<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/NCT01681394</url>
  </required_header>
  <id_info>
    <org_study_id>PBMCS-CTNS-01</org_study_id>
    <nct_id>NCT01681394</nct_id>
  </id_info>
  <brief_title>Effect of a Polyphenol-rich Cocoa Extract on Peripheral Blood Mononuclear Cells Gene Expression</brief_title>
  <official_title>Effect of the Administration of a Polyphenol-rich Cocoa Extract on Peripheral Blood Mononuclear Cells Gene Expression in Humans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technological Centre of Nutrition and Health, Spain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Technological Centre of Nutrition and Health, Spain</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It has been evidenced that chocolate and cocoa consumption increase vasodilation and reduce&#xD;
      blood pressure. However, the mechanisms implicated in these effects have not been elucidated&#xD;
      yet. The purpose of this study is to evaluate changes in gene expression induced by the&#xD;
      administration of a polyphenol-rich cocoa extract in peripheral blood mononuclear cells&#xD;
      (PBMC) in humans.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized, controlled, double-blind and cross-over study. The&#xD;
      intervention will consist in the administration of 250g of chocolate cream with or without&#xD;
      the extract after 12 hours fasting. Blood samples will be taken at point 0, 2, 3 and 6 hours&#xD;
      after the administration. At each time point, blood pressure and endothelial function (with a&#xD;
      non-invasive method) will be measured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Gene expression changes in PBMCs (using a microarray)</measure>
    <time_frame>0-6 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>0-2-3-6 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endothelial function (assessed by ischemic reactive hyperemia)</measure>
    <time_frame>0-2-3-6 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma levels of procyanidins metabolites</measure>
    <time_frame>0-6 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Cardiovascular Function</condition>
  <condition>Gene Expression</condition>
  <arm_group>
    <arm_group_label>Product 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>250 g of chocolate cream supplemented with 2.3 g of polyphenol-rich cocoa extract (containing 1050 mg of total polyphenols)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control product</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>250 g of chocolate cream</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Polyphenol-rich cocoa extract</intervention_name>
    <description>250 g of chocolate cream supplemented with 2.3 g of polyphenol-rich cocoa extract (containing 1050 mg of total polyphenols)</description>
    <arm_group_label>Product 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Chocolate cream</intervention_name>
    <arm_group_label>Control product</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1.Healthy males between the ages of 20 and 39 who do not meet any of the exclusion&#xD;
        criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Body mass index (BMI) lower than 18 or greater than 27 Kg/m2&#xD;
&#xD;
          2. Smokers&#xD;
&#xD;
          3. Regular medication&#xD;
&#xD;
          4. Consumption of medication during the last week&#xD;
&#xD;
          5. Following a weight-loss diet&#xD;
&#xD;
          6. Vegetarians&#xD;
&#xD;
          7. Abnormal glucose levels&#xD;
&#xD;
          8. Diabetes&#xD;
&#xD;
          9. Cardiovascular disease&#xD;
&#xD;
         10. Gastrointestinal disease&#xD;
&#xD;
         11. Anemia&#xD;
&#xD;
         12. Allergy&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rosa Solà, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Rovira i Virgili</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Technological Center of Nutrition and Health (CTNS)</name>
      <address>
        <city>Reus</city>
        <state>Tarragona</state>
        <zip>43204</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>July 2, 2013</last_update_submitted>
  <last_update_submitted_qc>July 2, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 3, 2013</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/NCT01681394
org study id: PBMCS-CTNS-01
nct id: NCT01681394
lead sponsor: 
has dmc: No
It has been evidenced that chocolate and cocoa consumption increase vasodilation and reduce
      blood pressure. However, the mechanisms implicated in these effects have not been elucidated
      yet. The purpose of this study is to evaluate changes in gene expression induced by the
      administration of a polyphenol-rich cocoa extract in peripheral blood mononuclear cells
      (PBMC) in humans.
This is a prospective, randomized, controlled, double-blind and cross-over study. The
      intervention will consist in the administration of 250g of chocolate cream with or without
      the extract after 12 hours fasting. Blood samples will be taken at point 0, 2, 3 and 6 hours
      after the administration. At each time point, blood pressure and endothelial function (with a
      non-invasive method) will be measured.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Gene expression changes in PBMCs (using a microarray)
time frame: 0-6 hours
measure: Blood pressure
time frame: 0-2-3-6 hours
measure: Endothelial function (assessed by ischemic reactive hyperemia)
time frame: 0-2-3-6 hours
measure: Plasma levels of procyanidins metabolites
time frame: 0-6 hours
arm group label: Product 1
arm group type: Active Comparator
description: 250 g of chocolate cream supplemented with 2.3 g of polyphenol-rich cocoa extract (containing 1050 mg of total polyphenols)
arm group label: Control product
arm group type: Placebo Comparator
description: 250 g of chocolate cream
intervention type: Dietary Supplement
intervention name: Polyphenol-rich cocoa extract
description: 250 g of chocolate cream supplemented with 2.3 g of polyphenol-rich cocoa extract (containing 1050 mg of total polyphenols)
arm group label: Product 1
intervention type: Dietary Supplement
intervention name: Chocolate cream
arm group label: Control product
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rosa Solà, PhD
role: Principal Investigator
affiliation: University Rovira i Virgili
facility: 
country: Spain
responsible party type: Sponsor