<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/NCT03803709</url>
  </required_header>
  <id_info>
    <org_study_id>190616V1</org_study_id>
    <secondary_id>2017/04JUL/354</secondary_id>
    <nct_id>NCT03803709</nct_id>
  </id_info>
  <brief_title>Dietary Fiber Intake in Alcohol-dependent Patients</brief_title>
  <official_title>Dietary Fiber Intake in Alcohol-dependent Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université Catholique de Louvain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Université Catholique de Louvain</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The alcohol problem affects 7.5% of the population in Europe and represents a major public&#xD;
      health problem. Alcoholism is also a major cause of undernutrition. Diet is a major factor&#xD;
      influencing the composition of the intestinal microbiota and previous studies, carried out at&#xD;
      Saint-Luc clinics and catholic university of Louvain, show that alcoholic patients suffer&#xD;
      from dysbiosis, that is a significant alteration of the gut microbiota. The investigator's&#xD;
      preliminary studies, carried out at the Integrated Unit of Hepatology of Saint-Luc Clinics,&#xD;
      have shown that alcohol represents more than 40% of total caloric intake in alcohol-dependent&#xD;
      patients. In addition, alcoholic patients have an insufficient intake of dietary fiber, that&#xD;
      is to say a contribution lower than the Belgian nutritional recommendations. Indeed, the&#xD;
      Conseil Supérieur de la Santé recommends a total amount of dietary fiber equal to or greater&#xD;
      than 25 grams per day to ensure correct intestinal function. Fructan-type dietary fiber&#xD;
      (inulin and fructo-oligosaccharides) is found naturally in many fruits and vegetables&#xD;
      (Jerusalem artichokes, asparagus, artichokes, onions, garlic, chicory roots, bananas). They&#xD;
      are neither absorbed nor digested by human enzymes but fermented selectively by intestinal&#xD;
      bacteria.&#xD;
&#xD;
      A good digestive tolerance to dietary fiber supplementation has been observed in healthy&#xD;
      subjects as well as in obese patients, in previous studies conducted at catholic university&#xD;
      of Louvain and Saint-Luc clinics. However, a nutritional rebalance via fiber supplementation&#xD;
      and digestive fiber tolerance have never been tested in an alcohol-dependent population.&#xD;
&#xD;
      The primary objectives of this academic research project in nutrition, carried out in&#xD;
      alcohol-dependent patients, are as follows:&#xD;
&#xD;
        1. restore a nutritional balance as recommended by the Conseil Supérieur de la Santé via a&#xD;
           dietary fiber intake&#xD;
&#xD;
        2. to study digestive tolerance to fibers&#xD;
&#xD;
        3. to study the intestinal and psychological well-being related to a fiber intake&#xD;
&#xD;
      Depending on the results obtained during the achievement of the primary objectives, the&#xD;
      biological samples (blood, stool) collected during the study will be used to analyze the&#xD;
      composition of the intestinal microbiota and the plasma markers associated with intestinal&#xD;
      function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 4, 2017</start_date>
  <completion_date type="Anticipated">July 2022</completion_date>
  <primary_completion_date type="Anticipated">July 2022</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>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in diet profile</measure>
    <time_frame>on Day 2 and Day 19</time_frame>
    <description>This tool is based on the one adapted to alcoholic patients at Saint Luc Hospital. It consists of two parts to allow cross-checking of data (redundancy) and to measure separate information:&#xD;
General: it is implemented a Food Frequency Questionnaire (FFQ) in order to investigate the general diet profile.&#xD;
Daily: it resumes the sequencing of a full day which allows to verify the information previously obtained as well as to precisely identify the moments of consumption of alcoholic and non-alcoholic inputs.&#xD;
This 7-day recall will be carried out at two times: week T1 for reminder of the week before hospitalization then T2 for reminder of the week back home. In this last case, this anamnesis will be done by interview, but also on the basis of the diary filled by the patient in T2, in order to optimize the accuracy of the data.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Alimentary book</measure>
    <time_frame>From day 1 to day 21</time_frame>
    <description>The patient will have to fill in this book every day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantitative evaluation of intakes</measure>
    <time_frame>on Day 2 and Day 19</time_frame>
    <description>The meals will be weighted before and after eating</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alimentation history</measure>
    <time_frame>On day 21</time_frame>
    <description>This questionnaire makes it possible to further investigate the patient's diet before the episode of alcoholism in his adult and child life. The aim is to assess whether it is closer to a healthy diet (Mediterranean diet or dash diet) or a Western diet type. It is based on the recall technique and performed by a qualified dietician.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mood</measure>
    <time_frame>on Day 2 and Day 19</time_frame>
    <description>Beck Depression Inventory (score 0-63). Higher score indicates higher depression level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in anxiety</measure>
    <time_frame>on Day 2 and Day 19</time_frame>
    <description>State-Trait Anxiety Inventory (score 20-80). Higher score indicates higher anxiety level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in alcohol craving</measure>
    <time_frame>on Day 2 and Day 19</time_frame>
    <description>Obsessive Compulsive Drinking Scale: a total score (= obsession + compulsion) (0-40) and 2 sub-scores (Obsession (0-20) and Compulsion (0-20)) are calculated. Higher score indicates higher craving level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in impulsivity</measure>
    <time_frame>on Day 2 and Day 19</time_frame>
    <description>Urgency Premeditation Perseverance Sensation seeking impulsive behavior scale: score of different subscales are calculated: &quot;urgency&quot;(0-48), &quot;lack of premeditation&quot;(0-44), &quot;lack of perseverance&quot;(0-40), &quot;sensation seeking&quot;(0-48). Higher score in the different subscales indicates higher impulsivity level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in selective attention</measure>
    <time_frame>on Day 2 and Day 19</time_frame>
    <description>William Lennox attention tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in work memory</measure>
    <time_frame>on Day 2 and Day 19</time_frame>
    <description>Brown-Peterson's tasks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in flexibility</measure>
    <time_frame>on Day 2 and Day 19</time_frame>
    <description>Trail making test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in inhibition</measure>
    <time_frame>on Day 2 and Day 19</time_frame>
    <description>Scoop's tasks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in decision making</measure>
    <time_frame>on Day 2 and Day 19</time_frame>
    <description>Iowa gambling's task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in trauma</measure>
    <time_frame>on Day 2 and Day 19</time_frame>
    <description>Post-traumatic diagnostic scale: calculation of score is complex and described in the related publication Hearn, M, Ceschi, G., Brillon, P, Fürst, G., &amp; Van der Linden, M. (2012). A French adaptation of the Post-traumatic Diagnostic scale. Canadian Journal of Behavioural Science, 44, 16-28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in intestine integrity</measure>
    <time_frame>on Day 2 and Day 19</time_frame>
    <description>It will be determined by blood sample (LPS level)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in albumin, pre-albumin and zinc concentration</measure>
    <time_frame>on Day 2 and Day 19</time_frame>
    <description>It will be determined by blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in intestinal permeability</measure>
    <time_frame>on Day 2 and Day 19</time_frame>
    <description>Patients will ingest 50microCurie of 51Chrome-Ethylenediamintetraacetic prepared in a Nutridrink®. This molecule is not normally absorbed by the intestine except when there is an increase in intestinal permeability (paracellular passage following rupture of tight junctions). The molecule is then filtered by the kidney and is found in the urine. A 24h urine collection will be carried out to measure the radioactivity emitted by 51Chrome-Ethylenediamintetraacetic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fecal albumin concentration</measure>
    <time_frame>on Day 2 and Day 19</time_frame>
    <description>A stool sample will be collected to analyze a marker of intestinal permeability: fecal albumin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intestinal permeability</measure>
    <time_frame>On day 3</time_frame>
    <description>a duodenal biopsy will be collected and the expression of the tight junctions regulating the intestinal permeability will be analyzed by sectional immunofluorescence and quantitative Polymerase Chain reaction</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Alcoholism</condition>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>maltodextrin received at 4g/day on day 3 and 4&#xD;
maltodextrin received at 8g/day from day 5 to 14&#xD;
maltodextrin received at 16g/day from day 15 to 20</description>
  </arm_group>
  <arm_group>
    <arm_group_label>inulin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>inulin received at 4g/day on day 3 and 4&#xD;
inulin received at 8g/day from day 5 to 14&#xD;
inulin received at 16g/day from day 15 to 20</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>inulin</intervention_name>
    <description>inulin given at different dosis from day 3 to day 20</description>
    <arm_group_label>inulin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>maltodextrine given at different dosis from day 3 to day 20</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male or female&#xD;
&#xD;
          -  aged between 18 and 65&#xD;
&#xD;
          -  caucasian&#xD;
&#xD;
          -  French speaking&#xD;
&#xD;
          -  alcohol drunk less than 48h before day 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  another addiction, except smoking&#xD;
&#xD;
          -  psychiatric comorbidity on axe 1 of Diagnostic and Statistical Manual-IV&#xD;
&#xD;
          -  antibiotic, probiotic or fibers recent (&lt;2 months) treatment (or other molecule&#xD;
             modifying intestinal transit)&#xD;
&#xD;
          -  Non-steroidial anti-inflammatory drug or glucocorticoids recently taken (&lt;1 month)&#xD;
&#xD;
          -  obesity: Body Mass Index&lt;30&#xD;
&#xD;
          -  bariatric surgery&#xD;
&#xD;
          -  Type 1 or 2 diabetes&#xD;
&#xD;
          -  chronic inflammatory diseases (Crohn disease, coeliac disease, rheumatoid arthritis)&#xD;
&#xD;
          -  cirrhosis or Advanced hepatic fibrosis (Fibroscan &gt; or = F3)&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Peter Stärkel, MD, PhD</last_name>
    <phone>003227642853</phone>
    <email>peter.starkel@uclouvain.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>Université catholique de Louvain</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Stärkel, MD, PhD</last_name>
      <phone>003227642853</phone>
      <email>peter.starkel@uclouvain.be</email>
    </contact>
    <investigator>
      <last_name>Peter Stärkel, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nathalie Delzenne, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sophie Leclercq, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Philippe de Timary, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>February 5, 2019</last_update_submitted>
  <last_update_submitted_qc>February 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dietary fibers</keyword>
  <keyword>alcohol-dependent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03803709
org study id: 190616V1
secondary id: 2017/04JUL/354
nct id: NCT03803709
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The alcohol problem affects 7.5% of the population in Europe and represents a major public
      health problem. Alcoholism is also a major cause of undernutrition. Diet is a major factor
      influencing the composition of the intestinal microbiota and previous studies, carried out at
      Saint-Luc clinics and catholic university of Louvain, show that alcoholic patients suffer
      from dysbiosis, that is a significant alteration of the gut microbiota. The investigator's
      preliminary studies, carried out at the Integrated Unit of Hepatology of Saint-Luc Clinics,
      have shown that alcohol represents more than 40% of total caloric intake in alcohol-dependent
      patients. In addition, alcoholic patients have an insufficient intake of dietary fiber, that
      is to say a contribution lower than the Belgian nutritional recommendations. Indeed, the
      Conseil Supérieur de la Santé recommends a total amount of dietary fiber equal to or greater
      than 25 grams per day to ensure correct intestinal function. Fructan-type dietary fiber
      (inulin and fructo-oligosaccharides) is found naturally in many fruits and vegetables
      (Jerusalem artichokes, asparagus, artichokes, onions, garlic, chicory roots, bananas). They
      are neither absorbed nor digested by human enzymes but fermented selectively by intestinal
      bacteria.

      A good digestive tolerance to dietary fiber supplementation has been observed in healthy
      subjects as well as in obese patients, in previous studies conducted at catholic university
      of Louvain and Saint-Luc clinics. However, a nutritional rebalance via fiber supplementation
      and digestive fiber tolerance have never been tested in an alcohol-dependent population.

      The primary objectives of this academic research project in nutrition, carried out in
      alcohol-dependent patients, are as follows:

        1. restore a nutritional balance as recommended by the Conseil Supérieur de la Santé via a
           dietary fiber intake

        2. to study digestive tolerance to fibers

        3. to study the intestinal and psychological well-being related to a fiber intake

      Depending on the results obtained during the achievement of the primary objectives, the
      biological samples (blood, stool) collected during the study will be used to analyze the
      composition of the intestinal microbiota and the plasma markers associated with intestinal
      function.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Change in diet profile
time frame: on Day 2 and Day 19
description: This tool is based on the one adapted to alcoholic patients at Saint Luc Hospital. It consists of two parts to allow cross-checking of data (redundancy) and to measure separate information:
General: it is implemented a Food Frequency Questionnaire (FFQ) in order to investigate the general diet profile.
Daily: it resumes the sequencing of a full day which allows to verify the information previously obtained as well as to precisely identify the moments of consumption of alcoholic and non-alcoholic inputs.
This 7-day recall will be carried out at two times: week T1 for reminder of the week before hospitalization then T2 for reminder of the week back home. In this last case, this anamnesis will be done by interview, but also on the basis of the diary filled by the patient in T2, in order to optimize the accuracy of the data.
measure: Alimentary book
time frame: From day 1 to day 21
description: The patient will have to fill in this book every day
measure: Quantitative evaluation of intakes
time frame: on Day 2 and Day 19
description: The meals will be weighted before and after eating
measure: Alimentation history
time frame: On day 21
description: This questionnaire makes it possible to further investigate the patient's diet before the episode of alcoholism in his adult and child life. The aim is to assess whether it is closer to a healthy diet (Mediterranean diet or dash diet) or a Western diet type. It is based on the recall technique and performed by a qualified dietician.
measure: Change in mood
time frame: on Day 2 and Day 19
description: Beck Depression Inventory (score 0-63). Higher score indicates higher depression level.
measure: Change in anxiety
time frame: on Day 2 and Day 19
description: State-Trait Anxiety Inventory (score 20-80). Higher score indicates higher anxiety level.
measure: Change in alcohol craving
time frame: on Day 2 and Day 19
description: Obsessive Compulsive Drinking Scale: a total score (= obsession + compulsion) (0-40) and 2 sub-scores (Obsession (0-20) and Compulsion (0-20)) are calculated. Higher score indicates higher craving level.
measure: Change in impulsivity
time frame: on Day 2 and Day 19
description: Urgency Premeditation Perseverance Sensation seeking impulsive behavior scale: score of different subscales are calculated: "urgency"(0-48), "lack of premeditation"(0-44), "lack of perseverance"(0-40), "sensation seeking"(0-48). Higher score in the different subscales indicates higher impulsivity level.
measure: Change in selective attention
time frame: on Day 2 and Day 19
description: William Lennox attention tests
measure: Change in work memory
time frame: on Day 2 and Day 19
description: Brown-Peterson's tasks
measure: Change in flexibility
time frame: on Day 2 and Day 19
description: Trail making test
measure: Change in inhibition
time frame: on Day 2 and Day 19
description: Scoop's tasks
measure: Change in decision making
time frame: on Day 2 and Day 19
description: Iowa gambling's task
measure: Change in trauma
time frame: on Day 2 and Day 19
description: Post-traumatic diagnostic scale: calculation of score is complex and described in the related publication Hearn, M, Ceschi, G., Brillon, P, Fürst, G., & Van der Linden, M. (2012). A French adaptation of the Post-traumatic Diagnostic scale. Canadian Journal of Behavioural Science, 44, 16-28.
measure: Change in intestine integrity
time frame: on Day 2 and Day 19
description: It will be determined by blood sample (LPS level)
measure: Change in albumin, pre-albumin and zinc concentration
time frame: on Day 2 and Day 19
description: It will be determined by blood sample
measure: Change in intestinal permeability
time frame: on Day 2 and Day 19
description: Patients will ingest 50microCurie of 51Chrome-Ethylenediamintetraacetic prepared in a Nutridrink®. This molecule is not normally absorbed by the intestine except when there is an increase in intestinal permeability (paracellular passage following rupture of tight junctions). The molecule is then filtered by the kidney and is found in the urine. A 24h urine collection will be carried out to measure the radioactivity emitted by 51Chrome-Ethylenediamintetraacetic
measure: Change in fecal albumin concentration
time frame: on Day 2 and Day 19
description: A stool sample will be collected to analyze a marker of intestinal permeability: fecal albumin
measure: Intestinal permeability
time frame: On day 3
description: a duodenal biopsy will be collected and the expression of the tight junctions regulating the intestinal permeability will be analyzed by sectional immunofluorescence and quantitative Polymerase Chain reaction
arm group label: placebo
arm group type: Placebo Comparator
description: maltodextrin received at 4g/day on day 3 and 4
maltodextrin received at 8g/day from day 5 to 14
maltodextrin received at 16g/day from day 15 to 20
arm group label: inulin
arm group type: Experimental
description: inulin received at 4g/day on day 3 and 4
inulin received at 8g/day from day 5 to 14
inulin received at 16g/day from day 15 to 20
intervention type: Dietary Supplement
intervention name: inulin
description: inulin given at different dosis from day 3 to day 20
arm group label: inulin
intervention type: Dietary Supplement
intervention name: placebo
description: maltodextrine given at different dosis from day 3 to day 20
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Peter Stärkel, MD, PhD
phone: 003227642853
email: peter.starkel@uclouvain.be
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Belgium
responsible party type: Sponsor
mesh term: Alcoholism
sharing ipd: No