<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/NCT01688154</url>
  </required_header>
  <id_info>
    <org_study_id>306724</org_study_id>
    <nct_id>NCT01688154</nct_id>
  </id_info>
  <brief_title>Ability of Grape Seed Proanthocyanidins to Reduce Postprandial Triglycerides in Humans</brief_title>
  <official_title>Ability of Grape Seed Proanthocyanidins to Reduce Postprandial Triglycerides in Humans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technological Centre of Nutrition and Health, Spain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Rovira i Virgili</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Universitari Sant Joan de Reus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Technological Centre of Nutrition and Health, Spain</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Grape seed proanthocyanidins have been reported to possess a hypotriglyceridemic effect after&#xD;
      an acute or chronic consumption in rodents. In this study, we aimed to investigate the&#xD;
      effects of an acute consumption of proanthocyanidins before a breakfast meal in humans.&#xD;
      Moreover, the mechanisms implicated in the reduction of plasma triglycerides levels by grape&#xD;
      seed proanthocyanidins in humans should be elucidated as well as its activity on vascular&#xD;
      function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intervention will consist in the administration of 2 capsules containing the grape seed&#xD;
      proanthocyanidins extract or 2 empty capsules (placebo) just before breakfast, which will&#xD;
      consist of 100g of white bread, 75g of salami, 50g of fatty cheese, 125g of yogurt (10% fat),&#xD;
      25ml of olive oil and water ad libitum. The nutritional composition of this meal is as&#xD;
      follows: 1.200 Kcal of energy content, 15% of energy from proteins, 22% from carbohydrates&#xD;
      and 63% from fat (35% saturated fat), and 120mg of cholesterol. Blood samples will be taken&#xD;
      at point 0.5,1,2,3 and 6 hours after breakfast. Moreover, urine samples will be collected at&#xD;
      time 0 and 6 hours.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>Area under the curve of plasma triglycerides concentration</measure>
    <time_frame>0-180 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>0-0.5-1-2-3-6 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endothelial function (assessed by ischemic reactive hyperemia)</measure>
    <time_frame>0-0.5-1-2-3-6 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood lipid levels, markers of inflammation and oxidation</measure>
    <time_frame>0-0.5-1-2-3-6 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma levels of procyanidins metabolites</measure>
    <time_frame>0-0.5-1-2-3-6 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers of cholesterol metabolism in PBMCs (mRNA and protein).</measure>
    <time_frame>0-0.5-1-2-3-6 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Membrane lipid composition of erythrocytes and oxidation markers.</measure>
    <time_frame>0-0.5-1-2-3-6 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-targeted metabolomics and 8-epi-prostaglandin-F2α levels (in urine)</measure>
    <time_frame>0-6 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Triglyceride Metabolism</condition>
  <condition>Cardiovascular Function</condition>
  <arm_group>
    <arm_group_label>Product 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>35 mg/Kg of grape seed proanthocyanidins extract (2 capsules)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control product</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 empty capsules</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>35 mg/Kg of grape seed proanthocyanidins extract (2 capsules)</intervention_name>
    <arm_group_label>Product 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>2 empty capsules</intervention_name>
    <arm_group_label>Control product</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults between the ages of 20 and 40&#xD;
&#xD;
          -  Signing the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body mass index (BMI) lower than 18.5 or greater than 27 Kg/m2&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Regular medication&#xD;
&#xD;
          -  Consumption of medication during the last week&#xD;
&#xD;
          -  Following a weight-loss diet&#xD;
&#xD;
          -  Vegetarians&#xD;
&#xD;
          -  Abnormal glucose levels&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Cardiovascular disease&#xD;
&#xD;
          -  Gastrointestinal disease&#xD;
&#xD;
          -  Anemia&#xD;
&#xD;
          -  Nuts allergy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 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>
  <overall_official>
    <last_name>Maria Cinta Bladé, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Rovira i Virgili</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CTNS</name>
      <address>
        <city>Reus</city>
        <state>Tarragona</state>
        <zip>43204</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <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 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Proanthocyanidin</mesh_term>
    <mesh_term>Procyanidin</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/NCT01688154
org study id: 306724
nct id: NCT01688154
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Grape seed proanthocyanidins have been reported to possess a hypotriglyceridemic effect after
      an acute or chronic consumption in rodents. In this study, we aimed to investigate the
      effects of an acute consumption of proanthocyanidins before a breakfast meal in humans.
      Moreover, the mechanisms implicated in the reduction of plasma triglycerides levels by grape
      seed proanthocyanidins in humans should be elucidated as well as its activity on vascular
      function.
The intervention will consist in the administration of 2 capsules containing the grape seed
      proanthocyanidins extract or 2 empty capsules (placebo) just before breakfast, which will
      consist of 100g of white bread, 75g of salami, 50g of fatty cheese, 125g of yogurt (10% fat),
      25ml of olive oil and water ad libitum. The nutritional composition of this meal is as
      follows: 1.200 Kcal of energy content, 15% of energy from proteins, 22% from carbohydrates
      and 63% from fat (35% saturated fat), and 120mg of cholesterol. Blood samples will be taken
      at point 0.5,1,2,3 and 6 hours after breakfast. Moreover, urine samples will be collected at
      time 0 and 6 hours.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Area under the curve of plasma triglycerides concentration
time frame: 0-180 minutes
measure: Blood pressure
time frame: 0-0.5-1-2-3-6 hours
measure: Endothelial function (assessed by ischemic reactive hyperemia)
time frame: 0-0.5-1-2-3-6 hours
measure: Blood lipid levels, markers of inflammation and oxidation
time frame: 0-0.5-1-2-3-6 hours
measure: Plasma levels of procyanidins metabolites
time frame: 0-0.5-1-2-3-6 hours
measure: Markers of cholesterol metabolism in PBMCs (mRNA and protein).
time frame: 0-0.5-1-2-3-6 hours
measure: Membrane lipid composition of erythrocytes and oxidation markers.
time frame: 0-0.5-1-2-3-6 hours
measure: Non-targeted metabolomics and 8-epi-prostaglandin-F2α levels (in urine)
time frame: 0-6 hours
arm group label: Product 1
arm group type: Active Comparator
description: 35 mg/Kg of grape seed proanthocyanidins extract (2 capsules)
arm group label: Control product
arm group type: Placebo Comparator
description: 2 empty capsules
intervention type: Dietary Supplement
intervention name: 35 mg/Kg of grape seed proanthocyanidins extract (2 capsules)
arm group label: Product 1
intervention type: Other
intervention name: 2 empty capsules
arm group label: Control product
criteria: 
gender: All
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rosa Solà, PhD
role: Principal Investigator
affiliation: University Rovira i Virgili
last name: Maria Cinta Bladé, PhD
role: Principal Investigator
affiliation: University Rovira i Virgili
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Proanthocyanidin
mesh term: Procyanidin