<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/NCT02223585</url>
  </required_header>
  <id_info>
    <org_study_id>13.28.MET</org_study_id>
    <nct_id>NCT02223585</nct_id>
  </id_info>
  <brief_title>Gut Microbiota and Proteins Intake</brief_title>
  <official_title>Gut Microbial Response to Well-balanced Diet With Emphasis on Animal or Vegan Protein</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Société des Produits Nestlé (SPN)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Société des Produits Nestlé (SPN)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gut microbiota are involved in the regulation of mammalian metabolic pathways through&#xD;
      host-microbiota metabolic, signaling, and immune-inflammatory interactions that&#xD;
      physiologically connect the gut, liver, brain, and other organs. Correlation of these&#xD;
      metabotypes with gut microbial profiles facilitates deciphering inherent host-microbe&#xD;
      relationships.&#xD;
&#xD;
      Microbiome sequencing have generated novel insights into the role of gut microbial&#xD;
      composition in health and disease, but are limited in addressing the microbial contribution&#xD;
      to host metabolism and the gut microbial dysbiosis in disease.&#xD;
&#xD;
      This is an exploratory trial, aiming to examine how gut microbial conditions determine&#xD;
      response to dietary challenge by measuring urine, plasma and stool metabolites resulting from&#xD;
      metabolism of protein, polyamines and bile acids in combination with stool bacterial&#xD;
      composition. The focus of this trial is to evaluate impact of protein based food challenges,&#xD;
      based on cross-over design of two diet challenges of animal and vegan protein sources.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intra-individual plasma, stools, and urine omics to acute controlled feeding</measure>
    <time_frame>3-Day baseline, 3-Day diet challenge 1, 1-Day baseline after challenge 1 washout, 3-Day diet challenge 2, 1-Day baseline after challenge 2 washout</time_frame>
    <description>Metabonomics on fasting blood, urine, and stools and microbiota composition by 1. defining individual baseline (3-Day baseline before start of diet challenges); 2. Examining effect of the dietary challenges (3-Day diet challenge vs. Baseline); 3. Examining global dietary effect (baseline after challenge 2 vs. baseline after challenge 1) and stability of dietary effect (3rd day of each diet challenge vs. baseline after the challenge)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intra-individual plasma biochemistry response to acute controlled feeding</measure>
    <time_frame>Day 1 and 3 of diet challenge 1, 1-Day baseline after challenge 1 washout, Day 1 and 3 of diet challenge 2, 1-Day baseline after challenge 2 washout</time_frame>
    <description>To evaluate effect of the dietary challenges (Day 3 vs Day1 of each diet challenge), the global dietary effect (baseline after challenge 2 vs. the baseline after challenge 1, Day 1 of diet challenge 1), stability of the dietary effect (3rd day of each diet challenge vs. baseline after the challenge)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subject's omics adaptation phase to a controlled diet Subject's omics adaptation phase to a controlled diet</measure>
    <time_frame>3-Day diet challenge 1 and 2</time_frame>
    <description>Through analysis of metabonomics on fasting blood, daytime blood, urine, and stools and microbiota composition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of intra-individual daytime plasma response amongst diets and free living restricted diets</measure>
    <time_frame>3-Day baseline before start of diet challenges, 3-Day diet challenge 1, 1-Day baseline after challenge 1 washout, 3-Day diet challenge 2, 1-Day baseline after challenge 2 washout</time_frame>
    <description>Through analysis of metabonomics on fasting blood, daytime blood, urine, and stools and microbiota composition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pairing of gut microbial metabolite to gut microbial composition to generate concept on gut functional system to be followed-up in future studies</measure>
    <time_frame>3-Day baseline before start of diet challenges, 3-Day diet challenge 1, 1-Day baseline after challenge 1 washout, 3-Day diet challenge 2, 1-Day baseline after challenge 2 washout</time_frame>
    <description>Through analysis of metabonomics on fasting blood, daytime blood, urine, and stools and microbiota composition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pairing dietary intake and preferences with subjects response in Omics endpoints</measure>
    <time_frame>3-Day baseline before start of diet challenges, 3-Day diet challenge 1, 1-Day baseline after challenge 1 washout, 3-Day diet challenge 2, 1-Day baseline after challenge 2 washout</time_frame>
    <description>Through analysis of metabonomics on fasting blood, daytime blood, urine, and stools and microbiota composition and 3- Days dietary recall during diet challenges and food frequency questionnaire at baseline before start of diet challenges</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Cross-over single arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Animal-based protein diet</intervention_name>
    <arm_group_label>Cross-over single arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vegan-based protein diet</intervention_name>
    <arm_group_label>Cross-over single arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Caucasian&#xD;
&#xD;
          -  Regular bowl movement (at least once every 1-2 days)&#xD;
&#xD;
          -  Between 18 and 55 years old&#xD;
&#xD;
          -  BMI between 18.5 and 27 kg/m2 (inclusive)&#xD;
&#xD;
          -  Willing and able to sign written informed consent prior to trial entry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically relevant digestive, renal or metabolic disease, as determined by the&#xD;
             medical (screening) visit and a standard blood chemistry analysis (glucose, total&#xD;
             cholesterol, LDL, HDL, triglycerides, Aspartate aminotransferase (ASAT), Alanine&#xD;
             aminotransferase (ALAT), gamma glutamyl transferase (Gamma-GT), C reactive protein&#xD;
             (CRP), creatinine)&#xD;
&#xD;
          -  Undergoing regular medical treatment, pain-killers accepted, based on the medical&#xD;
             questionnaire&#xD;
&#xD;
          -  Special diets: vegetarian, high protein or weight loss program (anamnesis)&#xD;
&#xD;
          -  Pregnancy (anamnesis)&#xD;
&#xD;
          -  Food allergy&#xD;
&#xD;
          -  Participation in a cholesterol management program with functional foods like food&#xD;
             supplement enriched in omega-3 fatty acids, dairy products enriched with phytosterols&#xD;
             (margarines, yoghurts), evaluated during the medical visit&#xD;
&#xD;
          -  Practicing more than 5 moderated physical activity per week&#xD;
&#xD;
          -  Smoker (anamnesis)&#xD;
&#xD;
          -  Have a high alcohol consumption (more than 2 drinks/day) (anamnesis)&#xD;
&#xD;
          -  Consumption of illicit drugs, (anamnesis)&#xD;
&#xD;
          -  Having given blood within the last month, or willing to make a blood donation until&#xD;
             one month following the end of the study&#xD;
&#xD;
          -  Subject who cannot be expected to comply with the study procedures, including&#xD;
             consuming the test products.&#xD;
&#xD;
          -  Currently participating or having participated in another clinical trial during the&#xD;
             last month prior to the beginning of this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maurice Beaumont, MD, PhD, PD Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Metabolic Unit, Clinical Development Unit, Nestec</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Metabolic Unit, Clinical Development Unit, Nestec</name>
      <address>
        <city>Lausanne</city>
        <zip>1000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>April 17, 2015</last_update_submitted>
  <last_update_submitted_qc>April 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gut microbial</keyword>
  <keyword>response</keyword>
  <keyword>to protein-based</keyword>
  <keyword>diet</keyword>
  <keyword>challenges</keyword>
  <keyword>population</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/NCT02223585
org study id: 13.28.MET
nct id: NCT02223585
lead sponsor: 
has dmc: No
Gut microbiota are involved in the regulation of mammalian metabolic pathways through
      host-microbiota metabolic, signaling, and immune-inflammatory interactions that
      physiologically connect the gut, liver, brain, and other organs. Correlation of these
      metabotypes with gut microbial profiles facilitates deciphering inherent host-microbe
      relationships.

      Microbiome sequencing have generated novel insights into the role of gut microbial
      composition in health and disease, but are limited in addressing the microbial contribution
      to host metabolism and the gut microbial dysbiosis in disease.

      This is an exploratory trial, aiming to examine how gut microbial conditions determine
      response to dietary challenge by measuring urine, plasma and stool metabolites resulting from
      metabolism of protein, polyamines and bile acids in combination with stool bacterial
      composition. The focus of this trial is to evaluate impact of protein based food challenges,
      based on cross-over design of two diet challenges of animal and vegan protein sources.
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Intra-individual plasma, stools, and urine omics to acute controlled feeding
time frame: 3-Day baseline, 3-Day diet challenge 1, 1-Day baseline after challenge 1 washout, 3-Day diet challenge 2, 1-Day baseline after challenge 2 washout
description: Metabonomics on fasting blood, urine, and stools and microbiota composition by 1. defining individual baseline (3-Day baseline before start of diet challenges); 2. Examining effect of the dietary challenges (3-Day diet challenge vs. Baseline); 3. Examining global dietary effect (baseline after challenge 2 vs. baseline after challenge 1) and stability of dietary effect (3rd day of each diet challenge vs. baseline after the challenge)
measure: Intra-individual plasma biochemistry response to acute controlled feeding
time frame: Day 1 and 3 of diet challenge 1, 1-Day baseline after challenge 1 washout, Day 1 and 3 of diet challenge 2, 1-Day baseline after challenge 2 washout
description: To evaluate effect of the dietary challenges (Day 3 vs Day1 of each diet challenge), the global dietary effect (baseline after challenge 2 vs. the baseline after challenge 1, Day 1 of diet challenge 1), stability of the dietary effect (3rd day of each diet challenge vs. baseline after the challenge)
measure: Subject's omics adaptation phase to a controlled diet Subject's omics adaptation phase to a controlled diet
time frame: 3-Day diet challenge 1 and 2
description: Through analysis of metabonomics on fasting blood, daytime blood, urine, and stools and microbiota composition
measure: Comparison of intra-individual daytime plasma response amongst diets and free living restricted diets
time frame: 3-Day baseline before start of diet challenges, 3-Day diet challenge 1, 1-Day baseline after challenge 1 washout, 3-Day diet challenge 2, 1-Day baseline after challenge 2 washout
description: Through analysis of metabonomics on fasting blood, daytime blood, urine, and stools and microbiota composition
measure: Pairing of gut microbial metabolite to gut microbial composition to generate concept on gut functional system to be followed-up in future studies
time frame: 3-Day baseline before start of diet challenges, 3-Day diet challenge 1, 1-Day baseline after challenge 1 washout, 3-Day diet challenge 2, 1-Day baseline after challenge 2 washout
description: Through analysis of metabonomics on fasting blood, daytime blood, urine, and stools and microbiota composition
measure: Pairing dietary intake and preferences with subjects response in Omics endpoints
time frame: 3-Day baseline before start of diet challenges, 3-Day diet challenge 1, 1-Day baseline after challenge 1 washout, 3-Day diet challenge 2, 1-Day baseline after challenge 2 washout
description: Through analysis of metabonomics on fasting blood, daytime blood, urine, and stools and microbiota composition and 3- Days dietary recall during diet challenges and food frequency questionnaire at baseline before start of diet challenges
arm group label: Cross-over single arm
arm group type: Experimental
intervention type: Other
intervention name: Animal-based protein diet
arm group label: Cross-over single arm
intervention type: Other
intervention name: Vegan-based protein diet
arm group label: Cross-over single arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maurice Beaumont, MD, PhD, PD Dr
role: Principal Investigator
affiliation: Metabolic Unit, Clinical Development Unit, Nestec
facility: 
country: Switzerland
responsible party type: Sponsor