<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/NCT03016065</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201602266</org_study_id>
    <nct_id>NCT03016065</nct_id>
  </id_info>
  <brief_title>Efficacy of Pea Hull Fiber - Phase 2</brief_title>
  <official_title>Efficacy of Pea Hull Fiber Supplementation on Gastrointestinal Transit in Overweight Children.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Saskatchewan Pulse Growers</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</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 purpose of this randomized, cross-over study is to explore the effects of pea hull fiber&#xD;
      on bowel movement frequency, transit time, appetite, gastrointestinal symptoms, microbiota&#xD;
      composition and activity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An 8-week randomized, cross-over study will be carried out to assess the efficacy of pea hull&#xD;
      fiber. Participants will complete a 2-week baseline period during which appetite, stool&#xD;
      frequency, and stool consistency (transit time) will be collected by an online questionnaire,&#xD;
      and participants will collect a single stool. Dietary data (Automated Self-Administered&#xD;
      24-Hour diet recall) will be obtained at baseline and at each study visit. Participants will&#xD;
      be randomized on or about day 15 and consume snacks without pea hull fiber for a 2-week&#xD;
      control period, and snacks with added pea hull fiber for a 2-week treatment period separated&#xD;
      by a 2-week washout period. In both intervention periods, participants will complete daily&#xD;
      questionnaires to assess stool frequency and consistency (transit time). An online&#xD;
      questionnaire assessing appetite will be administered once per week. The GSRS will be&#xD;
      competed at each study visit. During washout periods, the same data will be collected as will&#xD;
      be done during the baseline and intervention periods. Participants will be asked to collect&#xD;
      one stool during baseline and during weeks 4, 6, and 8 for a total of 4 stools. Stool samples&#xD;
      will be analyzed for changes in the microbiota.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 29, 2017</start_date>
  <completion_date type="Actual">November 15, 2022</completion_date>
  <primary_completion_date type="Actual">December 15, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Modified Bristol Stool Form score</measure>
    <time_frame>Change from baseline at weeks 4, 6 and 8</time_frame>
    <description>Stool consistency rating by Modified Bristol Stool Form for children</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in number of bowel movements per week</measure>
    <time_frame>Change from baseline at weeks 4, 6 and 8</time_frame>
    <description>Stool frequency per week</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Pea Fiber</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Snacks fortified with 10 g of pea hull fiber will be administered for two weeks, followed by a two-week washout, and a two-week period with control snacks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control snacks will provided for 2 weeks, followed by a two-week washout, and snacks with 10 g/d of pea fiber for 2 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Pea Fiber</intervention_name>
    <description>Baked goods (2 snacks) with fiber-fortified with 5 g/snack of ground pea hulls</description>
    <arm_group_label>Pea Fiber</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Baked goods (2 snacks) without added fiber</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Are willing to have height and weight measured and provide demographic information&#xD;
             (e.g. age, race, sex).&#xD;
&#xD;
          -  Children age between 8-15 years old.&#xD;
&#xD;
          -  Are occasionally constipated.&#xD;
&#xD;
          -  Are willing to consume pea hull fiber and control snacks daily each for a 2-week&#xD;
             period&#xD;
&#xD;
          -  Are willing to complete a daily questionnaire throughout the entire 8-week study.&#xD;
&#xD;
          -  Are willing to complete the appetite questionnaire two times per week.&#xD;
&#xD;
          -  Are willing to complete the Gastrointestinal Symptom Rating Scale (GSRS) bi-weekly.&#xD;
&#xD;
          -  Are willing to be interviewed for Automated Self-Administered 24-Hour-Kids-2014&#xD;
             (ASA24-Kids-2014) one time per 2-week period throughout the study.&#xD;
&#xD;
          -  Are willing and be able to provide a valid social security for study payment purposes.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Have any known food allergies.&#xD;
&#xD;
          -  Are currently taking medications for diarrhea.&#xD;
&#xD;
          -  Have taken antibiotics within the past four weeks prior to randomization.&#xD;
&#xD;
          -  Have ≥ 6 bowel movements per week&#xD;
&#xD;
          -  Are currently taking probiotics supplements and do not want to discontinue a minimum&#xD;
             of two weeks prior to the study.&#xD;
&#xD;
          -  Have previously or are currently being treated for any gastrointestinal diseases such&#xD;
             as (gastric ulcers, Crohn's, Celiac, ulcerative colitis, etc.).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wendy J Dahl, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida, Food Science and Human Nutrition Dept</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>November 28, 2022</last_update_submitted>
  <last_update_submitted_qc>November 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2022</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/NCT03016065
org study id: IRB201602266
nct id: NCT03016065
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this randomized, cross-over study is to explore the effects of pea hull fiber
      on bowel movement frequency, transit time, appetite, gastrointestinal symptoms, microbiota
      composition and activity.
An 8-week randomized, cross-over study will be carried out to assess the efficacy of pea hull
      fiber. Participants will complete a 2-week baseline period during which appetite, stool
      frequency, and stool consistency (transit time) will be collected by an online questionnaire,
      and participants will collect a single stool. Dietary data (Automated Self-Administered
      24-Hour diet recall) will be obtained at baseline and at each study visit. Participants will
      be randomized on or about day 15 and consume snacks without pea hull fiber for a 2-week
      control period, and snacks with added pea hull fiber for a 2-week treatment period separated
      by a 2-week washout period. In both intervention periods, participants will complete daily
      questionnaires to assess stool frequency and consistency (transit time). An online
      questionnaire assessing appetite will be administered once per week. The GSRS will be
      competed at each study visit. During washout periods, the same data will be collected as will
      be done during the baseline and intervention periods. Participants will be asked to collect
      one stool during baseline and during weeks 4, 6, and 8 for a total of 4 stools. Stool samples
      will be analyzed for changes in the microbiota.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Modified Bristol Stool Form score
time frame: Change from baseline at weeks 4, 6 and 8
description: Stool consistency rating by Modified Bristol Stool Form for children
measure: Change in number of bowel movements per week
time frame: Change from baseline at weeks 4, 6 and 8
description: Stool frequency per week
arm group label: Pea Fiber
arm group type: Experimental
description: Snacks fortified with 10 g of pea hull fiber will be administered for two weeks, followed by a two-week washout, and a two-week period with control snacks.
arm group label: Control
arm group type: Placebo Comparator
description: Control snacks will provided for 2 weeks, followed by a two-week washout, and snacks with 10 g/d of pea fiber for 2 weeks.
intervention type: Dietary Supplement
intervention name: Pea Fiber
description: Baked goods (2 snacks) with fiber-fortified with 5 g/snack of ground pea hulls
arm group label: Pea Fiber
intervention type: Dietary Supplement
intervention name: Control
description: Baked goods (2 snacks) without added fiber
arm group label: Control
criteria: 
gender: All
minimum age: 8 Years
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Wendy J Dahl, PhD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No