<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/NCT04438122</url>
  </required_header>
  <id_info>
    <org_study_id>HarokopioU</org_study_id>
    <nct_id>NCT04438122</nct_id>
  </id_info>
  <brief_title>Effect of Wine Consumption on Cardiovascular Markers in CHDs Patients</brief_title>
  <official_title>Effect of Light to Moderate Wine Consumption on Cardiovascular Markers in Coronary Heart Disease Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Harokopio University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Harokopio University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Many epidemiological studies support that 20-30gr of alcohol consumption per day is related&#xD;
      with lower risk for cardiovascular diseases, heart attack as well as mortality related to&#xD;
      these diseases. Since the French paradox was reported, a number of experimental and clinical&#xD;
      studies have demonstrated the protective effect of red wine compared to other alcoholic&#xD;
      drinks on different pathways of the pathogenesis of atherosclerosis. The investigator's&#xD;
      previous results revealed that wine contain micro-constituents that exert potent in vitro&#xD;
      anti-platelet and anti-inflammatory actions. Also, the wine consumption along with a&#xD;
      standardized meal reduced platelet aggregation and biosynthesis of Platelet Activating Factor&#xD;
      in healthy men.&#xD;
&#xD;
      Although a large number of studies have reported protective effect of wine against&#xD;
      atherosclerosis in healthy people there are few data about the effect of long-term moderate&#xD;
      wine consumption in population with CVD. Therefore, the aim of this randomized, intervention&#xD;
      clinical study, with control group was to report the effects of regular light to moderate&#xD;
      wine consumption on cardiovascular biomarkers in people with CVD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study was a randomized, controlled, three-arm parallel intervention study, designed to&#xD;
      evaluate if the light to moderate wine consumption could modulate thrombosis and&#xD;
      inflammation, in patients with cardiovascular disease. The study was carried out in&#xD;
      accordance with the guidelines laid down in the Declaration of Helsinki (1989) of the World&#xD;
      Medical Association and was approved by the Bioethics Committee of Harokopio University.&#xD;
      Seventy one men patients with cardiovascular disease were initially recruited to participate&#xD;
      in the study. The recruitment took place in several hospitals of Athens in Greece under the&#xD;
      supervisor of corresponding cardiologist. Finally 64 met the inclusion criteria. Prior to&#xD;
      intervention all participants signed an informed consent All volunteers followed an initial&#xD;
      15 days wash-out period, abstaining from alcohol; then, they randomly assigned to one of the&#xD;
      three intervention groups. The randomization code was prepared by a staff member who was not&#xD;
      involved in running the trial, by using computer-generated random numbers. Subjects&#xD;
      instructed to follow their usual diet and not change their medication during the study. In&#xD;
      Group A (control group), participants consumed no alcohol, in Group B (ethanol group)&#xD;
      participants consumed 69 mL of tsipouro with 38% alcohol and participants in Group C consumed&#xD;
      200ml of red wine (Cabernet Sauvignon 13.5% alcohol vol.). The ethanol that was consumed in&#xD;
      the last two groups was equal at 27gr of ethanol per day and alcoholic beverage was consumed&#xD;
      along with the meal (lunch or dinner). Finally, 57 participants completed the study, in&#xD;
      particular 20 in Group A, 16 in Group B and 21 in Group C. Intervention lasted two months and&#xD;
      biological samples (blood, urine) were collected at the beginning (0 week), in the middle (4&#xD;
      week) and in the end (8 week) of each intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2013</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">June 2018</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect on platelet aggregation against PAF</measure>
    <time_frame>Changes between baseline, 4 and 8 weeks.</time_frame>
    <description>% Change of EC50 value of platelet aggregation against PAF</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect on platelet aggregation against ADP</measure>
    <time_frame>Changes between baseline, 4 and 8 weeks.</time_frame>
    <description>% Change of EC50 value of platelet aggregation against ADP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect on platelet aggregation against collagen</measure>
    <time_frame>Changes between baseline, 4 and 8 weeks.</time_frame>
    <description>% Change of EC50 value of platelet aggregation against collagen</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect on inflammatory markers (activity of Lyso-PAF-AT)</measure>
    <time_frame>Changes between baseline, 4 and 8 weeks.</time_frame>
    <description>% Change in the activity of PAF biosynthetic enzyme Lyso-PAF AT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect on inflammatory markers (activity of PAF-CPT)</measure>
    <time_frame>Changes between baseline, 4 and 8 weeks.</time_frame>
    <description>% Change in the activity of PAF biosynthetic enzyme PAF-CPT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect on inflammatory markers (activity of PAF-AH)</measure>
    <time_frame>Changes between baseline, 4 and 8 weeks.</time_frame>
    <description>% Change in the activity of PAF degradation enzyme PAF-AH</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect on inflammatory markers (activity of LpPLA2)</measure>
    <time_frame>Changes between baseline, 4 and 8 weeks.</time_frame>
    <description>% Change in the activity of PAF degradation enzyme Lp-PLA2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect on inflammatory markers</measure>
    <time_frame>Changes between baseline, 4 and 8 weeks.</time_frame>
    <description>% Changes of Adiponectin, IL-6, CRP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cytokine secretion by PBMC</measure>
    <time_frame>Changes between baseline, 4 and 8 weeks.</time_frame>
    <description>Secretion of TNFa and IL-1β by PBMC under basal and inflammatory (LPS-induced) conditions at 4 and 24h incubation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect on endothelial function markers</measure>
    <time_frame>Changes between baseline, 4 and 8 weeks.</time_frame>
    <description>% Changes of VCAM, P-selectin.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect on biochemical indices</measure>
    <time_frame>Changes between baseline, 4 and 8 weeks.</time_frame>
    <description>% Changes of Total cholesterol, LDL-chol, HDL-chol, triacylglycerols, uric acid, glucose, insulin, SGOT/AST, SGPT/ALT, γ-GT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect on oxidative stress markers</measure>
    <time_frame>Changes between baseline, 4 and 8 weeks.</time_frame>
    <description>% Changes of TBARS, Lag time, GPx</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>Red Wine group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants of this group consumed 200ml of red wine along with a meal (lunch or dinner) every day for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ethanol group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants of this group consumed 69mL of tsipouro along with a meal (lunch or dinner) every day for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants of this group consumed no alcohol along with a meal (lunch or dinner) every day for 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cabernet Sauvignon</intervention_name>
    <description>Cabernet Sauvignon is a red wine from a greek company which contains 13.5% alcohol vol.</description>
    <arm_group_label>Red Wine group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tsipouro</intervention_name>
    <description>Tsipouro is a greek spirit which contains 38% alcohol vol</description>
    <arm_group_label>Ethanol group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The presence of Coronary Heart disease established by angiography or the presence of one of&#xD;
        the following:&#xD;
&#xD;
          1. positive stress test&#xD;
&#xD;
          2. positive myocardial perfusion scintigraphy with Thallium&#xD;
&#xD;
          3. positive triplex heart ultrasound with Dobutamine&#xD;
&#xD;
        If nothing of the criteria above existed then hospitalization because of myocardial&#xD;
        infarction or stroke.&#xD;
&#xD;
        Stable medication for at least 6 months.&#xD;
&#xD;
        Habit to drink 10-28gr of alcohol per week.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        History of any other inflammatory disease, diabetes, presence of cold or flu, acute&#xD;
        respiratory infection, dental problems and renal/hepatic diseases.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>37 Years</minimum_age>
    <maximum_age>82 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Nutrition-Dietetics, Harokopio University</name>
      <address>
        <city>Athens</city>
        <zip>17671</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Harokopio University</investigator_affiliation>
    <investigator_full_name>Elizabeth Fragopoulou</investigator_full_name>
    <investigator_title>Assistant Professor of Biological Chemistry</investigator_title>
  </responsible_party>
  <keyword>wine</keyword>
  <keyword>cardiovascular disease</keyword>
  <keyword>inflammatory biomarkers</keyword>
  <keyword>platelet aggregation</keyword>
  <keyword>Platelet Activating Factor</keyword>
  <keyword>ethanol</keyword>
  <keyword>PBMCs</keyword>
  <keyword>Wine microcontsituents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04438122
org study id: HarokopioU
nct id: NCT04438122
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Many epidemiological studies support that 20-30gr of alcohol consumption per day is related
      with lower risk for cardiovascular diseases, heart attack as well as mortality related to
      these diseases. Since the French paradox was reported, a number of experimental and clinical
      studies have demonstrated the protective effect of red wine compared to other alcoholic
      drinks on different pathways of the pathogenesis of atherosclerosis. The investigator's
      previous results revealed that wine contain micro-constituents that exert potent in vitro
      anti-platelet and anti-inflammatory actions. Also, the wine consumption along with a
      standardized meal reduced platelet aggregation and biosynthesis of Platelet Activating Factor
      in healthy men.

      Although a large number of studies have reported protective effect of wine against
      atherosclerosis in healthy people there are few data about the effect of long-term moderate
      wine consumption in population with CVD. Therefore, the aim of this randomized, intervention
      clinical study, with control group was to report the effects of regular light to moderate
      wine consumption on cardiovascular biomarkers in people with CVD.
The study was a randomized, controlled, three-arm parallel intervention study, designed to
      evaluate if the light to moderate wine consumption could modulate thrombosis and
      inflammation, in patients with cardiovascular disease. The study was carried out in
      accordance with the guidelines laid down in the Declaration of Helsinki (1989) of the World
      Medical Association and was approved by the Bioethics Committee of Harokopio University.
      Seventy one men patients with cardiovascular disease were initially recruited to participate
      in the study. The recruitment took place in several hospitals of Athens in Greece under the
      supervisor of corresponding cardiologist. Finally 64 met the inclusion criteria. Prior to
      intervention all participants signed an informed consent All volunteers followed an initial
      15 days wash-out period, abstaining from alcohol; then, they randomly assigned to one of the
      three intervention groups. The randomization code was prepared by a staff member who was not
      involved in running the trial, by using computer-generated random numbers. Subjects
      instructed to follow their usual diet and not change their medication during the study. In
      Group A (control group), participants consumed no alcohol, in Group B (ethanol group)
      participants consumed 69 mL of tsipouro with 38% alcohol and participants in Group C consumed
      200ml of red wine (Cabernet Sauvignon 13.5% alcohol vol.). The ethanol that was consumed in
      the last two groups was equal at 27gr of ethanol per day and alcoholic beverage was consumed
      along with the meal (lunch or dinner). Finally, 57 participants completed the study, in
      particular 20 in Group A, 16 in Group B and 21 in Group C. Intervention lasted two months and
      biological samples (blood, urine) were collected at the beginning (0 week), in the middle (4
      week) and in the end (8 week) of each intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Effect on platelet aggregation against PAF
time frame: Changes between baseline, 4 and 8 weeks.
description: % Change of EC50 value of platelet aggregation against PAF
measure: Effect on platelet aggregation against ADP
time frame: Changes between baseline, 4 and 8 weeks.
description: % Change of EC50 value of platelet aggregation against ADP
measure: Effect on platelet aggregation against collagen
time frame: Changes between baseline, 4 and 8 weeks.
description: % Change of EC50 value of platelet aggregation against collagen
measure: Effect on inflammatory markers (activity of Lyso-PAF-AT)
time frame: Changes between baseline, 4 and 8 weeks.
description: % Change in the activity of PAF biosynthetic enzyme Lyso-PAF AT
measure: Effect on inflammatory markers (activity of PAF-CPT)
time frame: Changes between baseline, 4 and 8 weeks.
description: % Change in the activity of PAF biosynthetic enzyme PAF-CPT
measure: Effect on inflammatory markers (activity of PAF-AH)
time frame: Changes between baseline, 4 and 8 weeks.
description: % Change in the activity of PAF degradation enzyme PAF-AH
measure: Effect on inflammatory markers (activity of LpPLA2)
time frame: Changes between baseline, 4 and 8 weeks.
description: % Change in the activity of PAF degradation enzyme Lp-PLA2
measure: Effect on inflammatory markers
time frame: Changes between baseline, 4 and 8 weeks.
description: % Changes of Adiponectin, IL-6, CRP
measure: Cytokine secretion by PBMC
time frame: Changes between baseline, 4 and 8 weeks.
description: Secretion of TNFa and IL-1β by PBMC under basal and inflammatory (LPS-induced) conditions at 4 and 24h incubation
measure: Effect on endothelial function markers
time frame: Changes between baseline, 4 and 8 weeks.
description: % Changes of VCAM, P-selectin.
measure: Effect on biochemical indices
time frame: Changes between baseline, 4 and 8 weeks.
description: % Changes of Total cholesterol, LDL-chol, HDL-chol, triacylglycerols, uric acid, glucose, insulin, SGOT/AST, SGPT/ALT, γ-GT
measure: Effect on oxidative stress markers
time frame: Changes between baseline, 4 and 8 weeks.
description: % Changes of TBARS, Lag time, GPx
arm group label: Red Wine group
arm group type: Active Comparator
description: Participants of this group consumed 200ml of red wine along with a meal (lunch or dinner) every day for 8 weeks.
arm group label: Ethanol group
arm group type: Active Comparator
description: Participants of this group consumed 69mL of tsipouro along with a meal (lunch or dinner) every day for 8 weeks.
arm group label: Control group
arm group type: No Intervention
description: Participants of this group consumed no alcohol along with a meal (lunch or dinner) every day for 8 weeks
intervention type: Other
intervention name: Cabernet Sauvignon
description: Cabernet Sauvignon is a red wine from a greek company which contains 13.5% alcohol vol.
arm group label: Red Wine group
intervention type: Other
intervention name: Tsipouro
description: Tsipouro is a greek spirit which contains 38% alcohol vol
arm group label: Ethanol group
criteria: 
gender: Male
minimum age: 37 Years
maximum age: 82 Years
healthy volunteers: No
facility: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: Harokopio University
investigator full name: Elizabeth Fragopoulou
investigator title: Assistant Professor of Biological Chemistry
mesh term: Cardiovascular Diseases
sharing ipd: No