<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/NCT03785860</url>
  </required_header>
  <id_info>
    <org_study_id>1335956</org_study_id>
    <nct_id>NCT03785860</nct_id>
  </id_info>
  <brief_title>The Effects of Dietary Fiber on the Gut Microbiome and HDL Particles of Human Subjects</brief_title>
  <official_title>The Effects of Dietary Fiber on the Gut Microbiome and HDL Particles of Human Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this project is to conduct a randomized-order, double-blinded cross-over&#xD;
      trial in 20 participants to test the effects of a dietary fiber formulation on gut microbiota&#xD;
      composition and short chain fatty acid production, lipid profiles, glucose sensitivity,&#xD;
      intestinal permeability, overall gut health, and markers of inflammation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 13, 2019</start_date>
  <completion_date type="Actual">December 23, 2019</completion_date>
  <primary_completion_date type="Actual">December 21, 2019</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in gut microbiota</measure>
    <time_frame>One month time frame for dietary fiber to affect the gut microbiota of participants</time_frame>
    <description>Gene sequencing and data analysis will be conducted to explore the change in gut microbial abundance and diversity. Specifically, the primary outcome measure will be change in the proportion of Bifidobacterium, Lactobacillus, and/or Akkermansia muciniphila.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Gut Microbiota</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>On the Placebo arm of the intervention, participants will consume a placebo powder.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dietary Fiber</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>On the Dietary Fiber arm of the intervention, participants will consume a fiber powder.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dietary Fiber</intervention_name>
    <description>Dietary fiber will be given in a powder form to mix with a beverage of one's choice.</description>
    <arm_group_label>Dietary Fiber</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo will be given in a powder form to mix with a beverage of one's choice.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and female adults 18-45 years old&#xD;
&#xD;
          -  BMI: 23.0-32.0 kg/m2 (&quot;overweight&quot;)&#xD;
&#xD;
          -  Current diet includes low quantity of fiber, defined as less than approximately&#xD;
             15g/day, or equivalent to approximately 4 servings of fruit, vegetable, legume, or&#xD;
             whole grain combined per day, and determined using diet recall.&#xD;
&#xD;
          -  Willingness to consume prebiotic fiber drink daily for 4 weeks, and a placebo drink&#xD;
             for 4 weeks, as well as a 4-week washout period with no intervention.&#xD;
&#xD;
          -  Willingness to provide diet records, blood samples and stool samples (self-collected)&#xD;
             biweekly for the duration of the study (7 total collections).&#xD;
&#xD;
          -  Willingness to adhere to &quot;diet control period&quot; biweekly (eating the same,&#xD;
             self-selected foods and abstaining from alcohol each day for 3 days prior to each&#xD;
             stool collection/blood draw).&#xD;
&#xD;
          -  General bowel movement frequency of at least once every three days and maximum of two&#xD;
             times per day.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A plan to or desire to lose weight&#xD;
&#xD;
          -  Smoker&#xD;
&#xD;
          -  Anemia and difficulty with blood draws&#xD;
&#xD;
          -  Currently, within previous 6 weeks of the study, or during the study taken probiotic&#xD;
             or prebiotic formulations (food products considered to have these properties in their&#xD;
             natural or unadulterated forms are acceptable).&#xD;
&#xD;
          -  Antibiotic use during the study or within 6 months prior to study commencement.&#xD;
&#xD;
          -  Medication: statins, blood pressure medications, other prescription medications&#xD;
&#xD;
          -  Pregnant, planning to be pregnant or breast feeding at any point during the study or&#xD;
             study enrollment.&#xD;
&#xD;
          -  Start or change in use of hormonal birth control in the last 6 months or plans to&#xD;
             change or start use of hormonal birth control during the study period&#xD;
&#xD;
          -  Allergies to any prebiotic or placebo ingredients - Prebiotic ingredients: Resistant&#xD;
             Tapioca Starch, Fructooligosaccharide, Sugarcane Fiber, Agave Inulin, Gum Arabic,&#xD;
             Xanthan Gum, Apple Powder, Raspberry Powder, Blueberry Powder / Placebo Blend: Rice&#xD;
             Flour, Xanthan Gum, Grape Powder, Plum Powder&#xD;
&#xD;
          -  Illness (flu/cold in the last two weeks)&#xD;
&#xD;
          -  Documented chronic diseases including diabetes, thyroid disease, metabolic syndrome,&#xD;
             hypertension, cancer, or previous cardiovascular events&#xD;
&#xD;
          -  Irritable bowel syndrome, celiac disease, or any inflammatory bowel disease (including&#xD;
             Crohn's Disease, and/or Ulcerative colitis)&#xD;
&#xD;
          -  Any immunosuppression symptoms at any point during the study or study enrollment&#xD;
&#xD;
          -  Consumption of &gt;1 alcoholic drink/day or frequent binge drinking (&gt;3 alcoholic drinks&#xD;
             in one episode) &gt; 1 day per month&#xD;
&#xD;
          -  Plans to change or recent significant changes in lifestyle (e.g. diet or exercise&#xD;
             routine, major travel, etc)&#xD;
&#xD;
          -  Recent weight fluctuations (greater than 10% in the last six months)&#xD;
&#xD;
          -  Regular use of over-the-counter pain medications (&gt;1/week)&#xD;
&#xD;
          -  Taking prescription lipid medications (e.g. statins) or other supplements known to&#xD;
             alter lipoprotein metabolism such as isoflavones&#xD;
&#xD;
          -  Recent medical procedure such as surgery within the last 6 months&#xD;
&#xD;
          -  Any changes in the above during the course of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California, Davis Department of Nutrition</name>
      <address>
        <city>Davis</city>
        <state>California</state>
        <zip>95616</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>January 7, 2021</last_update_submitted>
  <last_update_submitted_qc>January 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03785860
org study id: 1335956
nct id: NCT03785860
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of this project is to conduct a randomized-order, double-blinded cross-over
      trial in 20 participants to test the effects of a dietary fiber formulation on gut microbiota
      composition and short chain fatty acid production, lipid profiles, glucose sensitivity,
      intestinal permeability, overall gut health, and markers of inflammation.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Change in gut microbiota
time frame: One month time frame for dietary fiber to affect the gut microbiota of participants
description: Gene sequencing and data analysis will be conducted to explore the change in gut microbial abundance and diversity. Specifically, the primary outcome measure will be change in the proportion of Bifidobacterium, Lactobacillus, and/or Akkermansia muciniphila.
arm group label: Placebo
arm group type: Placebo Comparator
description: On the Placebo arm of the intervention, participants will consume a placebo powder.
arm group label: Dietary Fiber
arm group type: Active Comparator
description: On the Dietary Fiber arm of the intervention, participants will consume a fiber powder.
intervention type: Other
intervention name: Dietary Fiber
description: Dietary fiber will be given in a powder form to mix with a beverage of one's choice.
arm group label: Dietary Fiber
intervention type: Other
intervention name: Placebo
description: Placebo will be given in a powder form to mix with a beverage of one's choice.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No