<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/NCT02975856</url>
  </required_header>
  <id_info>
    <org_study_id>VINOFLAVO_02</org_study_id>
    <nct_id>NCT02975856</nct_id>
  </id_info>
  <brief_title>Bioavailability of Red Wine Anthocyanins</brief_title>
  <official_title>Bioavailability of Table Red Wine and Young Port Red Wine Anthocyanins</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade do Porto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>REQUIMTE/LAQV, Departamento de Química e Bioquímica, FCUP</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Center for Health Technology and Services Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vinoflavo</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidade do Porto</source>
  <brief_summary>
    <textblock>
      The main aim of this study is to evaluate the bioavailability of table red wine and young&#xD;
      Port red wine anthocyanins in healthy men.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anthocyanins (ANT) are water soluble pigments found in plants, flowers and fruits that are&#xD;
      consumed as part of the human diet, many times in higher amounts than other flavonoid&#xD;
      classes. Red wine is also an important source of anthocyanins, especially Mv3glc.&#xD;
&#xD;
      Several epidemiological studies have suggested that the consumption of anthocyanin-rich&#xD;
      foods, including the moderate consumption of red wine, is positively associated with the&#xD;
      prevention of cardiovascular heart disease.&#xD;
&#xD;
      It has become clear that the flavonoid bioactive forms in vivo are not necessarily those&#xD;
      which occur in nature, but metabolites arising after absorption takes place.Therefore,&#xD;
      studying the bioavailability of red wine ANT is very important to identify which metabolites&#xD;
      (originated in vivo) can actually reach the target organs (and in which concentrations) and&#xD;
      may be responsible for the postulated health benefits of red wine.&#xD;
&#xD;
      Intervention protocol:&#xD;
&#xD;
      Urine samples and peripheral venous blood (10 ml) will be collected from 10 h-fasting&#xD;
      subjects. Afterwards, each volunteer will consume 250 ml of table red wine or 150 ml of young&#xD;
      Port red wine and blood samples will be collected 15, 30, 60 and 120 min after wines&#xD;
      ingestion. Another urine sample will be collected at 120 min.&#xD;
&#xD;
      Table red wine 12 % (250 ml) and young Port red wine 20 % (150 ml), two different food&#xD;
      matrices rich in ANT, provided the same amount of ethanol (24 g of ethanol).&#xD;
&#xD;
      A thorough screening analysis for ANT will be performed in plasma and urine samples collected&#xD;
      from the volunteers at different time points.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2015</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma concentrations of anthocyanins and anthocyanins metabolites</measure>
    <time_frame>At baseline and 15, 30, 60 and 120 minutes after wines consumption</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urinary concentrations of anthocyanins and anthocyanins metabolites</measure>
    <time_frame>At baseline and 120 minutes after wines consumption</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Table Red Wine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>250 ml Table Red Wine (12% ethanol)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Young Port Red Wine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>150 ml Young Port Red Wine (20% ethanol)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Table Red Wine</intervention_name>
    <arm_group_label>Table Red Wine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Young Port Red Wine</intervention_name>
    <arm_group_label>Young Port Red Wine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men&#xD;
&#xD;
          -  Age 18-65 years&#xD;
&#xD;
          -  BMI &lt; 25 kg/m2&#xD;
&#xD;
          -  Willing and able to provide written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with current or previous CVD, diabetes or other severe chronic disease&#xD;
&#xD;
          -  Subjects under prescription of any chronic medication&#xD;
&#xD;
          -  Intake of red fruits or red wine in the last 24 h prior to the beginning of the&#xD;
             intervention&#xD;
&#xD;
          -  Subjects involved in any clinical or food study within the preceding month&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Conceição Calhau, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CINTESIS - Faculty of Medicine of University of Porto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CINTESIS - Faculty of Medicine of the University of Porto</name>
      <address>
        <city>Porto</city>
        <zip>4200-450</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>November 23, 2016</last_update_submitted>
  <last_update_submitted_qc>November 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anthocyanins</keyword>
  <keyword>Bioavailability</keyword>
  <keyword>Flavonoids</keyword>
  <keyword>Port wine</keyword>
  <keyword>Red wine</keyword>
  <!-- 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/NCT02975856
org study id: VINOFLAVO_02
nct id: NCT02975856
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
The main aim of this study is to evaluate the bioavailability of table red wine and young
      Port red wine anthocyanins in healthy men.
Anthocyanins (ANT) are water soluble pigments found in plants, flowers and fruits that are
      consumed as part of the human diet, many times in higher amounts than other flavonoid
      classes. Red wine is also an important source of anthocyanins, especially Mv3glc.

      Several epidemiological studies have suggested that the consumption of anthocyanin-rich
      foods, including the moderate consumption of red wine, is positively associated with the
      prevention of cardiovascular heart disease.

      It has become clear that the flavonoid bioactive forms in vivo are not necessarily those
      which occur in nature, but metabolites arising after absorption takes place.Therefore,
      studying the bioavailability of red wine ANT is very important to identify which metabolites
      (originated in vivo) can actually reach the target organs (and in which concentrations) and
      may be responsible for the postulated health benefits of red wine.

      Intervention protocol:

      Urine samples and peripheral venous blood (10 ml) will be collected from 10 h-fasting
      subjects. Afterwards, each volunteer will consume 250 ml of table red wine or 150 ml of young
      Port red wine and blood samples will be collected 15, 30, 60 and 120 min after wines
      ingestion. Another urine sample will be collected at 120 min.

      Table red wine 12 % (250 ml) and young Port red wine 20 % (150 ml), two different food
      matrices rich in ANT, provided the same amount of ethanol (24 g of ethanol).

      A thorough screening analysis for ANT will be performed in plasma and urine samples collected
      from the volunteers at different time points.
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Plasma concentrations of anthocyanins and anthocyanins metabolites
time frame: At baseline and 15, 30, 60 and 120 minutes after wines consumption
measure: Urinary concentrations of anthocyanins and anthocyanins metabolites
time frame: At baseline and 120 minutes after wines consumption
arm group label: Table Red Wine
arm group type: Experimental
description: 250 ml Table Red Wine (12% ethanol)
arm group label: Young Port Red Wine
arm group type: Experimental
description: 150 ml Young Port Red Wine (20% ethanol)
intervention type: Dietary Supplement
intervention name: Table Red Wine
arm group label: Table Red Wine
intervention type: Dietary Supplement
intervention name: Young Port Red Wine
arm group label: Young Port Red Wine
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Conceição Calhau, PhD
role: Principal Investigator
affiliation: CINTESIS - Faculty of Medicine of University of Porto
facility: 
country: Portugal
responsible party type: Sponsor