<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/NCT01685307</url>
  </required_header>
  <id_info>
    <org_study_id>PRONUTRIAL</org_study_id>
    <nct_id>NCT01685307</nct_id>
  </id_info>
  <brief_title>Impact of Cooking Process on Meat Protein Digestion and Metabolism</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Research Agency, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Few is known on meat protein digestibility in humans and the impact of cooking process, while&#xD;
      excessive intake of processed meat has been suggested to increase the risk of colorectal&#xD;
      cancer.&#xD;
&#xD;
      This study aims to measure in vivo in humans the real digestibility of beef meat proteins&#xD;
      depending 2 cooking processes, using ileal tubes and stable isotopes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2012</start_date>
  <primary_completion_date type="Actual">September 2012</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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>protein digestibility</measure>
    <time_frame>single measure</time_frame>
    <description>From ileal recovery of the ingested tracer during 8 h after the meal</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>nitrogen metabolism</measure>
    <time_frame>single measure</time_frame>
    <description>Distribution of dietary nitrogen throug metabolic pools</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Physiology</condition>
  <condition>Digestive Tract</condition>
  <condition>Heating Process</condition>
  <arm_group>
    <arm_group_label>intense cooking process</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test meal: 150g of beef cooked at intense temperature. Beef proteins are intrinsically labelled with 15 N protein</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mild cooking process</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test meal: 150 g of beef cooked at moderate intensity. Beef proteins are intrinsically labeled with 15N.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Test meal</intervention_name>
    <description>test meal is 150 g of beef cooked either at moderate or high intensity. Proteins are intrinsically labelled with 15N.</description>
    <arm_group_label>intense cooking process</arm_group_label>
    <arm_group_label>mild cooking process</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  BMI between 18 an 27&#xD;
&#xD;
          -  Age between 18 and 45 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gastrointestinal or liver pathology&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Vegetarian&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claire Gaudichon, PhD</last_name>
    <role>Study Director</role>
    <affiliation>INRA AgroParisTech</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gheorghe Airinei, MD</last_name>
    <phone>33 1 48 95 74 30</phone>
    <email>gheorghe.airinei@avc.aphp.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre de Recherche sur volontaires</name>
      <address>
        <city>Bobigny</city>
        <zip>93</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gheorghe Airinei</last_name>
      <phone>33 1 48 95 53 34</phone>
      <email>gheorghe.airinei@avc.aphp.fr</email>
    </contact>
    <investigator>
      <last_name>Robert Benamouzig, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>March 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>September 11, 2012</last_update_submitted>
  <last_update_submitted_qc>September 11, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 14, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assistance Publique - Hôpitaux de Paris</investigator_affiliation>
    <investigator_full_name>Robert Benamouzig</investigator_full_name>
    <investigator_title>Manager of the HNRC</investigator_title>
  </responsible_party>
  <keyword>ileal digestibility</keyword>
  <keyword>metabolism</keyword>
  <keyword>stable isotopes</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/NCT01685307
org study id: PRONUTRIAL
nct id: NCT01685307
lead sponsor: 
collaborator: 
has dmc: Yes
Few is known on meat protein digestibility in humans and the impact of cooking process, while
      excessive intake of processed meat has been suggested to increase the risk of colorectal
      cancer.

      This study aims to measure in vivo in humans the real digestibility of beef meat proteins
      depending 2 cooking processes, using ileal tubes and stable isotopes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: protein digestibility
time frame: single measure
description: From ileal recovery of the ingested tracer during 8 h after the meal
measure: nitrogen metabolism
time frame: single measure
description: Distribution of dietary nitrogen throug metabolic pools
arm group label: intense cooking process
arm group type: Experimental
description: Test meal: 150g of beef cooked at intense temperature. Beef proteins are intrinsically labelled with 15 N protein
arm group label: mild cooking process
arm group type: Experimental
description: Test meal: 150 g of beef cooked at moderate intensity. Beef proteins are intrinsically labeled with 15N.
intervention type: Dietary Supplement
intervention name: Test meal
description: test meal is 150 g of beef cooked either at moderate or high intensity. Proteins are intrinsically labelled with 15N.
arm group label: intense cooking process
arm group label: mild cooking process
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Claire Gaudichon, PhD
role: Study Director
affiliation: INRA AgroParisTech
last name: Gheorghe Airinei, MD
phone: 33 1 48 95 74 30
email: gheorghe.airinei@avc.aphp.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Assistance Publique - Hôpitaux de Paris
investigator full name: Robert Benamouzig
investigator title: Manager of the HNRC