<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/NCT03783260</url>
  </required_header>
  <id_info>
    <org_study_id>2018-262</org_study_id>
    <nct_id>NCT03783260</nct_id>
  </id_info>
  <brief_title>Investigation of Microbiome-Derived Metabolite Production in Response to a Mediterranean Diet</brief_title>
  <acronym>META</acronym>
  <official_title>Investigation of Microbiome-Derived Metabolite Production in Response to a Mediterranean Diet</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laval University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laval University</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>
      This project proposes to characterise the microbiome-derived metabolites produced upon&#xD;
      ingestion of bioactive precursor-rich meals by healthy volunteers in order to investigate the&#xD;
      relationship between gut microbiome composition and the nature of dietary metabolites&#xD;
      production.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is a large inter-individual variability in gut microbiome-derived metabolites&#xD;
      production upon ingestion of similar meals. Since many of these microbiome-derived&#xD;
      metabolites have enteric and systemic biological effects, these variabilities could in part&#xD;
      account for the different responses to meals and diets.&#xD;
&#xD;
      This project thus aims to improve the understanding the relationship between gut microbiome&#xD;
      composition and the nature of dietary metabolites produced from similar bioactive&#xD;
      precursor-rich meals.&#xD;
&#xD;
      The investigators therefore propose to characterise the circulating microbiome-derived&#xD;
      metabolite profiles in healthy individuals fed the same 2-day precursor-rich Mediterranean&#xD;
      diet prior to and after a 2-week of habitual Canadian diet feeding.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">April 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Microbiome-derived metabolite profiling</measure>
    <time_frame>19 days</time_frame>
    <description>Plasma and urine metabolomics profiling of gut-microbiome derived metabolites (e.g., branched-chain amino acids [BCAA], short chain fatty acids [SCFA], trimethylamine [TMA], amino acids- and polyphenol-metabolites) will also performed at the same time points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gut microbiome characterisation</measure>
    <time_frame>19 days</time_frame>
    <description>Fecal microbiome composition will be characterise by rRNA 16S sequencing prior to and following both 2-day Mediterranean diet periods. Relevant indexes of microbiome diversity (e.g. Shannon beta-diversity), ratios between meaningful bacterial markers of gut dysbiosis (e.g. Firmicutes:Bacteroidetes) and specific microbiome differences in bacterial Families, Genera or species between study periods and individuals.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Endocannabinoid interaction with interindividual microbiome composition</measure>
    <time_frame>19 days</time_frame>
    <description>Interindividual variations in the endocannabinoid levels following a 2-day Mediterranean diet intervention according to individual gut microbiome composition will also be characterised. N-acyl ethanolamines, acylglycerols and omega-3 derived endocannabinoids will be quantified by LC MS-MS in plasma and urine samples collected prior to and following both 2-day Mediterranean diet periods.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Food Habits</condition>
  <arm_group>
    <arm_group_label>Single</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participating subjects will undergo two, 2-day Mediterranean diet feeding periods separated by a 14-day period of Canadian diet</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mediterranean diet</intervention_name>
    <description>During both Mediterranean diet periods, participants will be provided with meals and snacks representative of the Mediterranean nutritional habits. Participants will be required to eat only the meals provided.</description>
    <arm_group_label>Single</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women aged between 18 and 35 years&#xD;
&#xD;
          -  Body mass index between 18.5 and 30 kg/m2&#xD;
&#xD;
          -  General good health&#xD;
&#xD;
          -  Computer and Internet access&#xD;
&#xD;
          -  Basic understanding of written French&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intestinal pathologies including inflammatory bowel disease and gastrointestinal&#xD;
             cancers&#xD;
&#xD;
          -  Pregnant and/or breast-feeding women&#xD;
&#xD;
          -  Alcohol consumption greater than 15 portions for men and 10 for women weekly&#xD;
&#xD;
          -  Active tobacco usage&#xD;
&#xD;
          -  Consumption of dietary supplements (e.g. multivitamins, omega-3, probiotics)&#xD;
&#xD;
          -  Completion of a course of antibiotics in the past 3 months&#xD;
&#xD;
          -  Regular use of anti-inflammatory drugs, or use in the past 3 months&#xD;
&#xD;
          -  Important weight change (+/- 5 kg) in the past 6 months&#xD;
&#xD;
          -  Allergies or food intolerances to ingredients present in trial diets&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institut sur la nutrition et les aliments fonctionnels - INAF</name>
      <address>
        <city>Québec</city>
        <state>Quebec</state>
        <zip>G1V 0A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>February 27, 2020</last_update_submitted>
  <last_update_submitted_qc>February 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Laval University</investigator_affiliation>
    <investigator_full_name>Alain Veilleux</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Gut Microbiome</keyword>
  <keyword>Metabolites</keyword>
  <keyword>Endocannabinoid</keyword>
  <keyword>Mediterranean diet</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03783260
org study id: 2018-262
nct id: NCT03783260
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This project proposes to characterise the microbiome-derived metabolites produced upon
      ingestion of bioactive precursor-rich meals by healthy volunteers in order to investigate the
      relationship between gut microbiome composition and the nature of dietary metabolites
      production.
There is a large inter-individual variability in gut microbiome-derived metabolites
      production upon ingestion of similar meals. Since many of these microbiome-derived
      metabolites have enteric and systemic biological effects, these variabilities could in part
      account for the different responses to meals and diets.

      This project thus aims to improve the understanding the relationship between gut microbiome
      composition and the nature of dietary metabolites produced from similar bioactive
      precursor-rich meals.

      The investigators therefore propose to characterise the circulating microbiome-derived
      metabolite profiles in healthy individuals fed the same 2-day precursor-rich Mediterranean
      diet prior to and after a 2-week of habitual Canadian diet feeding.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Microbiome-derived metabolite profiling
time frame: 19 days
description: Plasma and urine metabolomics profiling of gut-microbiome derived metabolites (e.g., branched-chain amino acids [BCAA], short chain fatty acids [SCFA], trimethylamine [TMA], amino acids- and polyphenol-metabolites) will also performed at the same time points.
measure: Gut microbiome characterisation
time frame: 19 days
description: Fecal microbiome composition will be characterise by rRNA 16S sequencing prior to and following both 2-day Mediterranean diet periods. Relevant indexes of microbiome diversity (e.g. Shannon beta-diversity), ratios between meaningful bacterial markers of gut dysbiosis (e.g. Firmicutes:Bacteroidetes) and specific microbiome differences in bacterial Families, Genera or species between study periods and individuals.
measure: Endocannabinoid interaction with interindividual microbiome composition
time frame: 19 days
description: Interindividual variations in the endocannabinoid levels following a 2-day Mediterranean diet intervention according to individual gut microbiome composition will also be characterised. N-acyl ethanolamines, acylglycerols and omega-3 derived endocannabinoids will be quantified by LC MS-MS in plasma and urine samples collected prior to and following both 2-day Mediterranean diet periods.
arm group label: Single
arm group type: Experimental
description: All participating subjects will undergo two, 2-day Mediterranean diet feeding periods separated by a 14-day period of Canadian diet
intervention type: Other
intervention name: Mediterranean diet
description: During both Mediterranean diet periods, participants will be provided with meals and snacks representative of the Mediterranean nutritional habits. Participants will be required to eat only the meals provided.
arm group label: Single
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Laval University
investigator full name: Alain Veilleux
investigator title: Professor
sharing ipd: Undecided