xml: <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/NCT06023940</url>
    </required_header>
    <id_info>
      <org_study_id>2053546</org_study_id>
      <nct_id>NCT06023940</nct_id>
    </id_info>
    <brief_title>Variability in Microbial Response to Dietary Fiber</brief_title>
    <acronym>TRIUMPH</acronym>
    <official_title>Variability in Microbial Response to Dietary Fiber</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Missouri-Columbia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Missouri-Columbia</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>
        The goal of this clinical trial is to understand varying in responses to different dietary&#xD;
        patterns in healthy people who are getting a health screening colonoscopy.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  What is the variability in the change of the microbes in the gut of (1) a provided diet&#xD;
             that is high in fiber vs (2) a diet of the participant's choice.&#xD;
  &#xD;
          -  What is the magnitude of fasting changes in glucose and lipids following the short-term,&#xD;
             high-fiber feeding period and identify candidate predictive factors (short-chain fatty&#xD;
             acids, BMI, sex, starting glucose level) for these changes&#xD;
  &#xD;
        Participants will be in one of two groups:&#xD;
  &#xD;
          1. High-fiber diet group: These participants will have a series of measurements that&#xD;
             include: blood biochemistries, body composition measured via DEXA, anthropometrics,&#xD;
             surveys and questionnaires, and collection of fecal samples.&#xD;
  &#xD;
          2. Normal diet group: These participants will eat a diet that is of their choosing (ad&#xD;
             libitum) and will have a series of measurements that include: fecal samples, and&#xD;
             questionnaires/surveys including food records.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Fiber fermentation in the colon produces short chain fatty acids (SCFA) and alters the&#xD;
        microbial composition and activity. These effects may be mechanisms linking a high-fiber diet&#xD;
        to improved health. However, different people may respond to dietary fiber differently and&#xD;
        the variability in early, dietary-induced SCFA concentration changes has not been&#xD;
        established. This lack of basic understanding in individual patterns of microbial SCFA&#xD;
        production significantly limits efforts in the field of Precision Nutrition designed to&#xD;
        target dietary strategies to improve health and advance lifestyle treatments in healthcare in&#xD;
        the future. In this project, the central hypothesis is that the mechanisms by which dietary&#xD;
        fiber provide metabolic benefits include a direct physical effect to improve fasting glucose&#xD;
        and lipids and an effect related to increasing SCFA concentration. These are the ideas being&#xD;
        tested in this study.&#xD;
  &#xD;
        Using fiber derived from peas in a two-week human feeding intervention, Aim 1 will quantitate&#xD;
        the variability in high-fiber-induced change in microbial composition and SCFA production by&#xD;
        specifically testing the hypothesis that Following successful colonoscopy bowel prep,&#xD;
        variability in the reduction in microbial species will be very small, while repopulation&#xD;
        after a standardized high-fiber diet will be characterized by larger differences between&#xD;
        individuals with regard to the quantity of bifidobacterial and the Firmicutes/ Bacteroidetes&#xD;
        ratio.&#xD;
  &#xD;
        Aim 2 will quantitate the magnitude of fasting changes in glucose and lipids following the&#xD;
        short-term, high-fiber feeding period and identify candidate predictive factors (SCFA, BMI,&#xD;
        sex, starting glucose level) for these changes by testing the hypothesis that a two-week,&#xD;
        high-fiber diet will result in lower plasma glycemia and triglycerides. Participants (n=30)&#xD;
        who have undergone a health-screening colonoscopy (HSC) are fed a high-fiber diet for 14&#xD;
        days. Fecal samples are collected before the colonoscopy and on days 1, 7 and 14 after the&#xD;
        colonoscopy during high-fiber feeding. On day 1 and 14, the subject visits the clinical unit&#xD;
        for a fasting blood draw (for measurement of glucose, lipids, and plasma SCFA), surveys and&#xD;
        questionnaires.&#xD;
  &#xD;
        A control arm will also be included as part of this study. The purpose of the control arm is&#xD;
        to quantitate the variability in microbial composition and SCFA production from an ad libitum&#xD;
        diet of participants. Instead of providing a high-fiber diet, the repopulation of the gut&#xD;
        microbiome will be observed when participants eat a diet that is of their choosing. A series&#xD;
        of food records and fecal samples pre- and post-procedure will be collected. Figure 2 shows&#xD;
        the protocol of this arm. Food records will be collected: pre-procedure, days 0 (procedure&#xD;
        day), 1, 2, 4, 7, 10, 13. Fecal collection will be collected: pre-procedure, 3, 5, 8, 11, 14.&#xD;
        This arm will not include the blood collection or DEXA scan.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 12, 2022</start_date>
    <completion_date type="Anticipated">April 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2024</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>
      <intervention_model_description>Treatment group: 2 week high fiber diet Control group: no diet provided, subjects eat whatever they want</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Variability in microbial composition as measured by 'alpha diversity'</measure>
      <time_frame>2 weeks</time_frame>
      <description>Measured via fecal sample. Intervention group - measured once before scheduled health screening colonoscopy and 2 times over 2 weeks post-colonoscopy (day 1, 7, 14).&#xD;
  Control group - measured once before scheduled health screening colonoscopy and 5 days over 2 weeks post-colonoscopy (day 3, 5, 8, 11, 14).&#xD;
  Variability in microbial composition refers to how many different kinds of microbes are present in the fecal sample. We are testing the possibility that the more kinds of microbes, the healthier the person. The higher the measure the alpha diversity, the greater the number of different microbes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Concentration of SCFA</measure>
      <time_frame>2 weeks</time_frame>
      <description>Measured via fecal sample. Intervention group - measured once before scheduled health screening colonoscopy and 2 times over 2 weeks post-colonoscopy (day 1, 7, 14).&#xD;
  Control group - measured once before scheduled health screening colonoscopy and 5 days over 2 weeks post-colonoscopy (day 3, 5, 8, 11, 14).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Blood glucose concentration (mg/dL)</measure>
      <time_frame>2 weeks</time_frame>
      <description>Measure changes in fasting blood glucose concentration following the short-term, high-fiber feeding period. Blood taken at screening, baseline, and follow up.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood lipid concentration (mg/dL)</measure>
      <time_frame>2 weeks</time_frame>
      <description>Measure changes in fasting blood lipid concentration (mg/dL) following the short-term, high-fiber feeding period. Blood taken at screening, baseline, and follow up.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Microbial Colonization</condition>
    <arm_group>
      <arm_group_label>High Fiber</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects are provided a high-fiber diet for 2 weeks. Tests include: blood biochemistries, body composition measured via DEXA, fecal sample collection, and anthropometrics measured</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Subjects are not provided any diet, instead they eat what they choose for two weeks while they participate in a series of tests including: fecal sampling, food records, questionnaires/surveys, and anthropometrics</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>High fiber</intervention_name>
      <description>A pea fiber supplement is added to a diet of regular foods. Participants receive 25g fiber daily.</description>
      <arm_group_label>High Fiber</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Intervention Arm&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  Men and women&#xD;
  &#xD;
            -  Age 45-65y: the average age of people referred for a screening colonoscopy&#xD;
  &#xD;
            -  BMI ≥20.0 or ≤40.0 kg/m2&#xD;
  &#xD;
            -  Weight stable: no fluctuations in body weight of greater than 4 kg in the last 3&#xD;
               months&#xD;
  &#xD;
            -  Scheduled for a health-screening colonoscopy&#xD;
  &#xD;
            -  Willingness to consume a high-fiber diet&#xD;
  &#xD;
            -  Willing to provide blood and fecal samples&#xD;
  &#xD;
            -  Healthy or have one or more characteristics of the metabolic syndrome (but not&#xD;
               diabetic) Metabolic syndrome criteria&#xD;
  &#xD;
                 1. A large waistline: 35 inches or more for women 40 inches or more for men&#xD;
  &#xD;
                 2. High triglycerides: 150 mg/dL or higher&#xD;
  &#xD;
                 3. Low HDLc level: &lt;50 mg/dL for women &lt;40 mg/dL for men&#xD;
  &#xD;
                 4. High blood pressure ≥130/85 mmHg&#xD;
  &#xD;
                 5. Fasting blood sugar ≥100 mg/dL - Pre-diabetes acceptable (glucose &lt;125 mg/dL or&#xD;
                    HbA1c &lt;6.5%)&#xD;
  &#xD;
            -  Subjects are also eligible if they are stably treated with statin drugs,&#xD;
               anti-hypertensive medications, and anti-depressants. These are eligible as long as the&#xD;
               drug category does not alter appetite, body weight, or the microbiome (if known).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant or lactating, or planning to become pregnant&#xD;
  &#xD;
            -  BMI of &lt;20.0 or &gt;40.0 kg/m2&#xD;
  &#xD;
            -  Use of tobacco products&#xD;
  &#xD;
            -  Uncontrolled hypertension and blood pressure ≥ 180/110&#xD;
  &#xD;
            -  Use of medications that affect the gut microbiome (e.g., antibiotics)&#xD;
  &#xD;
            -  Taking medications known to affect appetite (phentermine) or gastrointestinal function&#xD;
               (e.g. metformin)&#xD;
  &#xD;
            -  On a special diet vegetarian, or other restricted dietary patterns&#xD;
  &#xD;
            -  Undergoing weight loss&#xD;
  &#xD;
            -  Ad libitum intake of fiber above 25 g/day (mean intake in the US population is 17&#xD;
               g/day) and also an intake of fiber &lt;10 g/d&#xD;
  &#xD;
            -  Ad libitum alcohol intake of greater than 7 drinks/week for women and 14 drinks/week&#xD;
               for men&#xD;
  &#xD;
            -  History of disease (example colon cancer, etc.)&#xD;
  &#xD;
            -  Live more than 45 miles away from the University because participants will need to&#xD;
               come into the Lab every 3 days or so to pick up meals.&#xD;
  &#xD;
          Control Arm Inclusion criteria&#xD;
  &#xD;
            -  Men and women&#xD;
  &#xD;
            -  Age 45-65y: the average age of people referred for a screening colonoscopy&#xD;
  &#xD;
            -  Scheduled for a health-screening colonoscopy&#xD;
  &#xD;
            -  Willing to provide fecal samples&#xD;
  &#xD;
            -  Subjects are also eligible if they are stably treated with statin drugs,&#xD;
               anti-hypertensive medications, and anti-depressants. These are eligible as long as the&#xD;
               drug category does not alter appetite, body weight, or the microbiome (if known).&#xD;
  &#xD;
          Exclusion criteria&#xD;
  &#xD;
            -  Pregnant or lactating, or planning to become pregnant&#xD;
  &#xD;
            -  Use of medications that affect the gut microbiome (e.g., antibiotics within the past&#xD;
               30 days)&#xD;
  &#xD;
            -  History of disease (example colon cancer, active GI bleeding, inflammatory bowel&#xD;
               disease, etc.)&#xD;
  &#xD;
            -  Live more than 45 miles away from the University because participants will need to&#xD;
               come into the Lab every 3 days or so to deliver fecal samples.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Elizabeth Parks</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Missouri-Columbia</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Yezaz Ghouri, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Missouri-Columbia</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Katherene Anguah, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Missouri-Columbia</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Katherene Anguah, PhD</last_name>
      <phone>(573) 882-8966</phone>
      <email>anguahk@missouri.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Elizabeth Parks, PhD</last_name>
      <phone>(573) 882-5864</phone>
      <email>parksej@missouri.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Missouri</name>
        <address>
          <city>Columbia</city>
          <state>Missouri</state>
          <zip>65212</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Katherene Anguah, PhD</last_name>
        <phone>573-882-8966</phone>
        <email>anguahk@umsystem.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Missouri-Columbia</investigator_affiliation>
      <investigator_full_name>Elizabeth Parks</investigator_full_name>
      <investigator_title>Professor, Nutrition &amp; Exercise Physiology-MED</investigator_title>
    </responsible_party>
    <keyword>colonoscopy</keyword>
    <keyword>fiber</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Infections</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06023940
  org study id: 2053546
  nct id: NCT06023940
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to understand varying in responses to different dietary
        patterns in healthy people who are getting a health screening colonoscopy.
  
        The main questions it aims to answer are:
  
          -  What is the variability in the change of the microbes in the gut of (1) a provided diet
             that is high in fiber vs (2) a diet of the participant's choice.
  
          -  What is the magnitude of fasting changes in glucose and lipids following the short-term,
             high-fiber feeding period and identify candidate predictive factors (short-chain fatty
             acids, BMI, sex, starting glucose level) for these changes
  
        Participants will be in one of two groups:
  
          1. High-fiber diet group: These participants will have a series of measurements that
             include: blood biochemistries, body composition measured via DEXA, anthropometrics,
             surveys and questionnaires, and collection of fecal samples.
  
          2. Normal diet group: These participants will eat a diet that is of their choosing (ad
             libitum) and will have a series of measurements that include: fecal samples, and
             questionnaires/surveys including food records.
  Fiber fermentation in the colon produces short chain fatty acids (SCFA) and alters the
        microbial composition and activity. These effects may be mechanisms linking a high-fiber diet
        to improved health. However, different people may respond to dietary fiber differently and
        the variability in early, dietary-induced SCFA concentration changes has not been
        established. This lack of basic understanding in individual patterns of microbial SCFA
        production significantly limits efforts in the field of Precision Nutrition designed to
        target dietary strategies to improve health and advance lifestyle treatments in healthcare in
        the future. In this project, the central hypothesis is that the mechanisms by which dietary
        fiber provide metabolic benefits include a direct physical effect to improve fasting glucose
        and lipids and an effect related to increasing SCFA concentration. These are the ideas being
        tested in this study.
  
        Using fiber derived from peas in a two-week human feeding intervention, Aim 1 will quantitate
        the variability in high-fiber-induced change in microbial composition and SCFA production by
        specifically testing the hypothesis that Following successful colonoscopy bowel prep,
        variability in the reduction in microbial species will be very small, while repopulation
        after a standardized high-fiber diet will be characterized by larger differences between
        individuals with regard to the quantity of bifidobacterial and the Firmicutes/ Bacteroidetes
        ratio.
  
        Aim 2 will quantitate the magnitude of fasting changes in glucose and lipids following the
        short-term, high-fiber feeding period and identify candidate predictive factors (SCFA, BMI,
        sex, starting glucose level) for these changes by testing the hypothesis that a two-week,
        high-fiber diet will result in lower plasma glycemia and triglycerides. Participants (n=30)
        who have undergone a health-screening colonoscopy (HSC) are fed a high-fiber diet for 14
        days. Fecal samples are collected before the colonoscopy and on days 1, 7 and 14 after the
        colonoscopy during high-fiber feeding. On day 1 and 14, the subject visits the clinical unit
        for a fasting blood draw (for measurement of glucose, lipids, and plasma SCFA), surveys and
        questionnaires.
  
        A control arm will also be included as part of this study. The purpose of the control arm is
        to quantitate the variability in microbial composition and SCFA production from an ad libitum
        diet of participants. Instead of providing a high-fiber diet, the repopulation of the gut
        microbiome will be observed when participants eat a diet that is of their choosing. A series
        of food records and fecal samples pre- and post-procedure will be collected. Figure 2 shows
        the protocol of this arm. Food records will be collected: pre-procedure, days 0 (procedure
        day), 1, 2, 4, 7, 10, 13. Fecal collection will be collected: pre-procedure, 3, 5, 8, 11, 14.
        This arm will not include the blood collection or DEXA scan.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: Treatment group: 2 week high fiber diet Control group: no diet provided, subjects eat whatever they want
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Variability in microbial composition as measured by 'alpha diversity'
  time frame: 2 weeks
  description: Measured via fecal sample. Intervention group - measured once before scheduled health screening colonoscopy and 2 times over 2 weeks post-colonoscopy (day 1, 7, 14).
  Control group - measured once before scheduled health screening colonoscopy and 5 days over 2 weeks post-colonoscopy (day 3, 5, 8, 11, 14).
  Variability in microbial composition refers to how many different kinds of microbes are present in the fecal sample. We are testing the possibility that the more kinds of microbes, the healthier the person. The higher the measure the alpha diversity, the greater the number of different microbes.
  measure: Concentration of SCFA
  time frame: 2 weeks
  description: Measured via fecal sample. Intervention group - measured once before scheduled health screening colonoscopy and 2 times over 2 weeks post-colonoscopy (day 1, 7, 14).
  Control group - measured once before scheduled health screening colonoscopy and 5 days over 2 weeks post-colonoscopy (day 3, 5, 8, 11, 14).
  measure: Blood glucose concentration (mg/dL)
  time frame: 2 weeks
  description: Measure changes in fasting blood glucose concentration following the short-term, high-fiber feeding period. Blood taken at screening, baseline, and follow up.
  measure: Blood lipid concentration (mg/dL)
  time frame: 2 weeks
  description: Measure changes in fasting blood lipid concentration (mg/dL) following the short-term, high-fiber feeding period. Blood taken at screening, baseline, and follow up.
  arm group label: High Fiber
  arm group type: Experimental
  description: Subjects are provided a high-fiber diet for 2 weeks. Tests include: blood biochemistries, body composition measured via DEXA, fecal sample collection, and anthropometrics measured
  arm group label: Control
  arm group type: No Intervention
  description: Subjects are not provided any diet, instead they eat what they choose for two weeks while they participate in a series of tests including: fecal sampling, food records, questionnaires/surveys, and anthropometrics
  intervention type: Dietary Supplement
  intervention name: High fiber
  description: A pea fiber supplement is added to a diet of regular foods. Participants receive 25g fiber daily.
  arm group label: High Fiber
  criteria: 
  gender: All
  minimum age: 45 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Elizabeth Parks
  role: Principal Investigator
  affiliation: University of Missouri-Columbia
  last name: Yezaz Ghouri, MD
  role: Principal Investigator
  affiliation: University of Missouri-Columbia
  last name: Katherene Anguah, PhD
  role: Principal Investigator
  affiliation: University of Missouri-Columbia
  last name: Katherene Anguah, PhD
  phone: (573) 882-8966
  email: anguahk@missouri.edu
  last name: Elizabeth Parks, PhD
  phone: (573) 882-5864
  email: parksej@missouri.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Missouri-Columbia
  investigator full name: Elizabeth Parks
  investigator title: Professor, Nutrition & Exercise Physiology-MED
  mesh term: Communicable Diseases
  mesh term: Infections
  sharing ipd: No