<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/NCT03042494</url>
  </required_header>
  <id_info>
    <org_study_id>REB16-0388</org_study_id>
    <nct_id>NCT03042494</nct_id>
  </id_info>
  <brief_title>Effect of Prebiotic Intake on Gut Microbiota in Healthy Adults</brief_title>
  <official_title>Effect of Prebiotic Intake on Gut Microbiota in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>General Mills</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Calgary</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>
      In recent years, the importance of the gut microbiota to human health has been demonstrated.&#xD;
      In adulthood, the microbial profile is relatively stable, yet can be transiently altered by&#xD;
      factors such as diet or antibiotic treatment. Such changes may be beneficial, as gut&#xD;
      microbiota has been shown to differ in normal versus disease states including inflammatory&#xD;
      bowel disease, obesity, type 2 diabetes and fatty liver disease. Given this relationship,&#xD;
      there is intense interest in designing interventions that positively influence the gut&#xD;
      microbial profile. Prebiotics are non-digestible, fermentable oligo- and polysaccharides that&#xD;
      alter the colonic environment in favour of health-promoting bacterial species, such as&#xD;
      bifidobacteria which selectively ferment prebiotics. Given the ability of prebiotics to&#xD;
      beneficially alter the microbial profile, there is a need to identify the dosing requirements&#xD;
      to positively modulate the gut microbiota. This study will test the effect of two doses of&#xD;
      prebiotic on gut microbiota taxonomy and diversity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective is to determine the effect of 4 week intake of a moderate dose (7 g/d)&#xD;
      or low dose (2.5-3 g/d) of prebiotic on gut microbiota profiles in healthy adults compared to&#xD;
      a non-prebiotic containing control.&#xD;
&#xD;
      The primary outcome is change in microbial composition (measured via 16S rRNA sequencing).&#xD;
&#xD;
      The secondary outcomes are change in gastrointestinal (GI) tolerance (measured via&#xD;
      questionnaire); change in fecal short chain fatty acids; and change in quality of life.&#xD;
&#xD;
      This study will consist of two separate trials of 12 week duration. Each trial will be&#xD;
      performed in a double-blind, randomized, placebo-controlled crossover manner with a 4 week&#xD;
      intervention period followed by a 4 week wash-out period and final 4 week cross over.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2016</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">May 25, 2017</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>
    <intervention_model_description>Crossover design with 4 week washout period.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in baseline fecal bifidobacteria at 4 weeks</measure>
    <time_frame>4 weeks in cross-over design</time_frame>
    <description>Assessed with 16S rRNA sequencing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in baseline fecal short chain fatty acid concentrations at 4 weeks</measure>
    <time_frame>4 weeks in cross-over design</time_frame>
    <description>Analyzed with gas chromatography/mass spectrophotometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in baseline gastrointestinal tolerance at 4 weeks</measure>
    <time_frame>4 weeks in cross-over design</time_frame>
    <description>Analyzed with questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in baseline quality of life rating at 4 weeks</measure>
    <time_frame>4 weeks in cross-over design</time_frame>
    <description>Measured with SF-36 questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Isocaloric food without the test prebiotic.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prebiotic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prebiotic consumed as one daily serving of 7 g in Group 1 and consumed as one daily serving of 2.5-3 g in Group 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Isocaloric food without the test prebiotic.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Prebiotic</intervention_name>
    <description>Prebiotic consumed as 7 g/d in a snack food in Group 1 and consumed as 2.5-3 g/d in a snack food in Group 2.</description>
    <arm_group_label>Prebiotic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and female subjects who are regular snack consumers&#xD;
&#xD;
          -  Not obese (BMI ≥ 18.5 kg/m2 and ≤ 29.9 kg/m2)&#xD;
&#xD;
          -  18 and 65 years of age&#xD;
&#xD;
          -  Stable bodyweight for at least 3-months prior to the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic disease including but not limited to type 1 or 2 diabetes, cardiovascular&#xD;
             disease, liver or pancreas disease.&#xD;
&#xD;
          -  Major gastrointestinal surgery&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Antibiotic use in the preceding 3 months&#xD;
&#xD;
          -  Currently consume probiotic or prebiotics supplements&#xD;
&#xD;
          -  Currently consume more than 15 g/d of fiber in women and 18 g/d in men&#xD;
&#xD;
          -  Are following a diet or exercise regime designed for weight loss&#xD;
&#xD;
          -  Have a BMI greater than 29.9 kg/m2.&#xD;
&#xD;
          -  Subjects who are required to start an antibiotic regime during the study will be&#xD;
             withdrawn.&#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>Raylene Reimer, PhD, RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 1N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Calgary</investigator_affiliation>
    <investigator_full_name>Dr. Raylene Reimer</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Prebiotic</keyword>
  <keyword>Gut microbiota</keyword>
  <keyword>Dietary fiber</keyword>
  <keyword>Gastrointestinal tolerance</keyword>
  <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/NCT03042494
org study id: REB16-0388
nct id: NCT03042494
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In recent years, the importance of the gut microbiota to human health has been demonstrated.
      In adulthood, the microbial profile is relatively stable, yet can be transiently altered by
      factors such as diet or antibiotic treatment. Such changes may be beneficial, as gut
      microbiota has been shown to differ in normal versus disease states including inflammatory
      bowel disease, obesity, type 2 diabetes and fatty liver disease. Given this relationship,
      there is intense interest in designing interventions that positively influence the gut
      microbial profile. Prebiotics are non-digestible, fermentable oligo- and polysaccharides that
      alter the colonic environment in favour of health-promoting bacterial species, such as
      bifidobacteria which selectively ferment prebiotics. Given the ability of prebiotics to
      beneficially alter the microbial profile, there is a need to identify the dosing requirements
      to positively modulate the gut microbiota. This study will test the effect of two doses of
      prebiotic on gut microbiota taxonomy and diversity.
The primary objective is to determine the effect of 4 week intake of a moderate dose (7 g/d)
      or low dose (2.5-3 g/d) of prebiotic on gut microbiota profiles in healthy adults compared to
      a non-prebiotic containing control.

      The primary outcome is change in microbial composition (measured via 16S rRNA sequencing).

      The secondary outcomes are change in gastrointestinal (GI) tolerance (measured via
      questionnaire); change in fecal short chain fatty acids; and change in quality of life.

      This study will consist of two separate trials of 12 week duration. Each trial will be
      performed in a double-blind, randomized, placebo-controlled crossover manner with a 4 week
      intervention period followed by a 4 week wash-out period and final 4 week cross over.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Crossover design with 4 week washout period.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in baseline fecal bifidobacteria at 4 weeks
time frame: 4 weeks in cross-over design
description: Assessed with 16S rRNA sequencing.
measure: Change in baseline fecal short chain fatty acid concentrations at 4 weeks
time frame: 4 weeks in cross-over design
description: Analyzed with gas chromatography/mass spectrophotometry
measure: Change in baseline gastrointestinal tolerance at 4 weeks
time frame: 4 weeks in cross-over design
description: Analyzed with questionnaire
measure: Change in baseline quality of life rating at 4 weeks
time frame: 4 weeks in cross-over design
description: Measured with SF-36 questionnaire
arm group label: Control
arm group type: Placebo Comparator
description: Isocaloric food without the test prebiotic.
arm group label: Prebiotic
arm group type: Experimental
description: Prebiotic consumed as one daily serving of 7 g in Group 1 and consumed as one daily serving of 2.5-3 g in Group 2.
intervention type: Dietary Supplement
intervention name: Control
description: Isocaloric food without the test prebiotic.
arm group label: Control
intervention type: Dietary Supplement
intervention name: Prebiotic
description: Prebiotic consumed as 7 g/d in a snack food in Group 1 and consumed as 2.5-3 g/d in a snack food in Group 2.
arm group label: Prebiotic
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Raylene Reimer, PhD, RD
role: Principal Investigator
affiliation: University of Calgary
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Calgary
investigator full name: Dr. Raylene Reimer
investigator title: Professor
sharing ipd: No