<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/NCT01727583</url>
  </required_header>
  <id_info>
    <org_study_id>12.10.MET</org_study_id>
    <nct_id>NCT01727583</nct_id>
  </id_info>
  <brief_title>Boosting the Secretion of GLP-2 and GLP-1 Intestinal Hormones by Nutrients</brief_title>
  <official_title>Boosting the Secretion of GLP-2 and GLP-1 Intestinal Hormones by Nutrients</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>
      This pilot study is aimed at assessing the acute effect of several combinations of lipids&#xD;
      differing in their fatty acid composition on glucagon-like-peptide (GLP)-2 and GLP-1&#xD;
      secretion in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, the investigators aim to investigate the effect of various lipid types on&#xD;
      GLP-2 and GLP-1 secretion. This will allow to determine the importance of lipids in&#xD;
      nutritional solutions. Moreover, this will allow us to assess whether existing clinical&#xD;
      formulas can be improved in order to stimulate GLP-2 and accelerate intestinal recovery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">October 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>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>GLP-2 and GLP-1 kinetics</measure>
    <time_frame>changes from baseline to 4 hours following meal intake</time_frame>
    <description>GLP-2 and GLP-1 are measured using Elisa</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intestinal and metabolic hormones</measure>
    <time_frame>Changes from baseline to 4 hours following meal intake</time_frame>
    <description>Those hormones will be measured based on enzymatic technics</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Lipid 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Meal intake</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lipid-free</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Maltodextrine + proteins</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lipid 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Meal intake</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lipid 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Meal intake</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lipid 4</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>meal intake</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>meal intake</intervention_name>
    <description>Intake of meals characterized by lipid composition</description>
    <arm_group_label>Lipid 1</arm_group_label>
    <arm_group_label>Lipid 2</arm_group_label>
    <arm_group_label>Lipid 3</arm_group_label>
    <arm_group_label>Lipid 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Lipid-free</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI : 19 - 24.9 kg.m-2&#xD;
&#xD;
          -  Normal fasting glycemia&#xD;
&#xD;
          -  Having obtained his informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gastro-intestinal disease (ulcer), pancreatic disease, hepatic disease, metabolic&#xD;
             diseases / disorders (diabetes, dyslipidemia), renal disease, cardiovascular disease&#xD;
             (arterial hypertension), as determined by the medical screening visit and a blood&#xD;
             analysis.&#xD;
&#xD;
          -  Have had a gastrointestinal surgery (with the exception of appendices resection).&#xD;
&#xD;
          -  Malabsorption disorders&#xD;
&#xD;
          -  Lactose intolerance&#xD;
&#xD;
          -  Significant weight loss during the past three months (more than 5% of initial weight)&#xD;
&#xD;
          -  Have a regular consumption of medication&#xD;
&#xD;
          -  Regular supplements (vitamins and minerals) intake during the previous month&#xD;
&#xD;
          -  Have an alcohol intake: &gt; 2 units a day&#xD;
&#xD;
          -  Smoker (more than 2 cigarettes a day)&#xD;
&#xD;
          -  Illicit substances intake, as stated on the medical screening questionnaire&#xD;
&#xD;
          -  Allergy to any food or medication&#xD;
&#xD;
          -  Anaemia defined by a number of erythrocytes or hemoglobin Hb or hematocrit Ht which&#xD;
             are inferior to laboratory normal ranges&#xD;
&#xD;
          -  Having given blood in the past three months or willing to give blood in the 3 months&#xD;
             following the completion of the study&#xD;
&#xD;
          -  Intense physical activity &gt; 3 hours per week&#xD;
&#xD;
          -  Currently participating or having participated in another clinical trial during the&#xD;
             past month.&#xD;
&#xD;
          -  Volunteer who cannot be expected to comply with the protocol, including consuming&#xD;
             rapidly the study products, chronic medication intake&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maurice Beaumont, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nestlé / CDU / Metabolic Unit</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nestlé CDU / Metabolic Unit</name>
      <address>
        <city>Lausanne</city>
        <zip>1000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>November 7, 2013</last_update_submitted>
  <last_update_submitted_qc>November 7, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 8, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy</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/NCT01727583
org study id: 12.10.MET
nct id: NCT01727583
lead sponsor: 
has dmc: No
This pilot study is aimed at assessing the acute effect of several combinations of lipids
      differing in their fatty acid composition on glucagon-like-peptide (GLP)-2 and GLP-1
      secretion in healthy subjects.
In this study, the investigators aim to investigate the effect of various lipid types on
      GLP-2 and GLP-1 secretion. This will allow to determine the importance of lipids in
      nutritional solutions. Moreover, this will allow us to assess whether existing clinical
      formulas can be improved in order to stimulate GLP-2 and accelerate intestinal recovery.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: GLP-2 and GLP-1 kinetics
time frame: changes from baseline to 4 hours following meal intake
description: GLP-2 and GLP-1 are measured using Elisa
measure: Intestinal and metabolic hormones
time frame: Changes from baseline to 4 hours following meal intake
description: Those hormones will be measured based on enzymatic technics
arm group label: Lipid 1
arm group type: Active Comparator
description: Meal intake
arm group label: Lipid-free
arm group type: Placebo Comparator
description: Maltodextrine + proteins
arm group label: Lipid 2
arm group type: Active Comparator
description: Meal intake
arm group label: Lipid 3
arm group type: Active Comparator
description: Meal intake
arm group label: Lipid 4
arm group type: Active Comparator
description: meal intake
intervention type: Dietary Supplement
intervention name: meal intake
description: Intake of meals characterized by lipid composition
arm group label: Lipid 1
arm group label: Lipid 2
arm group label: Lipid 3
arm group label: Lipid 4
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Lipid-free
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maurice Beaumont, MD
role: Principal Investigator
affiliation: Nestlé / CDU / Metabolic Unit
facility: 
country: Switzerland
responsible party type: Sponsor