<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/NCT04436263</url>
  </required_header>
  <id_info>
    <org_study_id>HarokopioU_anti-PAF extract</org_study_id>
    <nct_id>NCT04436263</nct_id>
  </id_info>
  <brief_title>Cardioprotective Properties of Natural Anti-Platelet Activating Factor Extract From Winery By-products in Healthy Women</brief_title>
  <acronym>NAPE</acronym>
  <official_title>Investigation of in Vivo Anti-inflammatory and Anti-platelet Mechanisms of Natural Extract by Modulating PAF Metabolism and Actions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Harokopio University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Harokopio University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the anti-platelet and anti-inflammatory&#xD;
      properties of a winery by-products extract as well as to detect extract compounds and their&#xD;
      metabolites in biological fluids. The study is a randomized, double-blind, crossover, placebo&#xD;
      controlled postprandial study in healthy women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The well-known cardioprotective and metabolic effects of wine consumption are mainly&#xD;
      attributed to its micro-constituents. Grape pomace (GP) is a by-product of the winemaking&#xD;
      process and consists mainly of skins and seeds. Winery by-products are a cheap and rich&#xD;
      source of similar-to wine micro-constituents, which can be used either to enrich other foods&#xD;
      or to be included in food supplements targeting the prevention or partially the therapy of&#xD;
      cardiovascular diseases.In this line, our previous results revealed the potent in vitro&#xD;
      anti-platelet effects of a specific ethanol-water extract rich in Platelet-Activating Factor&#xD;
      inhibitors from winery by-products.&#xD;
&#xD;
      The purpose of this study is to investigate the in vivo anti-platelet and anti-inflammatory&#xD;
      properties of the specific winery by-products extract as well as to detect the extract&#xD;
      compounds and their metabolites in biological fluids.&#xD;
&#xD;
      Therefore a randomized double-blind, crossover, placebo controlled postprandial study in&#xD;
      healthy women will be implemented. For this purpose, 15 healthy women will participate in the&#xD;
      protocol. The two daily trials will take place during specific days based on their menstrual&#xD;
      cycle. Three days before each blood collection the volunteers will be instructed to abstain&#xD;
      from food and beverages rich in phenolic compounds and their dietary intake will be recorded&#xD;
      (three 24h recalls and one food frequency questionnaire). The blood collections will be&#xD;
      carried out after 8h fasting. At trial day, the volunteers will bring the first morning urine&#xD;
      sample and anthropometric measurements will take place (weight, height, waist/hip&#xD;
      circumference, bioelectrical impedance). Then a venous catheter will be placed and after 10&#xD;
      minutes the fasting blood will be collected. Volunteers will proceed to the consumption of a&#xD;
      standardized meal (1131 kcal, 19.7% carbohydrates, 11.2% protein, 66.7% fat) along with the&#xD;
      capsules (study extract or placebo). The type of the capsules consumed (study extract or&#xD;
      placebo) will be randomized and blind during the two intervention days for both volunteers&#xD;
      and investigators. Blood will be drown after the meal consumption and for the next 6h (every&#xD;
      30minutes for the first 4h and every 1h for the next 2h). Serum, plasma, platelet-rich&#xD;
      plasma, leukocyte-rich plasma and urine samples will be isolated at certain time points&#xD;
      during trial days so that the anti-platelet, anti-inflammatory and antioxidant effects of the&#xD;
      study extract can be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 20, 2020</start_date>
  <completion_date type="Anticipated">June 20, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 20, 2021</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect on platelet aggregation</measure>
    <time_frame>Change between timepoints (before meal consumption, 30min, 90min, 150min, 210min, 300min) of the 6hour trial and between the two different interventions</time_frame>
    <description>% Change of EC50 value of platelet aggregation against PAF</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect on platelet aggregation</measure>
    <time_frame>Change between timepoints (before meal consumption, 30min, 90min, 150min, 210min, 300min) of the 6hour trial and between the two different interventions</time_frame>
    <description>% Change of EC50 value of platelet aggregation against ADP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect on platelet aggregation</measure>
    <time_frame>Change between timepoints (before meal consumption, 30min, 90min, 150min, 210min, 300min) of the 6hour trial and between the two different interventions</time_frame>
    <description>% Change of EC50 value of platelet aggregation against Collagen</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect on inflammatory markers</measure>
    <time_frame>Change between timepoints (before meal consumption, 60min, 120min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions</time_frame>
    <description>Change in PAF biosynthetic enzymes activity (lyso-PAF AT)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect on inflammatory markers</measure>
    <time_frame>Change between timepoints (before meal consumption, 60min, 120min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions</time_frame>
    <description>Change in PAF biosynthetic enzymes activity (PAF-CPT)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect on inflammatory markers</measure>
    <time_frame>Change between timepoints (before meal consumption, 60min, 120min, 180min, 240min, 360min) of the 6hour trial and between the two different interventions</time_frame>
    <description>Change in PAF levels Change in PAF degradation enzyme activity (Lp-PLA2) Change in PAF levels IL6</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect on inflammatory markers</measure>
    <time_frame>Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions</time_frame>
    <description>Change in PAF degradation enzyme activity (Lp-PLA2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect on inflammatory markers</measure>
    <time_frame>Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions</time_frame>
    <description>IL-6</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect on classical biochemical markers</measure>
    <time_frame>Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions</time_frame>
    <description>Total serum cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect on classical biochemical markers</measure>
    <time_frame>Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions</time_frame>
    <description>LDL-cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect on classical biochemical markers</measure>
    <time_frame>Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions</time_frame>
    <description>HDL-cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect on classical biochemical markers</measure>
    <time_frame>Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions</time_frame>
    <description>TAG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect on classical biochemical markers</measure>
    <time_frame>Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions</time_frame>
    <description>uric acid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect on classical biochemical markers</measure>
    <time_frame>Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions</time_frame>
    <description>Glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect on classical biochemical markers</measure>
    <time_frame>Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions</time_frame>
    <description>Insulin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Detection and estimation of extract compounds metabolites</measure>
    <time_frame>Change between timepoints (before meal consumption, 60min, 120min, 240min, 360min) of the 6hour trial and between the two different interventions</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Platelet Aggregation and Inflammation</condition>
  <arm_group>
    <arm_group_label>Supplement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ethanol-water extract of winery by-products</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Maltodextrin-based placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Supplement</intervention_name>
    <description>A sufficient quantity of the winery by-products will be extracted on an industrial scale and capsules will be produced, each one containing 110mg of phenolic compounds (gallic acid equivalents).Volunteers will consume 6 capsules along with a standardized meal (1131 kcal, 19.7% carbohydrates, 11.2% protein, 66.7% fat) and blood will be drown before the meal consumption and at specific time points for the next 6h</description>
    <arm_group_label>Supplement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>A look-alike placebo containing maltodextrin will be prepared.Volunteers will consume 6 capsules along with a standardized meal (1131 kcal, 19.7% carbohydrates, 11.2% protein, 66.7% fat) and blood will be drown before the meal consumption and at specific time points for the next 6h</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  Females&#xD;
&#xD;
          -  BMI: 22-32 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Systematic medication&#xD;
&#xD;
          -  Chronic disease conditions&#xD;
&#xD;
          -  Specific dietary conditions (vegeterian, vegan...)&#xD;
&#xD;
          -  Eating disorders&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Elizabeth Fragopoulou, PhD</last_name>
    <phone>2109549249</phone>
    <phone_ext>0030</phone_ext>
    <email>efragop@hua.gr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Nutrition-Dietetics, Harokopio University</name>
      <address>
        <city>Athens</city>
        <zip>17671</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Fragopoulou, PhD</last_name>
      <phone>2109549249</phone>
      <phone_ext>0030</phone_ext>
      <email>efragop@hua.gr</email>
    </contact>
    <investigator>
      <last_name>Elizabeth Fragopoulou, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 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 in Biological Chemistry</investigator_title>
  </responsible_party>
  <keyword>winery by-products</keyword>
  <keyword>natural extract</keyword>
  <keyword>postprandial study</keyword>
  <keyword>platelet aggregation</keyword>
  <keyword>anti-inflammatory</keyword>
  <keyword>healthy women</keyword>
  <keyword>Platelet-activating factor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</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/NCT04436263
org study id: HarokopioU_anti-PAF extract
nct id: NCT04436263
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the anti-platelet and anti-inflammatory
      properties of a winery by-products extract as well as to detect extract compounds and their
      metabolites in biological fluids. The study is a randomized, double-blind, crossover, placebo
      controlled postprandial study in healthy women.
The well-known cardioprotective and metabolic effects of wine consumption are mainly
      attributed to its micro-constituents. Grape pomace (GP) is a by-product of the winemaking
      process and consists mainly of skins and seeds. Winery by-products are a cheap and rich
      source of similar-to wine micro-constituents, which can be used either to enrich other foods
      or to be included in food supplements targeting the prevention or partially the therapy of
      cardiovascular diseases.In this line, our previous results revealed the potent in vitro
      anti-platelet effects of a specific ethanol-water extract rich in Platelet-Activating Factor
      inhibitors from winery by-products.

      The purpose of this study is to investigate the in vivo anti-platelet and anti-inflammatory
      properties of the specific winery by-products extract as well as to detect the extract
      compounds and their metabolites in biological fluids.

      Therefore a randomized double-blind, crossover, placebo controlled postprandial study in
      healthy women will be implemented. For this purpose, 15 healthy women will participate in the
      protocol. The two daily trials will take place during specific days based on their menstrual
      cycle. Three days before each blood collection the volunteers will be instructed to abstain
      from food and beverages rich in phenolic compounds and their dietary intake will be recorded
      (three 24h recalls and one food frequency questionnaire). The blood collections will be
      carried out after 8h fasting. At trial day, the volunteers will bring the first morning urine
      sample and anthropometric measurements will take place (weight, height, waist/hip
      circumference, bioelectrical impedance). Then a venous catheter will be placed and after 10
      minutes the fasting blood will be collected. Volunteers will proceed to the consumption of a
      standardized meal (1131 kcal, 19.7% carbohydrates, 11.2% protein, 66.7% fat) along with the
      capsules (study extract or placebo). The type of the capsules consumed (study extract or
      placebo) will be randomized and blind during the two intervention days for both volunteers
      and investigators. Blood will be drown after the meal consumption and for the next 6h (every
      30minutes for the first 4h and every 1h for the next 2h). Serum, plasma, platelet-rich
      plasma, leukocyte-rich plasma and urine samples will be isolated at certain time points
      during trial days so that the anti-platelet, anti-inflammatory and antioxidant effects of the
      study extract can be evaluated.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Effect on platelet aggregation
time frame: Change between timepoints (before meal consumption, 30min, 90min, 150min, 210min, 300min) of the 6hour trial and between the two different interventions
description: % Change of EC50 value of platelet aggregation against PAF
measure: Effect on platelet aggregation
time frame: Change between timepoints (before meal consumption, 30min, 90min, 150min, 210min, 300min) of the 6hour trial and between the two different interventions
description: % Change of EC50 value of platelet aggregation against ADP
measure: Effect on platelet aggregation
time frame: Change between timepoints (before meal consumption, 30min, 90min, 150min, 210min, 300min) of the 6hour trial and between the two different interventions
description: % Change of EC50 value of platelet aggregation against Collagen
measure: Effect on inflammatory markers
time frame: Change between timepoints (before meal consumption, 60min, 120min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
description: Change in PAF biosynthetic enzymes activity (lyso-PAF AT)
measure: Effect on inflammatory markers
time frame: Change between timepoints (before meal consumption, 60min, 120min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
description: Change in PAF biosynthetic enzymes activity (PAF-CPT)
measure: Effect on inflammatory markers
time frame: Change between timepoints (before meal consumption, 60min, 120min, 180min, 240min, 360min) of the 6hour trial and between the two different interventions
description: Change in PAF levels Change in PAF degradation enzyme activity (Lp-PLA2) Change in PAF levels IL6
measure: Effect on inflammatory markers
time frame: Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
description: Change in PAF degradation enzyme activity (Lp-PLA2)
measure: Effect on inflammatory markers
time frame: Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
description: IL-6
measure: Effect on classical biochemical markers
time frame: Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
description: Total serum cholesterol
measure: Effect on classical biochemical markers
time frame: Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
description: LDL-cholesterol
measure: Effect on classical biochemical markers
time frame: Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
description: HDL-cholesterol
measure: Effect on classical biochemical markers
time frame: Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
description: TAG
measure: Effect on classical biochemical markers
time frame: Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
description: uric acid
measure: Effect on classical biochemical markers
time frame: Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
description: Glucose
measure: Effect on classical biochemical markers
time frame: Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
description: Insulin
measure: Detection and estimation of extract compounds metabolites
time frame: Change between timepoints (before meal consumption, 60min, 120min, 240min, 360min) of the 6hour trial and between the two different interventions
arm group label: Supplement
arm group type: Experimental
description: Ethanol-water extract of winery by-products
arm group label: Placebo
arm group type: Placebo Comparator
description: Maltodextrin-based placebo
intervention type: Behavioral
intervention name: Supplement
description: A sufficient quantity of the winery by-products will be extracted on an industrial scale and capsules will be produced, each one containing 110mg of phenolic compounds (gallic acid equivalents).Volunteers will consume 6 capsules along with a standardized meal (1131 kcal, 19.7% carbohydrates, 11.2% protein, 66.7% fat) and blood will be drown before the meal consumption and at specific time points for the next 6h
arm group label: Supplement
intervention type: Behavioral
intervention name: Placebo
description: A look-alike placebo containing maltodextrin will be prepared.Volunteers will consume 6 capsules along with a standardized meal (1131 kcal, 19.7% carbohydrates, 11.2% protein, 66.7% fat) and blood will be drown before the meal consumption and at specific time points for the next 6h
arm group label: Placebo
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Elizabeth Fragopoulou, PhD
phone: 2109549249
phone ext: 0030
email: efragop@hua.gr
facility: 
status: Recruiting
contact: 
investigator: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: Harokopio University
investigator full name: Elizabeth Fragopoulou
investigator title: Assistant Professor in Biological Chemistry
mesh term: Inflammation
sharing ipd: No