<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/NCT04498455</url>
  </required_header>
  <id_info>
    <org_study_id>1255329-5</org_study_id>
    <nct_id>NCT04498455</nct_id>
  </id_info>
  <brief_title>Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency</brief_title>
  <official_title>Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baylor 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>
      A randomized placebo controlled trial to determine if increased dietary fiber will prevent&#xD;
      weight gain, inhibit adiposity and reduce perceived stress levels in residents at the Waco&#xD;
      Family Health Center as the result of changes in distal gut microbiota composition and&#xD;
      function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will utilize a single blind, placebo controlled, parallel design to assess the&#xD;
      effect of dietary fiber [Prebiotin] on the gut microbiome, perceived stress, anthropometric&#xD;
      variables, and clinical biomarkers of metabolism. All participants in this study will be&#xD;
      resident physicians at the Family Health Center in Waco, TX. This population was selected&#xD;
      based on pilot data indicating they are at a greater risk for weight gain and have higher&#xD;
      levels of stress than the average population. The goal is to recruit 40 participants for a 12&#xD;
      week intervention trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 30, 2018</start_date>
  <completion_date type="Actual">February 15, 2019</completion_date>
  <primary_completion_date type="Actual">February 14, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized placebo-controlled trial of a fiber supplement [Prebiotin] compared to placebo [maltodextrin]</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>12 weeks</time_frame>
    <description>The investigators will use the following procedure to assess the effect of Prebiotin (OEI) on changes in body weight: there will be two test days: a) baseline (Day 0), prior to randomization to OEI or placebo; and b) week 12, following the 11 week course of OEI/placebo treatment. The investigators will use OEI for the inulin challenge. Change in body weight will be quantified by bio electrical impedance.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Weight Gain Trajectory</condition>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Dietary Supplement: Placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prebiotin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dietary Supplement: Prebiotin (oligofructose enriched inulin)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Prebiotin</intervention_name>
    <description>Fructo-oligosaccharide dietary supplement powder</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Prebiotin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Currently a resident in training at the Family Health Center in their first year.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Currently on prescribed metformin or NSAIDS&#xD;
&#xD;
          -  A diagnosed gastro-intestinal disease (i.e. irritable bowel syndrome or Crohn's&#xD;
             disease)&#xD;
&#xD;
          -  Known allergy to the supplement, placebo, or provided meal replacements&#xD;
&#xD;
          -  Antibiotic use within the last 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>LesLee Funderburk, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baylor University</name>
      <address>
        <city>Waco</city>
        <state>Texas</state>
        <zip>76798</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://greathouselab.github.io/Fiber_Intervention_Study/</url>
    <description>Study analysis</description>
  </link>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>August 13, 2020</last_update_submitted>
  <last_update_submitted_qc>August 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor University</investigator_affiliation>
    <investigator_full_name>Leigh Greathouse</investigator_full_name>
    <investigator_title>Assistant Professor of Nutrition Sciences</investigator_title>
  </responsible_party>
  <keyword>Fiber</keyword>
  <keyword>Microbiome</keyword>
  <keyword>Metabolism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Gain</mesh_term>
    <mesh_term>Body-Weight Trajectory</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share individual data</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/NCT04498455
org study id: 1255329-5
nct id: NCT04498455
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A randomized placebo controlled trial to determine if increased dietary fiber will prevent
      weight gain, inhibit adiposity and reduce perceived stress levels in residents at the Waco
      Family Health Center as the result of changes in distal gut microbiota composition and
      function.
This study will utilize a single blind, placebo controlled, parallel design to assess the
      effect of dietary fiber [Prebiotin] on the gut microbiome, perceived stress, anthropometric
      variables, and clinical biomarkers of metabolism. All participants in this study will be
      resident physicians at the Family Health Center in Waco, TX. This population was selected
      based on pilot data indicating they are at a greater risk for weight gain and have higher
      levels of stress than the average population. The goal is to recruit 40 participants for a 12
      week intervention trial.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized placebo-controlled trial of a fiber supplement [Prebiotin] compared to placebo [maltodextrin]
primary purpose: Prevention
masking: Single (Participant)
measure: Change in body weight
time frame: 12 weeks
description: The investigators will use the following procedure to assess the effect of Prebiotin (OEI) on changes in body weight: there will be two test days: a) baseline (Day 0), prior to randomization to OEI or placebo; and b) week 12, following the 11 week course of OEI/placebo treatment. The investigators will use OEI for the inulin challenge. Change in body weight will be quantified by bio electrical impedance.
arm group label: Placebo
arm group type: Placebo Comparator
description: Dietary Supplement: Placebo
arm group label: Prebiotin
arm group type: Active Comparator
description: Dietary Supplement: Prebiotin (oligofructose enriched inulin)
intervention type: Dietary Supplement
intervention name: Prebiotin
description: Fructo-oligosaccharide dietary supplement powder
arm group label: Placebo
arm group label: Prebiotin
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: LesLee Funderburk, Ph.D.
role: Principal Investigator
affiliation: Baylor University
facility: 
country: United States
url: https://greathouselab.github.io/Fiber_Intervention_Study/
description: Study analysis
responsible party type: Principal Investigator
investigator affiliation: Baylor University
investigator full name: Leigh Greathouse
investigator title: Assistant Professor of Nutrition Sciences
mesh term: Metabolic Syndrome
mesh term: Body Weight
mesh term: Weight Gain
mesh term: Body-Weight Trajectory
sharing ipd: No
ipd description: No plan to share individual data