<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/NCT02221050</url>
  </required_header>
  <id_info>
    <org_study_id>2013/28</org_study_id>
    <nct_id>NCT02221050</nct_id>
  </id_info>
  <brief_title>Hemodialysis and Wanting for Protein-rich Foods</brief_title>
  <official_title>Influence of Chronic Renal Failure and Hemodialysis on Liking and Wanting for Foods</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Burgundy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Burgundy</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study conducted in the laboratory revealed the existence of a &quot;window&quot; during which&#xD;
      patients with renal failure appreciate the protein-rich foods. This period, located&#xD;
      immediately after the dialysis, is likely related to the purification of plasma products&#xD;
      resulting from protein catabolism. It therefore appears necessary to understand the&#xD;
      mechanisms that may explain these changes by measurements of ghrelin (orexigenic hormone),&#xD;
      leptin (anorectic hormone) and plasma amino acids.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In 24 patients with renal failure treated by hemodialysis, it is evaluated (at 8:00 am and at&#xD;
      11:00 am), a day without hemodialysis and another day after the hemodialysis:&#xD;
&#xD;
        -  Hunger sensation,&#xD;
&#xD;
        -  Olfactory liking assessed separately for 6 foods (2 carbohydrate-, 2 fat- and 2&#xD;
           protein-rich foods) and 2 non-alimentary products,&#xD;
&#xD;
        -  Food wanting evaluated by the sequential presentation of 18 images of food (6 fat-, 6&#xD;
           carbohydrate- and 6 protein-rich foods),&#xD;
&#xD;
        -  Two blood samples for the assays of leptin, ghrelin, creatinine, albumin and pre-albumin&#xD;
           as well as plasma amino acids.&#xD;
&#xD;
           24 healthy subjects are also evaluated in order to compare the results from patients to&#xD;
           those of control subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>15 Days</target_duration>
  <primary_outcome>
    <measure>Amount of wanting for protein-rich foods</measure>
    <time_frame>20 min (from 8:00 to 8:20 am) and 20 min (from 11:00 to 11:20 am)</time_frame>
    <description>The wanting is determined after the successive presentation (for ten seconds) of 18 pictures of food. For each food the question is &quot;at the present time, do you want to eat this food? &quot;. For each photo, subjects place a vertical line on a 10 cm horizontal line bounded at its ends by &quot;no desire&quot; and &quot;extremely envy&quot; (visual analog scale).The wanting for proteins is the mean score for the desire to eat protein-rich foods.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concentrations of the plasma amino-acids</measure>
    <time_frame>8:30 am and 11:30 am</time_frame>
    <description>Variation in concentrations of amino-acids during the morning a day with hemodialysis and a day without hemodialysis, and comparison with plasma AAs from healthy subjects</description>
  </secondary_outcome>
  <enrollment type="Actual">48</enrollment>
  <condition>Renal Failure</condition>
  <eligibility>
    <study_pop>
      <textblock>
        hemodialysis centers of Clinique Drevon, Dijon, France la Breuchillière, Saint Apollinaire,&#xD;
        France University Hospital, Dijon, France Macon Hospital, Macon, France&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients and healthy subjects were included if they were aged between 18 and 80 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diabetes, advanced undernutrition (BMI &lt; 17.5 kg m-2, prealbumin &lt; 250 mg.L-1),&#xD;
             congestive heart failure, acute or chronic infection, ongoing antibiotic treatment,&#xD;
             active cancer, liver cirrhosis, smoking (more than 5 cigarettes/day), alcohol&#xD;
             consumption (more than 3 units/day), aversion to the foods eaten or smelt during the&#xD;
             study, impaired comprehension of the cognitive tasks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luc PENICAUD, PHD</last_name>
    <role>Study Director</role>
    <affiliation>Centre des Sciences du Goût, Centre National de la recherche Scientifique</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre des Sciences du Goût</name>
      <address>
        <city>Dijon</city>
        <state>Burgundy</state>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>August 19, 2014</last_update_submitted>
  <last_update_submitted_qc>August 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Burgundy</investigator_affiliation>
    <investigator_full_name>Laurent BRONDEL</investigator_full_name>
    <investigator_title>University professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</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/NCT02221050
org study id: 2013/28
nct id: NCT02221050
lead sponsor: 
has dmc: No
A study conducted in the laboratory revealed the existence of a "window" during which
      patients with renal failure appreciate the protein-rich foods. This period, located
      immediately after the dialysis, is likely related to the purification of plasma products
      resulting from protein catabolism. It therefore appears necessary to understand the
      mechanisms that may explain these changes by measurements of ghrelin (orexigenic hormone),
      leptin (anorectic hormone) and plasma amino acids.
In 24 patients with renal failure treated by hemodialysis, it is evaluated (at 8:00 am and at
      11:00 am), a day without hemodialysis and another day after the hemodialysis:

        -  Hunger sensation,

        -  Olfactory liking assessed separately for 6 foods (2 carbohydrate-, 2 fat- and 2
           protein-rich foods) and 2 non-alimentary products,

        -  Food wanting evaluated by the sequential presentation of 18 images of food (6 fat-, 6
           carbohydrate- and 6 protein-rich foods),

        -  Two blood samples for the assays of leptin, ghrelin, creatinine, albumin and pre-albumin
           as well as plasma amino acids.

           24 healthy subjects are also evaluated in order to compare the results from patients to
           those of control subjects.
observational model: Cohort
time perspective: Cross-Sectional
measure: Amount of wanting for protein-rich foods
time frame: 20 min (from 8:00 to 8:20 am) and 20 min (from 11:00 to 11:20 am)
description: The wanting is determined after the successive presentation (for ten seconds) of 18 pictures of food. For each food the question is "at the present time, do you want to eat this food? ". For each photo, subjects place a vertical line on a 10 cm horizontal line bounded at its ends by "no desire" and "extremely envy" (visual analog scale).The wanting for proteins is the mean score for the desire to eat protein-rich foods.
measure: Concentrations of the plasma amino-acids
time frame: 8:30 am and 11:30 am
description: Variation in concentrations of amino-acids during the morning a day with hemodialysis and a day without hemodialysis, and comparison with plasma AAs from healthy subjects
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Luc PENICAUD, PHD
role: Study Director
affiliation: Centre des Sciences du Goût, Centre National de la recherche Scientifique
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: University of Burgundy
investigator full name: Laurent BRONDEL
investigator title: University professor
mesh term: Renal Insufficiency