<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/NCT03022955</url>
  </required_header>
  <id_info>
    <org_study_id>Chocolate Study</org_study_id>
    <nct_id>NCT03022955</nct_id>
  </id_info>
  <brief_title>Effects of Cocoa on Gastrointestinal Function</brief_title>
  <official_title>Effects of Cocoa Solids on Gastrointestinal Transit, Postprandial Sensation and Gastrointestinal Well-being: a Randomized, Controlled Trial in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, controlled, 2x2 cross-over study to assess the effects of cocoa solids&#xD;
      on gastrointestinal transit, post-prandial sensation and well-being. Additionally functional&#xD;
      brain imaging will be applied to identify regions of brain that are activated or inactivated&#xD;
      by cocoa ingestion. Healthy subjects will be recruited and randomized to receive either dark&#xD;
      chocolate (70% cocoa solids) or white chocolate (0% cocoa solids) in addition to their normal&#xD;
      diet in randomized order. Reference standard methodology will be applied to measure gastric&#xD;
      emptying, oro-caecal and colonic transit time. Dark and white chocolate (100g, ~500kcal, ~50%&#xD;
      fat) will be consumed with radio-opaque markers on three consecutive days. On the third day&#xD;
      chocolate ingestion will be followed by measurements of postprandial brain activity using&#xD;
      FDG-Positron Emission Tomography. Additionally colonic transit will be assessed based on the&#xD;
      number and distribution of radio-opaque markers in the colon. On the fourth day gastric&#xD;
      emptying and oro-caecal transit time will be assessed by scintigraphy after ingestion of a&#xD;
      dark or white chocolate mousse test meal (both 150g, ~500kcal, ~50% fat). During both&#xD;
      interventional studies pre- and post-prandial satiety and dyspeptic symptoms, well-being and&#xD;
      mood will be recorded. Additionally, validated questionnaires will assess digestive comfort&#xD;
      and well-bring at the end of each study day. These results will deliver comprehensive&#xD;
      information about the effects of cocoa on gastrointestinal transit and sensation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gastric emptying half time</measure>
    <time_frame>Baseline until 2 hours postingestion</time_frame>
    <description>assessed by scintigraphy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oro-caecal transit time (OCTT)</measure>
    <time_frame>Baseline until 3 hours postingestion</time_frame>
    <description>assessed by scintigraphy and 13-C Lactose-Ureide</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Colonic transit time</measure>
    <time_frame>Baseline until 3 days after ingestion</time_frame>
    <description>assessed by radio-opaque marker technique</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-prandial satiety</measure>
    <time_frame>changes from baseline to three hours after treatment</time_frame>
    <description>assessed by visual analogue scales</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal well-being</measure>
    <time_frame>changes from baseline to three hours after treatment</time_frame>
    <description>assessed by Likert scale</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Gastrointestinal and Digestive Disorder</condition>
  <arm_group>
    <arm_group_label>Dark chocolate: FDG-PET</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100 g dark chocolate bar (70% cocoa solids (~500kcal, ~50% fat)) will be consumed with radio-opaque markers on three consecutive days. On the third day chocolate ingestion will be followed by measurements of postprandial brain activity and colonic transit using chocolate: fluorodeoxyglucose Positron Emission Tomography (FDG-PET)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dark chocolate: Physiological Measurement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>150 g dark chocolate mousse (~500kcal, ~50% fat) labelled with 13C-lactose-ureide and technetium (99Tc) will be consumed to assess gastric emptying and oro-caecal transit time by scintigraphy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>White chocolate: FDG-PET</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>100 g white chocolate bar (0% cocoa solids (~500kcal, 50% fat) will be consumed with radio-opaque markers on three consecutive days. On the third day chocolate ingestion will be followed by measurements of postprandial brain activity and colonic transit using FDG-Positron Emission Tomography.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>White chocolate: Physiological Measurement</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>150 g white chocolate mousse (~500kcal, ~50% fat) labelled with 13C-lactose-ureide and technetium (99Tc) will be consumed to assess gastric emptying and oro-caecal transit time by scintigraphy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Dark chocolate bar</intervention_name>
    <description>Dark chocolate bar (70% cocoa solids (~500kcal, ~50% fat)), 100g / day for 3 days to assess postprandial brain activity and colonic transit by FDG-PET.</description>
    <arm_group_label>Dark chocolate: FDG-PET</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Dark chocolate mousse</intervention_name>
    <description>Dark chocolate mousse (150g, ~500kcal, ~50% fat) to assess gastric emptying and oro-caecal transit time by scintigraphy.</description>
    <arm_group_label>Dark chocolate: Physiological Measurement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>White chocolate bar</intervention_name>
    <description>White chocolate bar (0% cocoa solids (~500kcal, 50% fat)), 100g / day for 3 days to assess postprandial brain activity and colonic transit by FDG-PET.</description>
    <arm_group_label>White chocolate: FDG-PET</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>White chocolate mousse</intervention_name>
    <description>White chocolate mousse (150g, ~500kcal, ~50% fat) to assess gastric emptying and oro-caecal transit time by scintigraphy.</description>
    <arm_group_label>White chocolate: Physiological Measurement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers (men and women)&#xD;
&#xD;
          -  aged 18-65 years&#xD;
&#xD;
          -  body mass index 18-30kg/m2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  special dietary requirements incompatible with dietary intervention (food allergies or&#xD;
             intolerances)&#xD;
&#xD;
          -  clinically significant concomitant disease states (e.g., renal failure, hepatic&#xD;
             dysfunction, cardiovascular disease, etc.) that preclude intake of test meals&#xD;
&#xD;
          -  participation in another study with investigational drug within the 30 days preceding&#xD;
             and during the present study (purely diagnostic studies are acceptable)&#xD;
&#xD;
          -  individuals unwilling to provide written informed consent&#xD;
&#xD;
          -  inability to follow the procedures of the study, e.g. due to language problems (all&#xD;
             study documents in English)&#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>
  <overall_official>
    <last_name>Mark Fox, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Claraspital Basel, Abdominal Center: Gastroenterology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St Claraspital</name>
      <address>
        <city>Basel</city>
        <zip>4016</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>February 9, 2018</last_update_submitted>
  <last_update_submitted_qc>February 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Digestive System Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03022955
org study id: Chocolate Study
nct id: NCT03022955
lead sponsor: 
has dmc: No
This is a randomized, controlled, 2x2 cross-over study to assess the effects of cocoa solids
      on gastrointestinal transit, post-prandial sensation and well-being. Additionally functional
      brain imaging will be applied to identify regions of brain that are activated or inactivated
      by cocoa ingestion. Healthy subjects will be recruited and randomized to receive either dark
      chocolate (70% cocoa solids) or white chocolate (0% cocoa solids) in addition to their normal
      diet in randomized order. Reference standard methodology will be applied to measure gastric
      emptying, oro-caecal and colonic transit time. Dark and white chocolate (100g, ~500kcal, ~50%
      fat) will be consumed with radio-opaque markers on three consecutive days. On the third day
      chocolate ingestion will be followed by measurements of postprandial brain activity using
      FDG-Positron Emission Tomography. Additionally colonic transit will be assessed based on the
      number and distribution of radio-opaque markers in the colon. On the fourth day gastric
      emptying and oro-caecal transit time will be assessed by scintigraphy after ingestion of a
      dark or white chocolate mousse test meal (both 150g, ~500kcal, ~50% fat). During both
      interventional studies pre- and post-prandial satiety and dyspeptic symptoms, well-being and
      mood will be recorded. Additionally, validated questionnaires will assess digestive comfort
      and well-bring at the end of each study day. These results will deliver comprehensive
      information about the effects of cocoa on gastrointestinal transit and sensation.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Gastric emptying half time
time frame: Baseline until 2 hours postingestion
description: assessed by scintigraphy
measure: Oro-caecal transit time (OCTT)
time frame: Baseline until 3 hours postingestion
description: assessed by scintigraphy and 13-C Lactose-Ureide
measure: Colonic transit time
time frame: Baseline until 3 days after ingestion
description: assessed by radio-opaque marker technique
measure: Post-prandial satiety
time frame: changes from baseline to three hours after treatment
description: assessed by visual analogue scales
measure: Gastrointestinal well-being
time frame: changes from baseline to three hours after treatment
description: assessed by Likert scale
arm group label: Dark chocolate: FDG-PET
arm group type: Active Comparator
description: 100 g dark chocolate bar (70% cocoa solids (~500kcal, ~50% fat)) will be consumed with radio-opaque markers on three consecutive days. On the third day chocolate ingestion will be followed by measurements of postprandial brain activity and colonic transit using chocolate: fluorodeoxyglucose Positron Emission Tomography (FDG-PET)
arm group label: Dark chocolate: Physiological Measurement
arm group type: Active Comparator
description: 150 g dark chocolate mousse (~500kcal, ~50% fat) labelled with 13C-lactose-ureide and technetium (99Tc) will be consumed to assess gastric emptying and oro-caecal transit time by scintigraphy.
arm group label: White chocolate: FDG-PET
arm group type: Placebo Comparator
description: 100 g white chocolate bar (0% cocoa solids (~500kcal, 50% fat) will be consumed with radio-opaque markers on three consecutive days. On the third day chocolate ingestion will be followed by measurements of postprandial brain activity and colonic transit using FDG-Positron Emission Tomography.
arm group label: White chocolate: Physiological Measurement
arm group type: Placebo Comparator
description: 150 g white chocolate mousse (~500kcal, ~50% fat) labelled with 13C-lactose-ureide and technetium (99Tc) will be consumed to assess gastric emptying and oro-caecal transit time by scintigraphy.
intervention type: Dietary Supplement
intervention name: Dark chocolate bar
description: Dark chocolate bar (70% cocoa solids (~500kcal, ~50% fat)), 100g / day for 3 days to assess postprandial brain activity and colonic transit by FDG-PET.
arm group label: Dark chocolate: FDG-PET
intervention type: Dietary Supplement
intervention name: Dark chocolate mousse
description: Dark chocolate mousse (150g, ~500kcal, ~50% fat) to assess gastric emptying and oro-caecal transit time by scintigraphy.
arm group label: Dark chocolate: Physiological Measurement
intervention type: Dietary Supplement
intervention name: White chocolate bar
description: White chocolate bar (0% cocoa solids (~500kcal, 50% fat)), 100g / day for 3 days to assess postprandial brain activity and colonic transit by FDG-PET.
arm group label: White chocolate: FDG-PET
intervention type: Dietary Supplement
intervention name: White chocolate mousse
description: White chocolate mousse (150g, ~500kcal, ~50% fat) to assess gastric emptying and oro-caecal transit time by scintigraphy.
arm group label: White chocolate: Physiological Measurement
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mark Fox, Prof. Dr.
role: Principal Investigator
affiliation: St. Claraspital Basel, Abdominal Center: Gastroenterology
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Digestive System Diseases
sharing ipd: Undecided