<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/NCT03266536</url>
  </required_header>
  <id_info>
    <org_study_id>16-006388</org_study_id>
    <nct_id>NCT03266536</nct_id>
  </id_info>
  <brief_title>Small Bowel Microbiota Characterization in Healthy Individuals Before and After Consumption of a Western Diet</brief_title>
  <acronym>Microbiota</acronym>
  <official_title>Small Bowel Microbiota Characterization in Healthy Individuals Before and After Consumption of a Western Diet</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Colorado State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Does the small bowel microbiota in healthy individuals change after consumption of a Western&#xD;
      diet?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The gut microbiota is increasingly being implicated in disease. However, due to difficulty&#xD;
      accessing the small bowel (i.e. requiring upper endoscopy) and the relative paucity of&#xD;
      bacteria in this area (secondary to luminal flow and bactericidal bile acids/gastric acid),&#xD;
      the small bowel microbiota is infrequently evaluated in any studies of this nature. The small&#xD;
      bowel microbiota continues to remain an unexplored area of the gastrointestinal tract.&#xD;
      Characterization of the microbial community and its function is the first step in determining&#xD;
      how it potentially affects health and disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2017</start_date>
  <completion_date type="Actual">May 19, 2017</completion_date>
  <primary_completion_date type="Actual">May 16, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Transcriptional changes in gut microbiota present in stool.</measure>
    <time_frame>Baseline, approximately three weeks.</time_frame>
    <description>DNA extraction from stool samples will be done using standard assays.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Small Intestine Bacteria</condition>
  <arm_group>
    <arm_group_label>No western diet</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will undergo one-time testing for blood, urine, stool, and upper endoscopy with small bowel aspirates and biopsies. Participants will be finished with testing after the upper endoscopy is complete.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Western diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will undergo a first day of testing for blood, urine, stool, and upper endoscopy with small bowel aspirates and biopsies. Participants will then consume a Western diet for 7 days before a second day of identical testing (blood, urine, stool, and upper endoscopy with small bowel aspirates and biopsies).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Western diet</intervention_name>
    <description>Western diet for 7 days: the meals in this Western diet will be provided by the Clinical Research and Trials Unit (CRTU) after participants meet with the nutrition staff (to discuss food preferences, how to obtain the meals). The meals will reflect a typical Western diet: a low fiber, high sugar diet with weight maintenance calories with &lt; 10 grams fiber per day, and a typical US macronutrient calorie distribution of 50% carbs, 35% fat and 15% protein, with no alcohol. At least 50% of carbohydrates will be provided as simple sugars.</description>
    <arm_group_label>Western diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults between (and including) 18-65 years old.&#xD;
&#xD;
          -  On a baseline healthy diet characterized by:&#xD;
&#xD;
               -  High fiber of ≥ 14 g/1000 calories/day&#xD;
&#xD;
               -  &lt; 10% of daily calories from added sugar&#xD;
&#xD;
               -  At least 5 servings of fruit and vegetables per day&#xD;
&#xD;
               -  &lt; or = 13% of daily calories from saturated fat&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who do not meet the above diet requirements.&#xD;
&#xD;
          -  Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or&#xD;
             other inflammatory conditions.&#xD;
&#xD;
          -  Presence of abdominal symptoms based on baseline questionnaire.&#xD;
&#xD;
          -  Commercial oral antibiotic or probiotic use within the past 4 weeks.&#xD;
&#xD;
          -  Pregnancy or plans to become pregnant within the study time frame&#xD;
&#xD;
          -  Vulnerable adults&#xD;
&#xD;
          -  Any other disease(s), condition(s) or habit(s) that would interfere with completion of&#xD;
             study, or in the judgment of the investigator would potentially interfere with&#xD;
             compliance to this study or would adversely affect study outcomes.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Purna C Kashyap, M.B.B.S.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>October 26, 2016</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>May 3, 2022</last_update_submitted>
  <last_update_submitted_qc>May 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Purna C. Kashyap, MBBS</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Gut microbiota</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Principal investigator will protect the safety of subjects, the validity of data and the integrity of the research by assigning a study identification number to the subject. All information will be kept in a locked file cabinet and all data will be in a password protected computer database. All specimens will be stored in the principal investigator's freezer.</ipd_description>
  </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/NCT03266536
org study id: 16-006388
nct id: NCT03266536
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Does the small bowel microbiota in healthy individuals change after consumption of a Western
      diet?
The gut microbiota is increasingly being implicated in disease. However, due to difficulty
      accessing the small bowel (i.e. requiring upper endoscopy) and the relative paucity of
      bacteria in this area (secondary to luminal flow and bactericidal bile acids/gastric acid),
      the small bowel microbiota is infrequently evaluated in any studies of this nature. The small
      bowel microbiota continues to remain an unexplored area of the gastrointestinal tract.
      Characterization of the microbial community and its function is the first step in determining
      how it potentially affects health and disease.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Transcriptional changes in gut microbiota present in stool.
time frame: Baseline, approximately three weeks.
description: DNA extraction from stool samples will be done using standard assays.
arm group label: No western diet
arm group type: No Intervention
description: Participants will undergo one-time testing for blood, urine, stool, and upper endoscopy with small bowel aspirates and biopsies. Participants will be finished with testing after the upper endoscopy is complete.
arm group label: Western diet
arm group type: Experimental
description: Participants will undergo a first day of testing for blood, urine, stool, and upper endoscopy with small bowel aspirates and biopsies. Participants will then consume a Western diet for 7 days before a second day of identical testing (blood, urine, stool, and upper endoscopy with small bowel aspirates and biopsies).
intervention type: Behavioral
intervention name: Western diet
description: Western diet for 7 days: the meals in this Western diet will be provided by the Clinical Research and Trials Unit (CRTU) after participants meet with the nutrition staff (to discuss food preferences, how to obtain the meals). The meals will reflect a typical Western diet: a low fiber, high sugar diet with weight maintenance calories with < 10 grams fiber per day, and a typical US macronutrient calorie distribution of 50% carbs, 35% fat and 15% protein, with no alcohol. At least 50% of carbohydrates will be provided as simple sugars.
arm group label: Western diet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Purna C Kashyap, M.B.B.S.
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Purna C. Kashyap, MBBS
investigator title: Principal Investigator
sharing ipd: No
ipd description: Principal investigator will protect the safety of subjects, the validity of data and the integrity of the research by assigning a study identification number to the subject. All information will be kept in a locked file cabinet and all data will be in a password protected computer database. All specimens will be stored in the principal investigator's freezer.