<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/NCT03765606</url>
  </required_header>
  <id_info>
    <org_study_id>UREC/18/0007</org_study_id>
    <nct_id>NCT03765606</nct_id>
  </id_info>
  <brief_title>Cocoa Ileostomy Study</brief_title>
  <official_title>The Bioavailability of Cocoa Flavan-3-ols and Interaction With the Methylxanthine, Theobromine: a Study With Ileostomists</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Ulster</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Ulster</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>
      There is substantial interest in the potential role of chocolate and its primary bioactive&#xD;
      component; flavan-3-ol, (-)-epicatechin, in both the prevention and management of&#xD;
      cardiovascular disease (CVD). Numerous observational studies have found the association&#xD;
      between high cocoa intake and a reduced CVD risk and mortality, yet the impact of these&#xD;
      mechanisms in vivo is unclear. In order to have a beneficial effect, these cocoa flavan-3-ols&#xD;
      must be absorbed in the body in a forms, while still maintaining its advantageous&#xD;
      characteristics. Consumption studies with ileostomists who have had their colon&#xD;
      removed,provide information regarding the bioavailability and bioactivity of (-)-epicatechin&#xD;
      and flavan-3-ols from cocoa, therefore the aim of this study is to determine the impact of&#xD;
      methylaxanthines (including theobromine) on bioavailability of cocoa flavan-3-ols prior to&#xD;
      entering the colon.&#xD;
&#xD;
      This study has a randomised double blinded crossover control design, being applied to&#xD;
      ileostomy patients who are aged 18-65 years, N=10, 5 per group. The study is divided into two&#xD;
      phases. During the first phase, subjects will partake in a 2-day restriction diet (No&#xD;
      phenolic foods) and an overnight fast prior to sampling. Ileal fluid (0hr) is obtained from&#xD;
      participants. They will then be asked to consume the cocoa flavanol beverage dissolved in&#xD;
      310g 1% milk. After this urine and ieal fluid is collected every 4 hours at 3 more time&#xD;
      points and blood every hour at 8 time points. A 24 hr urine and ieal fluid sample is&#xD;
      collected the following day. There will be a 1-week wash out period between each phase.&#xD;
      Procedure is repeated again for phase 2.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 9, 2018</start_date>
  <completion_date type="Actual">May 4, 2018</completion_date>
  <primary_completion_date type="Actual">May 4, 2018</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>
    <intervention_model_description>Randomised double-blinded crossover</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double-blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>cocoa flavan-3-ols bio-availability</measure>
    <time_frame>24-hour period post-consumption</time_frame>
    <description>Recovery of ingested flavan-3-ols in ileal fluid</description>
  </primary_outcome>
  <primary_outcome>
    <measure>cocoa flavan-3-ols bio-availability</measure>
    <time_frame>Change over 8-hour period post-consumption</time_frame>
    <description>Uptake of ingested flavan-3-ols in plasma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>cocoa flavan-3-ols availability</measure>
    <time_frame>Change over 24-hour period post-consumption</time_frame>
    <description>Recovery of ingested flavan-3-ols in urine</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Simulated gut microbiota</measure>
    <time_frame>Change over 24-hour in vitro fermentation period</time_frame>
    <description>Ileal fluid with/without simulated colonic fermentation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Ileostomy - Stoma</condition>
  <arm_group>
    <arm_group_label>Cocoa Flavanol beverage mix</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Cocoa Flavanol beverage mix (flavanols, 566mg; caffeine, 11mg &amp; theobromine, 93mg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>De-xanthinated Cocoa Flavanol beverage mix</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>De-xanthinated Cocoa Flavanol beverage mix (flavanols, 583mg; caffeine, 0.6mg &amp; theobromine, 0.2mg)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Cocoa Flavanol beverage mix</intervention_name>
    <description>Acute consumption of single portion of cocoa powder dissolved in 310g 1% milk.</description>
    <arm_group_label>Cocoa Flavanol beverage mix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>De-xanthinated Cocoa Flavanol beverage mix</intervention_name>
    <description>Acute consumption of single portion of cocoa powder dissolved in 310g 1% milk.</description>
    <arm_group_label>De-xanthinated Cocoa Flavanol beverage mix</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undergone an ileostomy and be more than 1.5-years post-operative&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Aged between 18-65 years&#xD;
&#xD;
          -  Non-smoking&#xD;
&#xD;
          -  Not lactose/milk/dairy intolerant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has not undergone an ileostomy and/or is less than 1.5 year post-operative&#xD;
&#xD;
          -  Pregnant/ lactating females&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Lactose/milk/diary intolerant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Human Intervention Studies Unit, Ulster University</name>
      <address>
        <city>Coleraine</city>
        <state>Co.Londonderry</state>
        <zip>BT52 1SA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>December 4, 2018</last_update_submitted>
  <last_update_submitted_qc>December 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cocoa Flavan-3-ols</keyword>
  <keyword>methylaxanthin</keyword>
  <keyword>theobromine</keyword>
  <keyword>Ileostomists</keyword>
  <keyword>bioavailability</keyword>
  <keyword>randomised controlled trial</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/NCT03765606
org study id: UREC/18/0007
nct id: NCT03765606
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There is substantial interest in the potential role of chocolate and its primary bioactive
      component; flavan-3-ol, (-)-epicatechin, in both the prevention and management of
      cardiovascular disease (CVD). Numerous observational studies have found the association
      between high cocoa intake and a reduced CVD risk and mortality, yet the impact of these
      mechanisms in vivo is unclear. In order to have a beneficial effect, these cocoa flavan-3-ols
      must be absorbed in the body in a forms, while still maintaining its advantageous
      characteristics. Consumption studies with ileostomists who have had their colon
      removed,provide information regarding the bioavailability and bioactivity of (-)-epicatechin
      and flavan-3-ols from cocoa, therefore the aim of this study is to determine the impact of
      methylaxanthines (including theobromine) on bioavailability of cocoa flavan-3-ols prior to
      entering the colon.

      This study has a randomised double blinded crossover control design, being applied to
      ileostomy patients who are aged 18-65 years, N=10, 5 per group. The study is divided into two
      phases. During the first phase, subjects will partake in a 2-day restriction diet (No
      phenolic foods) and an overnight fast prior to sampling. Ileal fluid (0hr) is obtained from
      participants. They will then be asked to consume the cocoa flavanol beverage dissolved in
      310g 1% milk. After this urine and ieal fluid is collected every 4 hours at 3 more time
      points and blood every hour at 8 time points. A 24 hr urine and ieal fluid sample is
      collected the following day. There will be a 1-week wash out period between each phase.
      Procedure is repeated again for phase 2.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomised double-blinded crossover
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Double-blinded
measure: cocoa flavan-3-ols bio-availability
time frame: 24-hour period post-consumption
description: Recovery of ingested flavan-3-ols in ileal fluid
measure: cocoa flavan-3-ols bio-availability
time frame: Change over 8-hour period post-consumption
description: Uptake of ingested flavan-3-ols in plasma
measure: cocoa flavan-3-ols availability
time frame: Change over 24-hour period post-consumption
description: Recovery of ingested flavan-3-ols in urine
measure: Simulated gut microbiota
time frame: Change over 24-hour in vitro fermentation period
description: Ileal fluid with/without simulated colonic fermentation
arm group label: Cocoa Flavanol beverage mix
arm group type: Placebo Comparator
description: Cocoa Flavanol beverage mix (flavanols, 566mg; caffeine, 11mg & theobromine, 93mg)
arm group label: De-xanthinated Cocoa Flavanol beverage mix
arm group type: Experimental
description: De-xanthinated Cocoa Flavanol beverage mix (flavanols, 583mg; caffeine, 0.6mg & theobromine, 0.2mg)
intervention type: Dietary Supplement
intervention name: Cocoa Flavanol beverage mix
description: Acute consumption of single portion of cocoa powder dissolved in 310g 1% milk.
arm group label: Cocoa Flavanol beverage mix
intervention type: Dietary Supplement
intervention name: De-xanthinated Cocoa Flavanol beverage mix
description: Acute consumption of single portion of cocoa powder dissolved in 310g 1% milk.
arm group label: De-xanthinated Cocoa Flavanol beverage mix
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No