<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/NCT02979496</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201602073</org_study_id>
    <nct_id>NCT02979496</nct_id>
  </id_info>
  <brief_title>Citrus Beverages and Gastrointestinal Function</brief_title>
  <acronym>POM</acronym>
  <official_title>The Effect of Citrus Beverages on Gastrointestinal Function in Healthy Adults: a Randomized, Double-blind, Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>PepsiCo, Inc.</agency>
      <agency_class>Industry</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 study is to evaluate the effect of daily intake of orange pomace on&#xD;
      gastrointestinal function as measured by stool frequency. Additional outcomes will include&#xD;
      aspects of digestive health, diet quality, and fasting blood glucose and lipid&#xD;
      concentrations. Possible explanations for the mechanism of the pomace will be explored in&#xD;
      microbial ecology analyses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this randomized, double-blind, controlled trial, healthy adults will be asked to consume&#xD;
      daily servings of orange juice containing either 0 g (n=120; control) or 180 g (i.e. 10 g&#xD;
      fiber; n=120) of orange pomace for 3 weeks to assess the effect of the pomace on stool&#xD;
      frequency. Blood samples will be obtained to assess the effect of the pomace on metabolic&#xD;
      markers. Stool samples will be collected for analyses of the effect of the pomace on fecal&#xD;
      bacteria known to be associated with health benefits (e.g., bifidobacteria). For exploratory&#xD;
      analyses, additional groups will be asked to consume orange juice containing 90 g of pomace&#xD;
      (i.e. 5 g fiber; n=40) or orange-flavored, calorie-matched water (n=40); outcomes from the&#xD;
      water group will be compared to those of the 0 g pomace juice group to assess any effects of&#xD;
      the juice alone, and outcomes from the 90 g pomace group will be compared to those of the 180&#xD;
      g and 0 g groups in microbiota analyses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 13, 2017</start_date>
  <completion_date type="Actual">April 29, 2017</completion_date>
  <primary_completion_date type="Actual">April 29, 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>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Stool Frequency</measure>
    <time_frame>Weeks -1,0,1,2,3</time_frame>
    <description>The average number of stools per week compared between intervention groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Stool frequency as a function of stool consistency</measure>
    <time_frame>Change from Weeks -1,0,1,2,3</time_frame>
    <description>The average number of stools per week compared between intervention groups, including Bristol Stool Score category (stool types 1-7 with 1 = hard and 7 = liquid ) as a covariate in the statistical model.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Diarrhea symptom score</measure>
    <time_frame>Change from Weeks -1,0,1,2,3</time_frame>
    <description>Measured By Gastrointestinal Symptom Response Scale (GSRS). Questionnaire asks participants about the previous seven days. Scores range from 1 (no discomfort) to 7 (very severe discomfort); lower scores are more desirable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Constipation symptom score</measure>
    <time_frame>Change from Weeks -1,0,1,2,3</time_frame>
    <description>Measured By Gastrointestinal Symptom Response Scale (GSRS). Questionnaire asks participants about the previous seven days. Scores range from 1 (no discomfort) to 7 (very severe discomfort); lower scores are more desirable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Indigestion symptom score</measure>
    <time_frame>Change from Weeks -1,0,1,2,3</time_frame>
    <description>Measured By Gastrointestinal Symptom Response Scale (GSRS). Questionnaire asks participants about the previous seven days. Scores range from 1 (no discomfort) to 7 (very severe discomfort); lower scores are more desirable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Reflux symptom score</measure>
    <time_frame>Change from Weeks -1,0,1,2,3</time_frame>
    <description>Measured By Gastrointestinal Symptom Response Scale (GSRS). Questionnaire asks participants about the previous seven days. Scores range from 1 (no discomfort) to 7 (very severe discomfort); lower scores are more desirable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Abdominal pain symptom score</measure>
    <time_frame>Change from Weeks -1,0,1,2,3</time_frame>
    <description>Measured By Gastrointestinal Symptom Response Scale (GSRS). Questionnaire asks participants about the previous seven days. Scores range from 1 (no discomfort) to 7 (very severe discomfort); lower scores are more desirable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Number of bifidobacteria in fecal samples</measure>
    <time_frame>Change from Weeks 0 and 3</time_frame>
    <description>Bifidobacteria in fecal samples will be quantified via quantitative polymerase chain reaction (qPCR) and compared between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting blood glucose</measure>
    <time_frame>Change from Weeks 0 and 3</time_frame>
    <description>Fasting blood glucose determined by Cholestech assay</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">330</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>0 g pomace (control)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>16 oz of juice containing 0 g of citrus pomace will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>90 g pomace</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>16 oz of juice containing 90 g of citrus pomace will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>180 g pomace</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>16 oz of juice containing 180 g of citrus pomace will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Flavored water (control)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>16 oz of a flavored, calorie-matched water beverage will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded).</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>0 g pomace (control)</intervention_name>
    <description>16 oz of juice containing 0 g of citrus pomace will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded)</description>
    <arm_group_label>0 g pomace (control)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>90 g pomace</intervention_name>
    <description>16 oz of juice containing 90 g of citrus pomace will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded).</description>
    <arm_group_label>90 g pomace</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>180 g pomace</intervention_name>
    <description>16 oz of juice containing 180 g of citrus pomace will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded).</description>
    <arm_group_label>180 g pomace</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Flavored water (control)</intervention_name>
    <description>16 oz of a flavored, calorie-matched water beverage will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded).</description>
    <arm_group_label>Flavored water (control)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adults 18-60 years of age&#xD;
&#xD;
          -  Willing and able to consume 16 oz. of a citrus beverage daily for the 3-week study&#xD;
             intervention&#xD;
&#xD;
          -  Willing and able to avoid consumption of any orange, grapefruit, tomato or V-8 juice&#xD;
             and whole oranges or grapefruits during the two weeks leading up to the study and&#xD;
             during the study, not including the study beverage&#xD;
&#xD;
          -  Willing and able to complete daily questionnaires online regarding dietary intake and&#xD;
             general health and well-being, including gastrointestinal habits Note: we will recruit&#xD;
             participants who will have Internet access for the duration of the protocol, but&#xD;
             understand that, once enrolled, situations may change. If this is the case, paper&#xD;
             copies of the online forms will be provided&#xD;
&#xD;
          -  Willing to discontinue any prebiotic, probiotic, and fiber supplements after&#xD;
             consenting&#xD;
&#xD;
          -  Willing to provide blood via finger prick and a stool sample twice each, once at the&#xD;
             beginning and once at the end of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are lactating, know that they are pregnant, or are attempting to get&#xD;
             pregnant&#xD;
&#xD;
          -  Currently being treated for any physician-diagnosed diseases or conditions&#xD;
&#xD;
          -  Vegetarians/vegans&#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>Bobbi Langkamp-Henken, PhD, RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida</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>October 2018</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>October 11, 2018</last_update_submitted>
  <last_update_submitted_qc>October 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>immune</keyword>
  <keyword>citrus</keyword>
  <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/NCT02979496
org study id: IRB201602073
nct id: NCT02979496
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the effect of daily intake of orange pomace on
      gastrointestinal function as measured by stool frequency. Additional outcomes will include
      aspects of digestive health, diet quality, and fasting blood glucose and lipid
      concentrations. Possible explanations for the mechanism of the pomace will be explored in
      microbial ecology analyses.
In this randomized, double-blind, controlled trial, healthy adults will be asked to consume
      daily servings of orange juice containing either 0 g (n=120; control) or 180 g (i.e. 10 g
      fiber; n=120) of orange pomace for 3 weeks to assess the effect of the pomace on stool
      frequency. Blood samples will be obtained to assess the effect of the pomace on metabolic
      markers. Stool samples will be collected for analyses of the effect of the pomace on fecal
      bacteria known to be associated with health benefits (e.g., bifidobacteria). For exploratory
      analyses, additional groups will be asked to consume orange juice containing 90 g of pomace
      (i.e. 5 g fiber; n=40) or orange-flavored, calorie-matched water (n=40); outcomes from the
      water group will be compared to those of the 0 g pomace juice group to assess any effects of
      the juice alone, and outcomes from the 90 g pomace group will be compared to those of the 180
      g and 0 g groups in microbiota analyses.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in Stool Frequency
time frame: Weeks -1,0,1,2,3
description: The average number of stools per week compared between intervention groups.
measure: Change in Stool frequency as a function of stool consistency
time frame: Change from Weeks -1,0,1,2,3
description: The average number of stools per week compared between intervention groups, including Bristol Stool Score category (stool types 1-7 with 1 = hard and 7 = liquid ) as a covariate in the statistical model.
measure: Change in Diarrhea symptom score
time frame: Change from Weeks -1,0,1,2,3
description: Measured By Gastrointestinal Symptom Response Scale (GSRS). Questionnaire asks participants about the previous seven days. Scores range from 1 (no discomfort) to 7 (very severe discomfort); lower scores are more desirable.
measure: Change in Constipation symptom score
time frame: Change from Weeks -1,0,1,2,3
description: Measured By Gastrointestinal Symptom Response Scale (GSRS). Questionnaire asks participants about the previous seven days. Scores range from 1 (no discomfort) to 7 (very severe discomfort); lower scores are more desirable.
measure: Change in Indigestion symptom score
time frame: Change from Weeks -1,0,1,2,3
description: Measured By Gastrointestinal Symptom Response Scale (GSRS). Questionnaire asks participants about the previous seven days. Scores range from 1 (no discomfort) to 7 (very severe discomfort); lower scores are more desirable.
measure: Change in Reflux symptom score
time frame: Change from Weeks -1,0,1,2,3
description: Measured By Gastrointestinal Symptom Response Scale (GSRS). Questionnaire asks participants about the previous seven days. Scores range from 1 (no discomfort) to 7 (very severe discomfort); lower scores are more desirable.
measure: Change in Abdominal pain symptom score
time frame: Change from Weeks -1,0,1,2,3
description: Measured By Gastrointestinal Symptom Response Scale (GSRS). Questionnaire asks participants about the previous seven days. Scores range from 1 (no discomfort) to 7 (very severe discomfort); lower scores are more desirable.
measure: Change in Number of bifidobacteria in fecal samples
time frame: Change from Weeks 0 and 3
description: Bifidobacteria in fecal samples will be quantified via quantitative polymerase chain reaction (qPCR) and compared between groups.
measure: Change in Fasting blood glucose
time frame: Change from Weeks 0 and 3
description: Fasting blood glucose determined by Cholestech assay
arm group label: 0 g pomace (control)
arm group type: Other
description: 16 oz of juice containing 0 g of citrus pomace will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded).
arm group label: 90 g pomace
arm group type: Experimental
description: 16 oz of juice containing 90 g of citrus pomace will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded).
arm group label: 180 g pomace
arm group type: Experimental
description: 16 oz of juice containing 180 g of citrus pomace will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded).
arm group label: Flavored water (control)
arm group type: Other
description: 16 oz of a flavored, calorie-matched water beverage will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded).
intervention type: Dietary Supplement
intervention name: 0 g pomace (control)
description: 16 oz of juice containing 0 g of citrus pomace will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded)
arm group label: 0 g pomace (control)
intervention type: Dietary Supplement
intervention name: 90 g pomace
description: 16 oz of juice containing 90 g of citrus pomace will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded).
arm group label: 90 g pomace
intervention type: Dietary Supplement
intervention name: 180 g pomace
description: 16 oz of juice containing 180 g of citrus pomace will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded).
arm group label: 180 g pomace
intervention type: Dietary Supplement
intervention name: Flavored water (control)
description: 16 oz of a flavored, calorie-matched water beverage will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded).
arm group label: Flavored water (control)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bobbi Langkamp-Henken, PhD, RD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No