically diagnosed anemia based on a blood formula&#xD;
&#xD;
          -  Food allergy, lactose intolerance and intolerance to milk proteins (anamnesis)&#xD;
&#xD;
          -  Smokers (anamnesis)&#xD;
&#xD;
          -  Pregnancy (anamnesis)&#xD;
&#xD;
          -  Under corticoids or hormone (adrenal, thyroid) treatment&#xD;
&#xD;
          -  Alcohol intake: &gt; 2 units a day (anamnesis)&#xD;
&#xD;
          -  Consumption of illicit drugs (anamnesis)&#xD;
&#xD;
          -  Having given blood within the last month, or willing to make a blood donation until&#xD;
             one month following the end of the study&#xD;
&#xD;
          -  Subject who cannot be expected to comply with the study procedures, including&#xD;
             consuming the test product&#xD;
&#xD;
          -  Currently participating or having participated in another clinical trial during the&#xD;
             last month prior to the beginning of this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maurice Beaumont, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Metabolic Unit, Clinical Development Unit,Nestec</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Metabolic unit, clinical Development unit, Nestec</name>
      <address>
        <city>Lausanne</city>
        <zip>1000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>March 25, 2015</last_update_submitted>
  <last_update_submitted_qc>March 25, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 26, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Medium Chain Triglycerides</keyword>
  <keyword>Medium Chain Triglycerides metabolites</keyword>
  <keyword>Peptamen 1.5</keyword>
  <!-- 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/NCT02241681
org study id: 14.22.MET
nct id: NCT02241681
lead sponsor: 
has dmc: No
Medium Chain Triglycerides (MCT) have been used for many years as a good source of lipid to
      decrease potential for fat malabsorption. However, the pharmacokinetics of MCT and of their
      metabolites have not been explored in details.

      This is an exploratory study aiming at determining the plasma level of MCT and their
      metabolites after oral intake of Peptamen.
20 subjects will be given 250mL of peptamen 1.5 twice, with 4 hours of interval, on a single
      day.

      Plasma kinetics of MCTs and their metabolites will be made over 8 hours from baseline
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Measure of plasma Medium Chain Triglycerides (MCT)
time frame: over 8 hours post intake
description: Tmax, Cmax and AUC for MCTs as compared to baseline.
measure: Measure of plasma MCT metabolites such as free fatty acids
time frame: over 8 hours post intake
description: Tmax, Cmax and AUC for MCT metabolites as compared to baseline
arm group label: Peptamen 1.5
arm group type: Other
description: 500 mL of Peptamen 1.5
intervention type: Dietary Supplement
intervention name: Peptamen 1.5
description: Peptamen will be given twice at the dose of 250 mL, with an interval of 4 hours.
arm group label: Peptamen 1.5
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maurice Beaumont, MD,PhD
role: Principal Investigator
affiliation: Metabolic Unit, Clinical Development Unit,Nestec
facility: 
country: Switzerland
responsible party type: Sponsor