<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/NCT02259205</url>
  </required_header>
  <id_info>
    <org_study_id>11SYN-2-652</org_study_id>
    <secondary_id>HUA</secondary_id>
    <nct_id>NCT02259205</nct_id>
  </id_info>
  <brief_title>Cardio Protective Properties of a Yogurt Enriched With Bioactive Lipids of Olive Oil Products</brief_title>
  <official_title>Cardio Protective Properties of a Yogurt Enriched With Bioactive Lipids of Olive Oil Products</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Harokopio University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National and Kapodistrian University of Athens</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Competitiveness and Entrepreneurship (OPCE II), NRSF 2007-13</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Harokopio University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effectiveness of a yogurt enriched with bioactive lipids extracted&#xD;
      from olive mill waste in platelet aggregation and other inflammatory and oxidative stress&#xD;
      markers. The study will include three groups: the intervention group will receive the&#xD;
      enriched yogurt while the other two groups will serve as controls (plain yogurt and no yogurt&#xD;
      consumption).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiovascular diseases are the leading cause of mortality worldwide. Data from the&#xD;
      investigators research group indicate that platelet activating factor (PAF) is one of the&#xD;
      most important inflammatory factors and the main mediator of thrombosis during the formation&#xD;
      of atherosclerotic plaque. Thus, dietary interventions aimed at inhibition of PAF is of&#xD;
      particular importance in public health level. The aim of the study is to examine the efficacy&#xD;
      of administering in humans bioactive lipids extracted from olive mill waste (with proven in&#xD;
      vitro anti-thrombotic activity and in vivo anti-atherosclerotic properties in rabbits fed an&#xD;
      atherogenic diet) to inhibit the activity of PAF and other inflammatory mediators.&#xD;
&#xD;
      Bioactive lipids are isolated by standardized methodology of oil manufacture byproducts.&#xD;
      Preliminary studies have been done in animals to establish the safety of administration of&#xD;
      these compounds and to clarify the effective dosages of administration for inhibiting&#xD;
      formation of atherosclerotic plaques. The effectiveness of these compounds in humans will be&#xD;
      examined in a randomized, double-blind clinical trial in subjects aged 40-60 years, lasting&#xD;
      eight weeks. Supplementation with the bioactive lipids will be in the form of an enriched&#xD;
      yogurt provided daily. The study includes three groups: treatment group, where enriched&#xD;
      yogurt will be provided, plain yogurt treatment group and no consumption of yogurt group .&#xD;
      Parameters that will be assessed are the inhibition of platelet aggregation (with three&#xD;
      different stimuli, including PAF), lipid profile, inflammatory markers such as CRP, IL-6,&#xD;
      TNFa, and oxidative stress markers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">October 2015</completion_date>
  <primary_completion_date type="Anticipated">July 2015</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Platelet aggregation</measure>
    <time_frame>0 (baseline), end of 4th week and 8th week</time_frame>
    <description>The ability of platelets to aggregate will be measured in platelet rich plasma (PRP) of volunteers using PAF, thrombin and ADP as aggregating factor.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Blood lipid profile</measure>
    <time_frame>0 (baseline), end of 4th week and 8th week</time_frame>
    <description>Blood levels of cholesterol, LDL-cholesterol, HDL-cholesterol and triacylglycerols will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Glucose and Insulin</measure>
    <time_frame>0 (baseline), end of 4th week and 8th week</time_frame>
    <description>Blood levels of glucose and insulin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Gastro-intestinal symptoms</measure>
    <time_frame>0 (baseline), end of 4th week and 8th week</time_frame>
    <description>Gastro-intestinal symptoms and possible side effects from yogurt consumption will be assessed through validated questionnaires.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Dietary intake</measure>
    <time_frame>0 (baseline), end of 8th week</time_frame>
    <description>Dietary intake will be assessed through two dietary recalls and a food frequency questionnaire at each time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Oxidative stress</measure>
    <time_frame>0 (baseline), end of 4th week and 8th week</time_frame>
    <description>Ex vivo serum oxidation as a marker for lipid oxidation and protein carbonyls as a marker for protein oxidation will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Gut microbiota populations</measure>
    <time_frame>0 (baseline), end of 8th week</time_frame>
    <description>the populations of lactobacilli, bifidobacteria and Clostridium histolyticum group will be estimated by real-time PCR using genus specific primers. Furthermore, the metabolic products of the gut microorganisms will be evaluated by measuring the short chain fatty acids profile in fecal samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Inflammation-related markers</measure>
    <time_frame>0 (baseline), end of 4th week and 8th week</time_frame>
    <description>C-reactive protein (CRP), IL-6, TNFa, IL-10 levels in fasting blood samples.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Enriched Yogurt</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>150 g yogurt enriched with approximately 0.5 g bioactive lipids extract from olive oil mill provided daily for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Plain Yogurt</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>150 g not enriched yogurt provided daily for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No yogurt consumption</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Enriched Yogurt</intervention_name>
    <description>150 g yogurt enriched with bioactive lipids extract from olive oil mill will be provided daily for 8 weeks</description>
    <arm_group_label>Enriched Yogurt</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Plain Yogurt</intervention_name>
    <description>150 g plain yogurt will be provided daily for 8 weeks</description>
    <arm_group_label>Plain Yogurt</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All individuals, aged 40-60 years, without any of the exclusion criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any anti-inflammatory medication&#xD;
&#xD;
          -  Hyper-lipidemic medications&#xD;
&#xD;
          -  Use of antibiotics within two months from study entry&#xD;
&#xD;
          -  Pregnancy or childbirth in the previous year&#xD;
&#xD;
          -  Intake of any nutritional supplement&#xD;
&#xD;
          -  Any serious dental, respiratory, liver, kidney, gastrointestinal disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Smaragdi Antonopoulou, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Harokopio University, Department of Nutrition and Dietetics</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elizabeth Frafopoulou, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Harokopio University, Department of Nutrition and Dietetics</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tzortzis Nomikos, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Harokopio University, Department of Nutrition and Dietetics</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Smaragdi Antonopoulou, PhD</last_name>
    <phone>+302109549100</phone>
    <phone_ext>230</phone_ext>
    <email>antonop@hua.gr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tzortzis Nomikos, PhD</last_name>
    <phone>+302109549100</phone>
    <phone_ext>305</phone_ext>
    <email>tnomikos@hua.gr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Harokopio University, Department of Nutrition and Dietetics</name>
      <address>
        <city>Athens</city>
        <state>Attiki</state>
        <zip>17671</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>George Milias, PhD</last_name>
      <phone>+302109549100</phone>
      <phone_ext>181</phone_ext>
      <email>gmilias@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Costas Anastasiou, PhD</last_name>
      <phone>+302109549100</phone>
      <phone_ext>181</phone_ext>
      <email>acostas@hua.gr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>April 7, 2015</last_update_submitted>
  <last_update_submitted_qc>April 7, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Harokopio University</investigator_affiliation>
    <investigator_full_name>Smaragdi Antonopoulou</investigator_full_name>
    <investigator_title>Professor in Biochemistry</investigator_title>
  </responsible_party>
  <keyword>platelet activating factor</keyword>
  <keyword>inflammatory markers</keyword>
  <keyword>yogurt</keyword>
  <keyword>olive oil</keyword>
  <keyword>platelet aggregation</keyword>
  <keyword>oxidative stress</keyword>
  <keyword>endothelial damage</keyword>
  <keyword>bioactive lipids</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/NCT02259205
org study id: 11SYN-2-652
secondary id: HUA
nct id: NCT02259205
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This study evaluates the effectiveness of a yogurt enriched with bioactive lipids extracted
      from olive mill waste in platelet aggregation and other inflammatory and oxidative stress
      markers. The study will include three groups: the intervention group will receive the
      enriched yogurt while the other two groups will serve as controls (plain yogurt and no yogurt
      consumption).
Cardiovascular diseases are the leading cause of mortality worldwide. Data from the
      investigators research group indicate that platelet activating factor (PAF) is one of the
      most important inflammatory factors and the main mediator of thrombosis during the formation
      of atherosclerotic plaque. Thus, dietary interventions aimed at inhibition of PAF is of
      particular importance in public health level. The aim of the study is to examine the efficacy
      of administering in humans bioactive lipids extracted from olive mill waste (with proven in
      vitro anti-thrombotic activity and in vivo anti-atherosclerotic properties in rabbits fed an
      atherogenic diet) to inhibit the activity of PAF and other inflammatory mediators.

      Bioactive lipids are isolated by standardized methodology of oil manufacture byproducts.
      Preliminary studies have been done in animals to establish the safety of administration of
      these compounds and to clarify the effective dosages of administration for inhibiting
      formation of atherosclerotic plaques. The effectiveness of these compounds in humans will be
      examined in a randomized, double-blind clinical trial in subjects aged 40-60 years, lasting
      eight weeks. Supplementation with the bioactive lipids will be in the form of an enriched
      yogurt provided daily. The study includes three groups: treatment group, where enriched
      yogurt will be provided, plain yogurt treatment group and no consumption of yogurt group .
      Parameters that will be assessed are the inhibition of platelet aggregation (with three
      different stimuli, including PAF), lipid profile, inflammatory markers such as CRP, IL-6,
      TNFa, and oxidative stress markers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Changes in Platelet aggregation
time frame: 0 (baseline), end of 4th week and 8th week
description: The ability of platelets to aggregate will be measured in platelet rich plasma (PRP) of volunteers using PAF, thrombin and ADP as aggregating factor.
measure: Changes in Blood lipid profile
time frame: 0 (baseline), end of 4th week and 8th week
description: Blood levels of cholesterol, LDL-cholesterol, HDL-cholesterol and triacylglycerols will be measured.
measure: Changes in Glucose and Insulin
time frame: 0 (baseline), end of 4th week and 8th week
description: Blood levels of glucose and insulin
measure: Changes in Gastro-intestinal symptoms
time frame: 0 (baseline), end of 4th week and 8th week
description: Gastro-intestinal symptoms and possible side effects from yogurt consumption will be assessed through validated questionnaires.
measure: Change in Dietary intake
time frame: 0 (baseline), end of 8th week
description: Dietary intake will be assessed through two dietary recalls and a food frequency questionnaire at each time point.
measure: Changes in Oxidative stress
time frame: 0 (baseline), end of 4th week and 8th week
description: Ex vivo serum oxidation as a marker for lipid oxidation and protein carbonyls as a marker for protein oxidation will be measured.
measure: Changes in Gut microbiota populations
time frame: 0 (baseline), end of 8th week
description: the populations of lactobacilli, bifidobacteria and Clostridium histolyticum group will be estimated by real-time PCR using genus specific primers. Furthermore, the metabolic products of the gut microorganisms will be evaluated by measuring the short chain fatty acids profile in fecal samples.
measure: Changes in Inflammation-related markers
time frame: 0 (baseline), end of 4th week and 8th week
description: C-reactive protein (CRP), IL-6, TNFa, IL-10 levels in fasting blood samples.
arm group label: Enriched Yogurt
arm group type: Experimental
description: 150 g yogurt enriched with approximately 0.5 g bioactive lipids extract from olive oil mill provided daily for 8 weeks
arm group label: Plain Yogurt
arm group type: Placebo Comparator
description: 150 g not enriched yogurt provided daily for 8 weeks
arm group label: Control
arm group type: No Intervention
description: No yogurt consumption
intervention type: Other
intervention name: Enriched Yogurt
description: 150 g yogurt enriched with bioactive lipids extract from olive oil mill will be provided daily for 8 weeks
arm group label: Enriched Yogurt
intervention type: Other
intervention name: Plain Yogurt
description: 150 g plain yogurt will be provided daily for 8 weeks
arm group label: Plain Yogurt
criteria: 
gender: All
minimum age: 40 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Smaragdi Antonopoulou, PhD
role: Principal Investigator
affiliation: Harokopio University, Department of Nutrition and Dietetics
last name: Elizabeth Frafopoulou, PhD
role: Study Chair
affiliation: Harokopio University, Department of Nutrition and Dietetics
last name: Tzortzis Nomikos, PhD
role: Study Chair
affiliation: Harokopio University, Department of Nutrition and Dietetics
last name: Smaragdi Antonopoulou, PhD
phone: +302109549100
phone ext: 230
email: antonop@hua.gr
last name: Tzortzis Nomikos, PhD
phone: +302109549100
phone ext: 305
email: tnomikos@hua.gr
facility: 
status: Recruiting
contact: 
contact backup: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: Harokopio University
investigator full name: Smaragdi Antonopoulou
investigator title: Professor in Biochemistry
mesh term: Cardiovascular Diseases