<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/NCT03275662</url>
  </required_header>
  <id_info>
    <org_study_id>36643</org_study_id>
    <nct_id>NCT03275662</nct_id>
  </id_info>
  <brief_title>Fermented and Fiber-rich Food (FeFiFo) Study</brief_title>
  <official_title>Microbiota-targeted Dietary Strategies to Reduce Inflammatory Markers of Americans: High Fiber vs Fermented Food</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</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 primary objective is to contrast the degree to which increased consumption of dietary&#xD;
      fiber vs. fermented food can decrease inflammation, increase microbiota diversity and can&#xD;
      impact microbiota production of short-chain fatty acids (SCFA), potential normalizers of&#xD;
      metabolic and immune dysfunction, in obese and non-obese adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The gut microbiota is central to human health, and the modern, industrialized gut microbiota&#xD;
      has been linked to numerous chronic diseases that are driven by inflammation. It is likely&#xD;
      dietary changes in the last half-century consistent with adoption of the Western diet have&#xD;
      had an adverse impact on the gut microbiota. A critically important next step in this field&#xD;
      of research is to identify how different dietary interventions can potentially restore&#xD;
      healthy features of the gut microbiota in alignment with the optimization of human health.&#xD;
      Dietary interventions that target the microbiota and reduce inflammation may reverse or&#xD;
      prevent chronic diseases including obesity, metabolic syndrome, and inflammatory bowel&#xD;
      disease. This study is designed to elicit and contrast inflammatory markers in blood with the&#xD;
      amount of increase in microbiota diversity and related metabolic output achievable by two&#xD;
      dietary approaches commonly available to the general population. The results could contribute&#xD;
      to dietary recommendations for reversing the chronic disease epidemics of Westernization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 29, 2016</start_date>
  <completion_date type="Actual">June 2, 2017</completion_date>
  <primary_completion_date type="Actual">June 2, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Immune profile: Cytokine Response Score (CRS)</measure>
    <time_frame>Baseline and 10 weeks</time_frame>
    <description>Change from baseline in CRS at 10 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Microbiota metabolites: short-chain fatty acids (SCFA)</measure>
    <time_frame>Baseline and 10 weeks</time_frame>
    <description>Change from baseline in short-chain fatty acids (SCFA) at 10 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microbiota composition</measure>
    <time_frame>Baseline and 10 weeks</time_frame>
    <description>Change from baseline in 16S rRNA enumeration at 10 weeks, determined using Illumina-based sequencing.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Metabolic Syndrome</condition>
  <condition>Microbiome</condition>
  <condition>Immune Function</condition>
  <condition>Inflammation</condition>
  <arm_group>
    <arm_group_label>Fiber Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are asked to increase their usual dietary fiber intake by 20 grams/day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fermented Foods Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are asked to consume 6 servings of fermented foods per day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dietary Fiber</intervention_name>
    <arm_group_label>Fiber Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Fermented Foods</intervention_name>
    <arm_group_label>Fermented Foods Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 and older, both genders, all ethnic backgrounds&#xD;
&#xD;
          -  Healthy subjects willing and able to provide blood, as well as stool specimens&#xD;
&#xD;
          -  Able to provide signed and dated informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index higher than 40.&#xD;
&#xD;
          -  Vital signs outside of acceptable range at Screening Visit, i.e., blood pressure&#xD;
             greater than 160/100, oral temperature greater than 100 degrees F, pulse greater than&#xD;
             100.&#xD;
&#xD;
          -  Use of any of the following drugs within the last 6 months:&#xD;
&#xD;
               1. systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous,&#xD;
                  intramuscular, or oral);&#xD;
&#xD;
               2. oral, intravenous, intramuscular, nasal or inhaled corticosteroids;&#xD;
&#xD;
               3. cytokines;&#xD;
&#xD;
               4. methotrexate or immunosuppressive cytotoxic agents;&#xD;
&#xD;
               5. large doses of commercial probiotics consumed (greater than or equal to 10e8 cfu&#xD;
                  or organisms per day) - includes tablets, capsules, lozenges, chewing gum or&#xD;
                  powders in which probiotic is a primary component.&#xD;
&#xD;
               6. consumption of &gt; 20 g fiber/day and &gt; 7 servings of fermented foods per week.&#xD;
&#xD;
          -  Acute disease at the time of enrollment (defer sampling until subject recovers). Acute&#xD;
             disease is defined as the presence of a moderate or severe illness with or without&#xD;
             fever.&#xD;
&#xD;
          -  Chronic, clinically significant (unresolved, requiring on-going medical management or&#xD;
             medication) pulmonary, cardiovascular, gastrointestinal, hepatic or renal functional&#xD;
             abnormality, as determined by medical history or physical examination.&#xD;
&#xD;
          -  History of cancer except for squamous or basal cell carcinomas of the skin that have&#xD;
             been medically managed by local excision.&#xD;
&#xD;
          -  Unstable dietary history as defined by major changes in diet during the previous&#xD;
             month, where the subject has eliminated or significantly increased a major food group&#xD;
             in the diet.&#xD;
&#xD;
          -  Recent history of chronic alcohol consumption defined as more than five 1.5-ounce&#xD;
             servings of 80 proof distilled spirits, five 12-ounce servings of beer or five 5-ounce&#xD;
             servings of wine per day.&#xD;
&#xD;
          -  Positive test for HIV, HBV or HCV.&#xD;
&#xD;
          -  Any confirmed or suspected condition/state of immunosuppression or immunodeficiency (&#xD;
             primary or acquired) including HIV infection.&#xD;
&#xD;
          -  Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy,&#xD;
             in the past five years. Any major bowel resection at any time.&#xD;
&#xD;
          -  History of active uncontrolled gastrointestinal disorders or diseases including:&#xD;
&#xD;
               1. inflammatory bowel disease (IBD) including ulcerative colitis&#xD;
                  (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate&#xD;
                  colitis;&#xD;
&#xD;
               2. irritable bowel syndrome (IBS) (moderate-severe);&#xD;
&#xD;
               3. persistent, infectious gastroenteritis, colitis or gastritis, persistent or&#xD;
                  chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent)&#xD;
                  or Helicobacter pylori infection (untreated);&#xD;
&#xD;
               4. chronic constipation.&#xD;
&#xD;
        Female who is pregnant or lactating.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Justin L Sonnenburg, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christopher D Gardner, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University School of Medicine</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://med.stanford.edu/nutrition/research/completed-studies/fefifo.html</url>
    <description>Study description and results summary</description>
  </link>
  <reference>
    <citation>Wastyk HC, Fragiadakis GK, Perelman D, Dahan D, Merrill BD, Yu FB, Topf M, Gonzalez CG, Van Treuren W, Han S, Robinson JL, Elias JE, Sonnenburg ED, Gardner CD, Sonnenburg JL. Gut-microbiota-targeted diets modulate human immune status. Cell. 2021 Aug 5;184(16):4137-4153.e14. doi: 10.1016/j.cell.2021.06.019. Epub 2021 Jul 12.</citation>
    <PMID>34256014</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>February 22, 2023</last_update_submitted>
  <last_update_submitted_qc>February 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Justin L. Sonnenburg</investigator_full_name>
    <investigator_title>Associate Professor of Microbiology and Immunology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <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/NCT03275662
org study id: 36643
nct id: NCT03275662
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The primary objective is to contrast the degree to which increased consumption of dietary
      fiber vs. fermented food can decrease inflammation, increase microbiota diversity and can
      impact microbiota production of short-chain fatty acids (SCFA), potential normalizers of
      metabolic and immune dysfunction, in obese and non-obese adults.
The gut microbiota is central to human health, and the modern, industrialized gut microbiota
      has been linked to numerous chronic diseases that are driven by inflammation. It is likely
      dietary changes in the last half-century consistent with adoption of the Western diet have
      had an adverse impact on the gut microbiota. A critically important next step in this field
      of research is to identify how different dietary interventions can potentially restore
      healthy features of the gut microbiota in alignment with the optimization of human health.
      Dietary interventions that target the microbiota and reduce inflammation may reverse or
      prevent chronic diseases including obesity, metabolic syndrome, and inflammatory bowel
      disease. This study is designed to elicit and contrast inflammatory markers in blood with the
      amount of increase in microbiota diversity and related metabolic output achievable by two
      dietary approaches commonly available to the general population. The results could contribute
      to dietary recommendations for reversing the chronic disease epidemics of Westernization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Immune profile: Cytokine Response Score (CRS)
time frame: Baseline and 10 weeks
description: Change from baseline in CRS at 10 weeks
measure: Microbiota metabolites: short-chain fatty acids (SCFA)
time frame: Baseline and 10 weeks
description: Change from baseline in short-chain fatty acids (SCFA) at 10 weeks.
measure: Microbiota composition
time frame: Baseline and 10 weeks
description: Change from baseline in 16S rRNA enumeration at 10 weeks, determined using Illumina-based sequencing.
arm group label: Fiber Group
arm group type: Experimental
description: Participants are asked to increase their usual dietary fiber intake by 20 grams/day.
arm group label: Fermented Foods Group
arm group type: Experimental
description: Participants are asked to consume 6 servings of fermented foods per day.
intervention type: Behavioral
intervention name: Dietary Fiber
arm group label: Fiber Group
intervention type: Behavioral
intervention name: Fermented Foods
arm group label: Fermented Foods Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Justin L Sonnenburg, PhD
role: Principal Investigator
affiliation: Stanford University
last name: Christopher D Gardner, PhD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
url: https://med.stanford.edu/nutrition/research/completed-studies/fefifo.html
description: Study description and results summary
citation: Wastyk HC, Fragiadakis GK, Perelman D, Dahan D, Merrill BD, Yu FB, Topf M, Gonzalez CG, Van Treuren W, Han S, Robinson JL, Elias JE, Sonnenburg ED, Gardner CD, Sonnenburg JL. Gut-microbiota-targeted diets modulate human immune status. Cell. 2021 Aug 5;184(16):4137-4153.e14. doi: 10.1016/j.cell.2021.06.019. Epub 2021 Jul 12.
PMID: 34256014
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Justin L. Sonnenburg
investigator title: Associate Professor of Microbiology and Immunology
mesh term: Metabolic Syndrome
mesh term: Inflammation
sharing ipd: No