<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/NCT03749031</url>
  </required_header>
  <id_info>
    <org_study_id>PEP-1805</org_study_id>
    <nct_id>NCT03749031</nct_id>
  </id_info>
  <brief_title>Effects of Beverages Containing Orange or Apple Pomace on Digestive Health in Adults</brief_title>
  <official_title>The Effect of Orange or Apple Pomace on Digestive Health in Adults: a Randomized, Double Blind, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PepsiCo Global R&amp;D</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PepsiCo Global R&amp;D</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>
      This is a randomized crossover intervention designed to evaluate effects of daily intake of&#xD;
      beverages containing orange or apple Pomace on gastrointestinal function as measured by stool&#xD;
      frequency. Additional outcomes will include aspects of digestive health and self-reported GI&#xD;
      symptoms and dietary intake as well as analysis of gut microbiota.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2018</start_date>
  <completion_date type="Actual">August 30, 2019</completion_date>
  <primary_completion_date type="Actual">August 30, 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>stool frequency</measure>
    <time_frame>Changes over 7 weeks (daily during 4 week treatment followed by daily during 3 week washout) compared to baseline (daily during 2 week run-in)</time_frame>
    <description>Bowel habits daily diary as weekly averages. Fewer days with no stool, and higher number of stools per week would be better.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-reported GI symptoms</measure>
    <time_frame>Changes over 7 weeks (daily during 4 week treatment followed by daily during 3 week washout) compared to baseline (daily during 2 week run-in)</time_frame>
    <description>GI Tolerability questionnaire, 4 selections. The minimum value is Less than usual. The maximum value is Much more than usual. Pomace treament arms expected to have more GI symptoms than juice arms. Less symptoms are better than more.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stool consistency</measure>
    <time_frame>Changes over 7 weeks (daily during 4 week treatment followed by daily during 3 week washout) compared to baseline (daily during 2 week run-in)</time_frame>
    <description>Bristol score, 7 types of stool drawings presented in a chart from lumpy Type 1, to watery Type 7. Improved consistency would be better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ease of stool passage</measure>
    <time_frame>Changes over 7 weeks (daily during 4 week treatment followed by daily during 3 week washout) compared to baseline (daily during 2 week run-in)</time_frame>
    <description>Rating scale 1 (Very easy) to 5 (Very difficult). Easier passage would be better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>microbiota changes</measure>
    <time_frame>Changes from baseline sample to end of treatment sample (Week 4) and end of 3 week washout sample (Week 7)</time_frame>
    <description>Stool samples for possible explanations of mechanisms of pomace. Higher bacteria associated with fiber fermentation would be better. Species examined include F. Prau, lachnospiraceae, ruminoucoccaceae, bifidobacteria, and changes in alpha and beta diversity as measured by 16S RNA sequencing. Data pending, unknown units at this time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary analysis</measure>
    <time_frame>Changes from 2 week run in (baseline) to the last week of treatment (Week 4) and the last week of 3 week washout (Week 7)</time_frame>
    <description>3-day diet record. Expecting higher daily fiber intake for pomace arms.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Digestive Health</condition>
  <arm_group>
    <arm_group_label>Orange juice only</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>16 oz. orange juice per day for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>orange juice + orange Pomace</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>16 oz. orange juice + orange Pomace per day for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Apple juice only</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>16 oz. apple juice per day for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Apple Juice + Apple Pomace</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>16 oz. apple juice + apple Pomace per day for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Orange juice + Orange Pomace</intervention_name>
    <description>16 oz. orange juice + orange Pomace per day for 4 weeks</description>
    <arm_group_label>orange juice + orange Pomace</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Orange Juice</intervention_name>
    <description>16 oz. orange juice per day for 4 weeks</description>
    <arm_group_label>Orange juice only</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Apple Juice and Apple Pomace</intervention_name>
    <description>16 oz. apple juice and apple Pomace per day for 4 weeks</description>
    <arm_group_label>Apple Juice + Apple Pomace</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Apple Juice</intervention_name>
    <description>16 oz. apple juice per day for 4 weeks</description>
    <arm_group_label>Apple juice only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males and females 18-60 years old&#xD;
&#xD;
          -  Willing and able to consume 16 oz. of orange or apple beverage per day for 4 week&#xD;
             periods&#xD;
&#xD;
          -  Willing to maintain usual diet, smoking status, physical activity pattern, supplements&#xD;
             and meds&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Food allergies or sensitivities to ingredients in study beverages&#xD;
&#xD;
          -  Presence or history of GI condition, endocrine (including diabetes), cardiovascular&#xD;
             disease or other disease or condition that could interfere in the interpretation of&#xD;
             the study results in the opinion of the Investigator.&#xD;
&#xD;
          -  Extreme dietary habits including vegetarian, vegan or Atkins diet&#xD;
&#xD;
          -  Females or are pregnant, planning to become pregnant or breast feeding during the&#xD;
             study period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathleen Kelley, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>BioFortis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BioFortis</name>
      <address>
        <city>Addison</city>
        <state>Illinois</state>
        <zip>60101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>December 17, 2019</last_update_submitted>
  <last_update_submitted_qc>December 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03749031
org study id: PEP-1805
nct id: NCT03749031
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomized crossover intervention designed to evaluate effects of daily intake of
      beverages containing orange or apple Pomace on gastrointestinal function as measured by stool
      frequency. Additional outcomes will include aspects of digestive health and self-reported GI
      symptoms and dietary intake as well as analysis of gut microbiota.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: stool frequency
time frame: Changes over 7 weeks (daily during 4 week treatment followed by daily during 3 week washout) compared to baseline (daily during 2 week run-in)
description: Bowel habits daily diary as weekly averages. Fewer days with no stool, and higher number of stools per week would be better.
measure: Self-reported GI symptoms
time frame: Changes over 7 weeks (daily during 4 week treatment followed by daily during 3 week washout) compared to baseline (daily during 2 week run-in)
description: GI Tolerability questionnaire, 4 selections. The minimum value is Less than usual. The maximum value is Much more than usual. Pomace treament arms expected to have more GI symptoms than juice arms. Less symptoms are better than more.
measure: Stool consistency
time frame: Changes over 7 weeks (daily during 4 week treatment followed by daily during 3 week washout) compared to baseline (daily during 2 week run-in)
description: Bristol score, 7 types of stool drawings presented in a chart from lumpy Type 1, to watery Type 7. Improved consistency would be better.
measure: Ease of stool passage
time frame: Changes over 7 weeks (daily during 4 week treatment followed by daily during 3 week washout) compared to baseline (daily during 2 week run-in)
description: Rating scale 1 (Very easy) to 5 (Very difficult). Easier passage would be better.
measure: microbiota changes
time frame: Changes from baseline sample to end of treatment sample (Week 4) and end of 3 week washout sample (Week 7)
description: Stool samples for possible explanations of mechanisms of pomace. Higher bacteria associated with fiber fermentation would be better. Species examined include F. Prau, lachnospiraceae, ruminoucoccaceae, bifidobacteria, and changes in alpha and beta diversity as measured by 16S RNA sequencing. Data pending, unknown units at this time.
measure: Dietary analysis
time frame: Changes from 2 week run in (baseline) to the last week of treatment (Week 4) and the last week of 3 week washout (Week 7)
description: 3-day diet record. Expecting higher daily fiber intake for pomace arms.
arm group label: Orange juice only
arm group type: Placebo Comparator
description: 16 oz. orange juice per day for 4 weeks
arm group label: orange juice + orange Pomace
arm group type: Experimental
description: 16 oz. orange juice + orange Pomace per day for 4 weeks
arm group label: Apple juice only
arm group type: Placebo Comparator
description: 16 oz. apple juice per day for 4 weeks
arm group label: Apple Juice + Apple Pomace
arm group type: Experimental
description: 16 oz. apple juice + apple Pomace per day for 4 weeks
intervention type: Other
intervention name: Orange juice + Orange Pomace
description: 16 oz. orange juice + orange Pomace per day for 4 weeks
arm group label: orange juice + orange Pomace
intervention type: Other
intervention name: Orange Juice
description: 16 oz. orange juice per day for 4 weeks
arm group label: Orange juice only
intervention type: Other
intervention name: Apple Juice and Apple Pomace
description: 16 oz. apple juice and apple Pomace per day for 4 weeks
arm group label: Apple Juice + Apple Pomace
intervention type: Other
intervention name: Apple Juice
description: 16 oz. apple juice per day for 4 weeks
arm group label: Apple juice only
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kathleen Kelley, MD
role: Principal Investigator
affiliation: BioFortis
facility: 
country: United States
responsible party type: Sponsor