<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/NCT02990637</url>
  </required_header>
  <id_info>
    <org_study_id>163004</org_study_id>
    <nct_id>NCT02990637</nct_id>
  </id_info>
  <brief_title>The Effect of Olive Leaf Extract Administration on Cardiovascular Health</brief_title>
  <official_title>The Effect of Olive Leaf Extract Administration on Cardiovascular Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effects of daily supplementation of OLECOL&#xD;
      for a period of 8 weeks on cardiovascular risk markers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2016</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</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>Blood lipid profile</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lipid peroxidation</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose metabolism</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic and diastolic blood pressure</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Overweight and Obesity</condition>
  <condition>Elevated Cholesterol</condition>
  <arm_group>
    <arm_group_label>OLECOL</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Olive leaf extract</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Maltodextrin</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>OLECOL</intervention_name>
    <description>Olive leaf extract</description>
    <arm_group_label>OLECOL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Maltodextrin</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy individuals&#xD;
&#xD;
          -  Age between 18 and 70 years&#xD;
&#xD;
          -  Total cholesterol levels ≥ 5.0 mmol/L&#xD;
&#xD;
          -  BMI 25-35 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of severe cardiovascular, respiratory, urogenital, gastrointestinal/hepatic,&#xD;
             hematological/immunologic, HEENT (head, ears, eyes, nose, throat).&#xD;
             Dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine,&#xD;
             neurological diseases, allergy, major surgery and /or laboratory assessments that&#xD;
             might limit participation in or completion of the study protocol.&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Use of medication that might have influence on endpoints (e.g. cholesterol lowering&#xD;
             medication, hypertension medication)&#xD;
&#xD;
          -  Administration of investigational drugs or participation in any scientific&#xD;
             intervention study which may interfere with this study in the 180 days prior to the&#xD;
             study&#xD;
&#xD;
          -  Use of antibiotics in the 30 days prior to the start of the study&#xD;
&#xD;
          -  Use of antioxidants, minerals and vitamin supplements available in pharmacies,&#xD;
             drugstores, food markets or in alternative medicine&#xD;
&#xD;
          -  Pregnancy, lactation&#xD;
&#xD;
          -  Abuse of products (&gt; 20 alcoholic consumptions per week and drugs)&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Weight gain or loss (&gt; 3 kg in previous 3 months)&#xD;
&#xD;
          -  High physical activity (&gt;4.5 hours of running/week)&#xD;
&#xD;
          -  History of any side effects towards intake of olives&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ad Masclee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maastricht University Medical Center</name>
      <address>
        <city>Maastricht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>May 9, 2017</last_update_submitted>
  <last_update_submitted_qc>May 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Maastricht University Medical Center</investigator_affiliation>
    <investigator_full_name>Yala Stevens</investigator_full_name>
    <investigator_title>MSc.</investigator_title>
  </responsible_party>
  <keyword>Olive leaf extract</keyword>
  <keyword>Cardiovascular health</keyword>
  <keyword>Cholesterol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Hypercholesterolemia</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/NCT02990637
org study id: 163004
nct id: NCT02990637
lead sponsor: 
The purpose of this study is to investigate the effects of daily supplementation of OLECOL
      for a period of 8 weeks on cardiovascular risk markers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Blood lipid profile
time frame: 8 weeks
measure: Lipid peroxidation
time frame: 8 weeks
measure: Glucose metabolism
time frame: 8 weeks
measure: Systolic and diastolic blood pressure
time frame: 8 weeks
arm group label: OLECOL
arm group type: Active Comparator
description: Olive leaf extract
arm group label: Placebo
arm group type: Placebo Comparator
description: Maltodextrin
intervention type: Dietary Supplement
intervention name: OLECOL
description: Olive leaf extract
arm group label: OLECOL
intervention type: Dietary Supplement
intervention name: Placebo
description: Maltodextrin
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ad Masclee, MD
role: Principal Investigator
affiliation: Maastricht University Medical Center
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Maastricht University Medical Center
investigator full name: Yala Stevens
investigator title: MSc.
mesh term: Overweight
mesh term: Hypercholesterolemia