<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/NCT01662232</url>
  </required_header>
  <id_info>
    <org_study_id>Char-EGCG-FMD</org_study_id>
    <nct_id>NCT01662232</nct_id>
  </id_info>
  <brief_title>Improvement of Endothelial Function by EGCG</brief_title>
  <official_title>The Role of EGCG in Different Application Forms on Flow-mediated Dilation in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cardiovascular diseases are a major cause of morbidity and mortality worldwide. Impaired&#xD;
      endothelial function (assessed as flow-mediated dilation) represents an early marker for&#xD;
      later cardiovascular events. Epidemiological and experimental studies suggest that&#xD;
      consumption of tea is associated with lower progression of atherosclerosis and reduced&#xD;
      cardiovascular mortality.&#xD;
&#xD;
      Tea contains high amounts of polyphenols with important biological activities. The green tea&#xD;
      catechin epigallocatechin-3-gallate (EGCG) is the most potent physiologically active compound&#xD;
      in vitro. However, little is known about its contribution to beneficial effects of tea in&#xD;
      vivo.&#xD;
&#xD;
      In this crossover study the impact of a single dose of EGCG applied in different forms (green&#xD;
      tea beverage, green tea extract and EGCG) on flow-mediated dilation is investigated in&#xD;
      healthy volunteers two hours after ingestion. The amount of EGCG (200 mg) corresponds to&#xD;
      appr. 0.5 L of green tea. The results of the study will elucidate the contribution of EGCG in&#xD;
      cardiovascular protective effects of green tea in vivo. The outcomes will provide insights&#xD;
      about the role of EGCG in different application forms to improvements of endothelial function&#xD;
      in humans.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Flow-mediated dilation of the arteria brachialis</measure>
    <time_frame>2 hours after ingestion</time_frame>
    <description>Change in flow-mediated dilation (in %) of the arteria brachialis after a single dose of 200 mg EGCG either as green tea beverage, green tea extract or EGCG is assessed by vascular ultrasound.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Agonist-induced platelet aggregation in vitro</measure>
    <time_frame>2 hours after ingestion</time_frame>
    <description>Blood is drawn two hours after consumption and the effects on in vitro agonist-induced platelet aggregation after a single dose of 200 mg EGCG either as green tea beverage, green tea extract or EGCG are measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determination of plasma tea polyphenol levels</measure>
    <time_frame>2 hours after ingestion</time_frame>
    <description>Blood is drawn two hours after consumption and plasma concentrations of tea polyphenols are measured after a single dose of 200 mg EGCG either as green tea beverage, green tea extract or EGCG by HPLC.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Green tea beverage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>200 mg EGCG as green tea beverage.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Green tea extract</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>200 mg EGCG as green tea extract and same volume water as for tea beverage.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Epigallocatechin-3-gallate (EGCG)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>200 mg EGCG and same volume water as for tea beverage.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (Water)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Same volume water as for all intervention arms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Green tea beverage</intervention_name>
    <arm_group_label>Green tea beverage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Green tea extract</intervention_name>
    <arm_group_label>Green tea extract</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>EGCG</intervention_name>
    <arm_group_label>Epigallocatechin-3-gallate (EGCG)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo (Water)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male healthy volunteers&#xD;
&#xD;
          -  20-50 years&#xD;
&#xD;
          -  BMI &lt; 27 kg/m2&#xD;
&#xD;
          -  Cholesterol &lt; 240 mg/dl&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Hypertension&#xD;
&#xD;
          -  Conditions with impaired endothelial function&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Regular drug use&#xD;
&#xD;
          -  Alcohol abuse&#xD;
&#xD;
          -  Regular tea drinkers&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mario Lorenz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Cardiology and Angiology, Campus Mitte, Charité University Medicine Berlin, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Cardiology and Angiology, Campus Mitte, Charité University Medicine Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>February 2, 2016</last_update_submitted>
  <last_update_submitted_qc>February 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Mario Lorenz, PhD</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Green tea</keyword>
  <keyword>EGCG</keyword>
  <keyword>Cardiovascular diseases</keyword>
  <keyword>Endothelial function</keyword>
  <keyword>Flow-mediated dilation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_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/NCT01662232
org study id: Char-EGCG-FMD
nct id: NCT01662232
lead sponsor: 
has dmc: No
Cardiovascular diseases are a major cause of morbidity and mortality worldwide. Impaired
      endothelial function (assessed as flow-mediated dilation) represents an early marker for
      later cardiovascular events. Epidemiological and experimental studies suggest that
      consumption of tea is associated with lower progression of atherosclerosis and reduced
      cardiovascular mortality.

      Tea contains high amounts of polyphenols with important biological activities. The green tea
      catechin epigallocatechin-3-gallate (EGCG) is the most potent physiologically active compound
      in vitro. However, little is known about its contribution to beneficial effects of tea in
      vivo.

      In this crossover study the impact of a single dose of EGCG applied in different forms (green
      tea beverage, green tea extract and EGCG) on flow-mediated dilation is investigated in
      healthy volunteers two hours after ingestion. The amount of EGCG (200 mg) corresponds to
      appr. 0.5 L of green tea. The results of the study will elucidate the contribution of EGCG in
      cardiovascular protective effects of green tea in vivo. The outcomes will provide insights
      about the role of EGCG in different application forms to improvements of endothelial function
      in humans.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Flow-mediated dilation of the arteria brachialis
time frame: 2 hours after ingestion
description: Change in flow-mediated dilation (in %) of the arteria brachialis after a single dose of 200 mg EGCG either as green tea beverage, green tea extract or EGCG is assessed by vascular ultrasound.
measure: Agonist-induced platelet aggregation in vitro
time frame: 2 hours after ingestion
description: Blood is drawn two hours after consumption and the effects on in vitro agonist-induced platelet aggregation after a single dose of 200 mg EGCG either as green tea beverage, green tea extract or EGCG are measured.
measure: Determination of plasma tea polyphenol levels
time frame: 2 hours after ingestion
description: Blood is drawn two hours after consumption and plasma concentrations of tea polyphenols are measured after a single dose of 200 mg EGCG either as green tea beverage, green tea extract or EGCG by HPLC.
arm group label: Green tea beverage
arm group type: Active Comparator
description: 200 mg EGCG as green tea beverage.
arm group label: Green tea extract
arm group type: Active Comparator
description: 200 mg EGCG as green tea extract and same volume water as for tea beverage.
arm group label: Epigallocatechin-3-gallate (EGCG)
arm group type: Active Comparator
description: 200 mg EGCG and same volume water as for tea beverage.
arm group label: Placebo (Water)
arm group type: Placebo Comparator
description: Same volume water as for all intervention arms.
intervention type: Dietary Supplement
intervention name: Green tea beverage
arm group label: Green tea beverage
intervention type: Dietary Supplement
intervention name: Green tea extract
arm group label: Green tea extract
intervention type: Dietary Supplement
intervention name: EGCG
arm group label: Epigallocatechin-3-gallate (EGCG)
intervention type: Other
intervention name: Placebo
arm group label: Placebo (Water)
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mario Lorenz, PhD
role: Principal Investigator
affiliation: Department of Cardiology and Angiology, Campus Mitte, Charité University Medicine Berlin, Germany
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Mario Lorenz, PhD
investigator title: PhD
mesh term: Cardiovascular Diseases