<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/NCT03773900</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL18_0362</org_study_id>
    <nct_id>NCT03773900</nct_id>
  </id_info>
  <brief_title>Characterization of Gut Microbiota Composition and Activity After a Daily Supplementation of 4.5 g/Day of ChitinGlucan Fibre During 3 Weeks in At-cardiometabolic Risk Volunteers</brief_title>
  <acronym>FITACHITIN</acronym>
  <official_title>Characterization of Gut Microbiota Composition and Activity After a Daily Supplementation of 4.5 g/Day of ChitinGlucan Fibre During 3 Weeks in At-cardiometabolic Risk Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to demonstrate the beneficial effects on gut microbiota composition&#xD;
      and activity of the diary intake of insoluble fiber (extract from Aspergillus Niger) for&#xD;
      three weeks. The first studies about the fiber have shown a favorable gut microbiota&#xD;
      modulation and an improvement of metabolic parameters like LDL cholesterol. In addition to&#xD;
      fecal measurements, several biomarkers of colic fermentation will be assessed: expired gases,&#xD;
      PolyUnsaturated Fatty Acid, Short Chain Fatty Acid (SCFA) after a rich-fiber breakfast (= 15&#xD;
      grams) and a nutritional challenge test at lunch. The gastrointestinal tolerance of fiber&#xD;
      intake and the intestinal transit modification will be also followed during all the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 7, 2018</start_date>
  <completion_date type="Actual">June 6, 2019</completion_date>
  <primary_completion_date type="Actual">June 6, 2019</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fecal SCFA</measure>
    <time_frame>baseline and three weeks</time_frame>
    <description>Change from baseline fecal SCFA at three weeks by Gas chromatography-Flame Ionization Detector</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>gut microbiota composition</measure>
    <time_frame>baseline and three weeks</time_frame>
    <description>Change from baseline gut microbiota composition by 16SrDNA Illimina Sequencing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fecal biliary acids</measure>
    <time_frame>baseline and three weeks</time_frame>
    <description>Change from baseline fecal biliary acids by FAME quantification (gas-liquid chromatography)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fecal PolyUnsaturated Fatty Acids (PUFA)</measure>
    <time_frame>baseline and three weeks</time_frame>
    <description>Change from baseline fecal PolyUnsaturted Fatty Acids (PUFA) by FAME quantification (gas-liquid chromatography)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fecal albumin</measure>
    <time_frame>baseline and three weeks</time_frame>
    <description>Change from baseline fecal albumin by immunoenzymatic technique (ELISA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fecal zonulin</measure>
    <time_frame>baseline and three weeks</time_frame>
    <description>Change from baseline fecal zonulin by immunoenzymatic technique (IDK Zonulin ELISA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fecal calprotectin</measure>
    <time_frame>baseline and three weeks</time_frame>
    <description>Change from baseline fecal calprotectin by Phadia 100 system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TLR-agonist in stool</measure>
    <time_frame>baseline and three weeks</time_frame>
    <description>Change from baseline TRL-agonist in stool using the HEK-Blue™ TLR cellules</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline CO2, CH4 and H2 kinetics in exhaled gases</measure>
    <time_frame>baseline and three weeks</time_frame>
    <description>by gas chromatography, during ten hours after rich-fiber breakfast and nutritional challenge test at lunch</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>body composition</measure>
    <time_frame>baseline and three weeks</time_frame>
    <description>Change from baseline bodycompositio by bioimpedancemetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from plasma glucose kinetics</measure>
    <time_frame>baseline and three weeks</time_frame>
    <description>by spectrophotometry method , during seven hours after rich-fiber breakfast and nutritional challenge test at lunch</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from plasma insulin kinetics</measure>
    <time_frame>baseline and three weeks</time_frame>
    <description>by radio-immuno analysis , during seven hours after rich-fiber breakfast and nutritional challenge test at lunch</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from plasma Non-Esterifies Fatty-Acid (NEFA) kinetics</measure>
    <time_frame>baseline and three weeks</time_frame>
    <description>by spectrophotometry method , during seven hours after rich-fiber breakfast and nutritional challenge test at lunch</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma TriacylGlycerol (TG) kinetics</measure>
    <time_frame>baseline and three weeks</time_frame>
    <description>Change from plasma TriacylGlycerol (TG) kinetics by spectrophotometry method , during seven hours after rich-fiber breakfast and nutritional challenge test at lunch</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cholesterol Total, Cholesterol LDL</measure>
    <time_frame>baseline and three weeks</time_frame>
    <description>Change from baseline cholesterol Total, Cholesterol LDL by spectrophotometry method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>resting energy expenditure</measure>
    <time_frame>baseline and three weeks</time_frame>
    <description>Change from baseline resting energy expenditure by indirect calorimetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stool consistency</measure>
    <time_frame>every week, up to three weeks</time_frame>
    <description>by Bristol Stool Chart (type1-7)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stool frequency</measure>
    <time_frame>every week, up to three weeks</time_frame>
    <description>by questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>gastro-intestinal symptoms</measure>
    <time_frame>every week, up to three weeks</time_frame>
    <description>by questionnaires and visual analogue scale (VAS) score (on a 90mm horizontal line; from no symptom (minimal) to serious symptom (maximum))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life during the study</measure>
    <time_frame>baseline and three weeks</time_frame>
    <description>change from baseline quality of life during the study by SF 36 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline dietary intake of fibre</measure>
    <time_frame>baseline and three weeks</time_frame>
    <description>by three day food record</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Cardiometabolic Risk</condition>
  <condition>Abdominal Obesity</condition>
  <arm_group>
    <arm_group_label>Chitin-Glucan supplementation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo supplementation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Kiotransine (chitin-glucan from aspergillus niger)</intervention_name>
    <description>The volunteers will take three times a day one bag of powder containing 1.5g of chitin-glucan fiber during three weeks. The powder will be diluted in water.</description>
    <arm_group_label>Chitin-Glucan supplementation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>The volunteers will take three times a day one bag of powder containing placebo during three weeks. The powder will be diluted in water.</description>
    <arm_group_label>Placebo supplementation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  Non-smokers&#xD;
&#xD;
          -  Body mass index between 25 and 35 kg/m2&#xD;
&#xD;
          -  Waist circumference &lt; 80cm for women and &gt; 94 cm for men&#xD;
&#xD;
          -  Fiber intake &lt;25g/day&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical history of digestive surgery or disease&#xD;
&#xD;
          -  Current or recent (&lt;12 weeks) intake of antibiotics or gastro-intestinal medicinal&#xD;
             product&#xD;
&#xD;
          -  Current probiotics, prebiotics, fiber complement, and/or any products modulation gut&#xD;
             transit&#xD;
&#xD;
          -  Feeding particular diet such as vegetarian diet or hyperprotein diet&#xD;
&#xD;
          -  Current weight loss diet&#xD;
&#xD;
          -  Pregnant or lactating woman or woman who did not use effective contraception&#xD;
&#xD;
          -  Drinking more than 3 glasses of alcohol per day (&gt;30g/day)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre de Recherche en Nutrition Humaine Rhône-Alpes - Centre hospitalier Lyon Sud</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69310</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.crnh-rhone-alpes.fr</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>August 12, 2019</last_update_submitted>
  <last_update_submitted_qc>August 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>chitin-glucan</keyword>
  <keyword>gut microbiota</keyword>
  <keyword>Fecal Short Chain Fatty Acid (SCFA)</keyword>
  <keyword>cardiometabolic risk</keyword>
  <keyword>nutritional challenge test</keyword>
  <keyword>biomarkers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Abdominal</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/NCT03773900
org study id: 69HCL18_0362
nct id: NCT03773900
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to demonstrate the beneficial effects on gut microbiota composition
      and activity of the diary intake of insoluble fiber (extract from Aspergillus Niger) for
      three weeks. The first studies about the fiber have shown a favorable gut microbiota
      modulation and an improvement of metabolic parameters like LDL cholesterol. In addition to
      fecal measurements, several biomarkers of colic fermentation will be assessed: expired gases,
      PolyUnsaturated Fatty Acid, Short Chain Fatty Acid (SCFA) after a rich-fiber breakfast (= 15
      grams) and a nutritional challenge test at lunch. The gastrointestinal tolerance of fiber
      intake and the intestinal transit modification will be also followed during all the study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Fecal SCFA
time frame: baseline and three weeks
description: Change from baseline fecal SCFA at three weeks by Gas chromatography-Flame Ionization Detector
measure: gut microbiota composition
time frame: baseline and three weeks
description: Change from baseline gut microbiota composition by 16SrDNA Illimina Sequencing
measure: fecal biliary acids
time frame: baseline and three weeks
description: Change from baseline fecal biliary acids by FAME quantification (gas-liquid chromatography)
measure: fecal PolyUnsaturated Fatty Acids (PUFA)
time frame: baseline and three weeks
description: Change from baseline fecal PolyUnsaturted Fatty Acids (PUFA) by FAME quantification (gas-liquid chromatography)
measure: fecal albumin
time frame: baseline and three weeks
description: Change from baseline fecal albumin by immunoenzymatic technique (ELISA)
measure: fecal zonulin
time frame: baseline and three weeks
description: Change from baseline fecal zonulin by immunoenzymatic technique (IDK Zonulin ELISA)
measure: fecal calprotectin
time frame: baseline and three weeks
description: Change from baseline fecal calprotectin by Phadia 100 system
measure: TLR-agonist in stool
time frame: baseline and three weeks
description: Change from baseline TRL-agonist in stool using the HEK-Blue™ TLR cellules
measure: Change from baseline CO2, CH4 and H2 kinetics in exhaled gases
time frame: baseline and three weeks
description: by gas chromatography, during ten hours after rich-fiber breakfast and nutritional challenge test at lunch
measure: body composition
time frame: baseline and three weeks
description: Change from baseline bodycompositio by bioimpedancemetry
measure: Change from plasma glucose kinetics
time frame: baseline and three weeks
description: by spectrophotometry method , during seven hours after rich-fiber breakfast and nutritional challenge test at lunch
measure: Change from plasma insulin kinetics
time frame: baseline and three weeks
description: by radio-immuno analysis , during seven hours after rich-fiber breakfast and nutritional challenge test at lunch
measure: Change from plasma Non-Esterifies Fatty-Acid (NEFA) kinetics
time frame: baseline and three weeks
description: by spectrophotometry method , during seven hours after rich-fiber breakfast and nutritional challenge test at lunch
measure: plasma TriacylGlycerol (TG) kinetics
time frame: baseline and three weeks
description: Change from plasma TriacylGlycerol (TG) kinetics by spectrophotometry method , during seven hours after rich-fiber breakfast and nutritional challenge test at lunch
measure: Cholesterol Total, Cholesterol LDL
time frame: baseline and three weeks
description: Change from baseline cholesterol Total, Cholesterol LDL by spectrophotometry method
measure: resting energy expenditure
time frame: baseline and three weeks
description: Change from baseline resting energy expenditure by indirect calorimetry
measure: stool consistency
time frame: every week, up to three weeks
description: by Bristol Stool Chart (type1-7)
measure: stool frequency
time frame: every week, up to three weeks
description: by questionnaire
measure: gastro-intestinal symptoms
time frame: every week, up to three weeks
description: by questionnaires and visual analogue scale (VAS) score (on a 90mm horizontal line; from no symptom (minimal) to serious symptom (maximum))
measure: quality of life during the study
time frame: baseline and three weeks
description: change from baseline quality of life during the study by SF 36 questionnaire
measure: change from baseline dietary intake of fibre
time frame: baseline and three weeks
description: by three day food record
arm group label: Chitin-Glucan supplementation
arm group type: Experimental
arm group label: Placebo supplementation
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: Kiotransine (chitin-glucan from aspergillus niger)
description: The volunteers will take three times a day one bag of powder containing 1.5g of chitin-glucan fiber during three weeks. The powder will be diluted in water.
arm group label: Chitin-Glucan supplementation
intervention type: Dietary Supplement
intervention name: Placebo
description: The volunteers will take three times a day one bag of powder containing placebo during three weeks. The powder will be diluted in water.
arm group label: Placebo supplementation
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
url: http://www.crnh-rhone-alpes.fr
description: Related Info
responsible party type: Sponsor
mesh term: Obesity, Abdominal