<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/NCT01726647</url>
  </required_header>
  <id_info>
    <org_study_id>08.02.NRC</org_study_id>
    <nct_id>NCT01726647</nct_id>
  </id_info>
  <brief_title>Metabolism Associated With Abdominal Fat Mass Distribution</brief_title>
  <official_title>Metabolism Associated With Abdominal Fat Mass Distribution</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Société des Produits Nestlé (SPN)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Lausanne Hospitals</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Société des Produits Nestlé (SPN)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives:&#xD;
&#xD;
      The primary objective of this clinical trial is to characterize metabolic signatures&#xD;
      associated with abdominal fat distribution in 40 women with different BMI 29-40 and different&#xD;
      abdominal distribution of fat (visceral vs. sub-cutaneous fat).&#xD;
&#xD;
      No intervention with a product is planned. The subjects will be given one high fat meal with&#xD;
      commercial products (eggs, milk, cream, bread, fruits, cheese and cheese) on one test day to&#xD;
      test the post-prandial metabolic response.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2008</start_date>
  <completion_date type="Actual">April 2012</completion_date>
  <primary_completion_date type="Actual">October 2009</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Metabolic plasma, urine and faeces profiles as a function of fat mass distribution</measure>
    <time_frame>Changes from baseline in metabolic profiles at one day following fat meal intake</time_frame>
    <description>Metabolic profiles of plasma, urine and feces samples are obtained by Nuclear Magnetic Resonance spectroscopy and Mass Spectrometry.&#xD;
Fat mass distribution is assessed using CT scan and DXA (Dual X-Ray Energy Absorptiometry).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Insulin sensitivity</measure>
    <time_frame>Measured on the day before the fat meal intake</time_frame>
    <description>Insulin sensitivity is measured by oral glucose tolerance test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Basal Energy Expenditure</measure>
    <time_frame>Basal Energy Expenditure is measured on the day preceding the fat meal intake</time_frame>
    <description>Basal Energy Expenditure is measured by indirect calorimetry</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Obese</condition>
  <arm_group>
    <arm_group_label>No product is tested</arm_group_label>
    <description>No intervention</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Obese women&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI 29-40 kg/m2&#xD;
&#xD;
          -  Aged 25-45&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed metabolic disorder such as Diabetes type 1 and 2, cardiovascular disease,&#xD;
             metabolic syndrome&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Any pathology (infectious or other) having required an antibiotic therapy within 1&#xD;
             month prior to the beginning of the study.&#xD;
&#xD;
          -  Any therapy (contraception apart) within the run-in period of one week before the test&#xD;
             day.&#xD;
&#xD;
          -  Subject who cannot be expected to comply with treatments and measures.&#xD;
&#xD;
          -  Subject who is affected by any specific eating disorder&#xD;
&#xD;
          -  Currently participating or having participated in another clinical trial during the&#xD;
             last 3 months prior to the beginning of this study.&#xD;
&#xD;
          -  Subjects having recently undergone a weight loss of more than 3 kilos during the last&#xD;
             3 months&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vittorio Giusti, MD, PD/MER</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals of Lausanne</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nestlé Clinical Development Unit / Metabolic Unit</name>
      <address>
        <city>Lausanne 26</city>
        <zip>1000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals, Service of endocrinology, diabetology, and metabolism</name>
      <address>
        <city>Lausanne</city>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>November 9, 2012</last_update_submitted>
  <last_update_submitted_qc>November 9, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>obese women</keyword>
  <keyword>fat mass distribution</keyword>
  <keyword>Metabolomic profiles</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/NCT01726647
org study id: 08.02.NRC
nct id: NCT01726647
lead sponsor: 
collaborator: 
has dmc: No
Objectives:

      The primary objective of this clinical trial is to characterize metabolic signatures
      associated with abdominal fat distribution in 40 women with different BMI 29-40 and different
      abdominal distribution of fat (visceral vs. sub-cutaneous fat).

      No intervention with a product is planned. The subjects will be given one high fat meal with
      commercial products (eggs, milk, cream, bread, fruits, cheese and cheese) on one test day to
      test the post-prandial metabolic response.
measure: Metabolic plasma, urine and faeces profiles as a function of fat mass distribution
time frame: Changes from baseline in metabolic profiles at one day following fat meal intake
description: Metabolic profiles of plasma, urine and feces samples are obtained by Nuclear Magnetic Resonance spectroscopy and Mass Spectrometry.
Fat mass distribution is assessed using CT scan and DXA (Dual X-Ray Energy Absorptiometry).
measure: Insulin sensitivity
time frame: Measured on the day before the fat meal intake
description: Insulin sensitivity is measured by oral glucose tolerance test
measure: Basal Energy Expenditure
time frame: Basal Energy Expenditure is measured on the day preceding the fat meal intake
description: Basal Energy Expenditure is measured by indirect calorimetry
arm group label: No product is tested
description: No intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Vittorio Giusti, MD, PD/MER
role: Principal Investigator
affiliation: University Hospitals of Lausanne
facility: 
facility: 
country: Switzerland
responsible party type: Sponsor