<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/NCT01667523</url>
  </required_header>
  <id_info>
    <org_study_id>MEC 10-3-058</org_study_id>
    <nct_id>NCT01667523</nct_id>
  </id_info>
  <brief_title>The Effect of Capsaicin and Cinnamaldehyde on Intestinal Permeability</brief_title>
  <official_title>The Effect of Capsaicin and Cinnamaldehyde on Intestinal Permeability, Gallbladder Motility and Satiety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Top Institute Food and Nutrition</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      An altered permeability has been proposed to play an important role in the pathogenesis of&#xD;
      several gastrointestinal disorders, such as irritable bowel syndrome and inflammatory bowel&#xD;
      disease. Nutrients derived from food are able to influence the permeability of the intestine&#xD;
      and can therefore also affect gastrointestinal symptoms. In this study, the investigators&#xD;
      will investigate the effects of capsaicine and cinnamaldehyde, which can be found in hot&#xD;
      peppers and cinnamon, respectively, on gastrointestinal physiology.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To obtain more information about the effects of capsaicin and cinnamaldehyde on the&#xD;
      intestine, these substances will be infused directly in the duodenum. Hereafter, the&#xD;
      permeability of the intestine, gallbladder motility and the effects on satiety will be&#xD;
      assessed.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      Duodenal capsaicin and cinnamaldehyde infusion induces changes in the intestinal epithelial&#xD;
      barrier function by selectively acting on TRPV1 and TRPA1 receptors and releasing serotonin&#xD;
      from enterochromaffin cells as determined by the multi sugar permeability test&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">June 2011</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To assess the effect of capsaicin and cinnamaldehyde (CA) infusion on intestinal permeability</measure>
    <time_frame>Measured at start and end of infusion (30 min), on each of the 3 test days</time_frame>
    <description>Measurements performed in plasma</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To assess the effect of capsaicin and CA infusion on the activation of the TRP receptors as defined by the mucosal concentrations of the neuropeptides SP, CGRP and NKA</measure>
    <time_frame>1 day</time_frame>
    <description>Measurements will be performed in mucosal biopsy samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess the effect capsaicin and CA on parameters that are known to be associated with satiety, measured by satiety hormones in blood plasma and mucosal tissue (CCK) as well as satiety scoring on a visual analogue scale</measure>
    <time_frame>1 day</time_frame>
    <description>Visual analogue scores will be collected from the start of the infusion until 90 minutes thereafter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess the effect of capsaicin and CA on serotonergic function in duodenal biopsy specimens by measuring serotonin and its metabolites by HPLC</measure>
    <time_frame>1 day</time_frame>
    <description>Measurements will be performed on biopsy specimens</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess the effect of capsaicin and CA on gallbladder motility by ultrasound</measure>
    <time_frame>Measurements will be performed during the testday starting from 08.00 AM to 11.00AM</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess the effect of capsaicin and CA on the expression of tight junction proteins measured by immunohistochemistry and by quantitative PCR</measure>
    <time_frame>1 day</time_frame>
    <description>Measurements will be performed in biopsy specimens of the duodenal mucosa</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Capsaicin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Cinnamaldehyde</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Physiological saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Capsaicin</intervention_name>
    <description>1.5 mg capsaicin administered intraduodenally</description>
    <arm_group_label>Capsaicin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Cinnamaldehyde</intervention_name>
    <description>70 mg per intervention administered intraduodenally</description>
    <arm_group_label>Cinnamaldehyde</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Physiological saline</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Based on medical history and previous examination, no gastrointestinal complaints can&#xD;
             be defined.&#xD;
&#xD;
          2. Age between 18 and 65 years. This study will include healthy adult subjects. Subjects&#xD;
             over 65 years have an increased risk for comorbidities, therefore, subjects over 65&#xD;
             years will not be included. Furthermore, age has an influence on the homeostasis of&#xD;
             the intestinal mucosa [21], which can potentially influence outcome parameters of the&#xD;
             study.&#xD;
&#xD;
          3. BMI between 20 and 30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic,&#xD;
             hematological/immunologic, HEENT (head, ears, eyes, nose, throat),&#xD;
             dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine,&#xD;
             neurological/psychiatric diseases, allergy, major surgery and/or laboratory&#xD;
             assessments which might limit participation in or completion of the study protocol.&#xD;
             The severity of the disease (major interference with the execution of the experiment&#xD;
             or potential influence on the study outcomes) will be decided by the principal&#xD;
             investigator.&#xD;
&#xD;
          2. Use of medication, including vitamin supplementation, except oral contraceptives,&#xD;
             within 14 days prior to testing&#xD;
&#xD;
          3. Administration of investigational drugs or participation in any scientific&#xD;
             intervention study which may interfere with this study (to be decided by the principle&#xD;
             investigator), in the 180 days prior to the study&#xD;
&#xD;
          4. Major abdominal surgery interfering with gastrointestinal function (uncomplicated&#xD;
             appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon&#xD;
             judgement of the principle investigator)&#xD;
&#xD;
          5. Dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological&#xD;
             dynamic), pregnancy, lactation&#xD;
&#xD;
          6. Excessive alcohol consumption (&gt;20 alcoholic consumptions per week)&#xD;
&#xD;
          7. Smoking&#xD;
&#xD;
          8. Blood donation within 3 months before the study period&#xD;
&#xD;
          9. Self-admitted HIV-positive state&#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>Ad Masclee, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maastricht University Medical Center+</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <zip>6202 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>April 12, 2011</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>August 16, 2012</last_update_submitted>
  <last_update_submitted_qc>August 16, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 17, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Maastricht University Medical Center</investigator_affiliation>
    <investigator_full_name>Gastro</investigator_full_name>
    <investigator_title>Professor Ad. AAM Masclee</investigator_title>
  </responsible_party>
  <keyword>capsaicin</keyword>
  <keyword>cinnamaldehyde</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cinnamaldehyde</mesh_term>
    <mesh_term>Capsaicin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01667523
org study id: MEC 10-3-058
nct id: NCT01667523
lead sponsor: 
collaborator: 
has dmc: No
An altered permeability has been proposed to play an important role in the pathogenesis of
      several gastrointestinal disorders, such as irritable bowel syndrome and inflammatory bowel
      disease. Nutrients derived from food are able to influence the permeability of the intestine
      and can therefore also affect gastrointestinal symptoms. In this study, the investigators
      will investigate the effects of capsaicine and cinnamaldehyde, which can be found in hot
      peppers and cinnamon, respectively, on gastrointestinal physiology.

      Objective:

      To obtain more information about the effects of capsaicin and cinnamaldehyde on the
      intestine, these substances will be infused directly in the duodenum. Hereafter, the
      permeability of the intestine, gallbladder motility and the effects on satiety will be
      assessed.

      Hypothesis:

      Duodenal capsaicin and cinnamaldehyde infusion induces changes in the intestinal epithelial
      barrier function by selectively acting on TRPV1 and TRPA1 receptors and releasing serotonin
      from enterochromaffin cells as determined by the multi sugar permeability test
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: To assess the effect of capsaicin and cinnamaldehyde (CA) infusion on intestinal permeability
time frame: Measured at start and end of infusion (30 min), on each of the 3 test days
description: Measurements performed in plasma
measure: To assess the effect of capsaicin and CA infusion on the activation of the TRP receptors as defined by the mucosal concentrations of the neuropeptides SP, CGRP and NKA
time frame: 1 day
description: Measurements will be performed in mucosal biopsy samples
measure: To assess the effect capsaicin and CA on parameters that are known to be associated with satiety, measured by satiety hormones in blood plasma and mucosal tissue (CCK) as well as satiety scoring on a visual analogue scale
time frame: 1 day
description: Visual analogue scores will be collected from the start of the infusion until 90 minutes thereafter.
measure: To assess the effect of capsaicin and CA on serotonergic function in duodenal biopsy specimens by measuring serotonin and its metabolites by HPLC
time frame: 1 day
description: Measurements will be performed on biopsy specimens
measure: To assess the effect of capsaicin and CA on gallbladder motility by ultrasound
time frame: Measurements will be performed during the testday starting from 08.00 AM to 11.00AM
measure: To assess the effect of capsaicin and CA on the expression of tight junction proteins measured by immunohistochemistry and by quantitative PCR
time frame: 1 day
description: Measurements will be performed in biopsy specimens of the duodenal mucosa
arm group label: Capsaicin
arm group type: Experimental
arm group label: Cinnamaldehyde
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
description: Physiological saline
intervention type: Dietary Supplement
intervention name: Capsaicin
description: 1.5 mg capsaicin administered intraduodenally
arm group label: Capsaicin
intervention type: Dietary Supplement
intervention name: Cinnamaldehyde
description: 70 mg per intervention administered intraduodenally
arm group label: Cinnamaldehyde
intervention type: Dietary Supplement
intervention name: Placebo
description: Physiological saline
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ad Masclee, MD PhD
role: Principal Investigator
affiliation: Maastricht University Medical Center
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Maastricht University Medical Center
investigator full name: Gastro
investigator title: Professor Ad. AAM Masclee
mesh term: Cinnamaldehyde
mesh term: Capsaicin