<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/NCT03796780</url>
  </required_header>
  <id_info>
    <org_study_id>425</org_study_id>
    <nct_id>NCT03796780</nct_id>
  </id_info>
  <brief_title>Comparison of Extra-Virgin and Refined Olive Oil on Some Cardiovascular Risk Factors</brief_title>
  <official_title>Comparison of Effects of Extra-virgin and Refined Olive Oil Consumption on Plasma Lipids and Inflammatory Markers in Patients Undergoing Coronary Angiography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Javad Nasrollahzadeh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shahid Beheshti University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shahid Beheshti 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>
      Consumption of extra-virgin olive oil has beneficial effects on cardiovascular risk factors.&#xD;
      The purpose of this study is to compare the effects of extra-virgin olive oil and refined&#xD;
      olive oil, in adjunct to conventional medical treatment, in improving liver enzymes, plasma&#xD;
      lipid profile and inflammatory markers in patients with cardiovascular risk factors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized placebo controlled clinical trial will be conducted in Rajaie Cardiovascular&#xD;
      Center in Tehran, Iran. After review of the inclusion and exclusion criteria and explanation&#xD;
      of the design of the study, written consent form will be completed. The participants are 40&#xD;
      eligible patients, aged 20-75 years. Intervention group will be received 25 mL/d extra-virgin&#xD;
      olive oil and control group will be received 25 mL/d refined olive oil for 6 weeks. Fasting&#xD;
      blood sample will be taken to measure lipid profile, liver enzymes and inflammatory markers&#xD;
      (Interleukine-6 [IL-6] and Interleukine-10 [IL-10] and C-Reactive Protein [CRP]).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">October 1, 2019</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Interleukin-6 (IL-6)</measure>
    <time_frame>6 week</time_frame>
    <description>change in plasma level of interleukin-6 (IL-6) in pg/mL from baseline at week-6</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>plasma lipid profile</measure>
    <time_frame>6 week</time_frame>
    <description>change in plasma level of lipoproteins in mg/dL from baseline at 6 week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma liver enzymes (SGOT &amp; SGPT)</measure>
    <time_frame>6 week</time_frame>
    <description>change in plasma level of liver enzymes (SGOT &amp; SGPT) in mg/dL from baseline at 6 week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interleukin-10 (IL-10)</measure>
    <time_frame>6 week</time_frame>
    <description>Change in plasma level of interleukin-10 (IL-10) in pg/mL at baseline and week-6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C reactive protein (CRP)</measure>
    <time_frame>6 week</time_frame>
    <description>Change in plasma level of C reactive protein (CRP) in mg/dL from baseline and week-6</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Cardiovascular Risk Factor</condition>
  <arm_group>
    <arm_group_label>Extra-Virgin Olive Oil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Daily consumption of 25 mL Extra-Virgin Olive Oil for 6 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Refined Olive Oil</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Daily consumption of 25 mL Refined Olive Oil for 6 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Extra-Virgin Olive Oil</intervention_name>
    <description>Daily consumption of 25 mL Extra-Virgin Olive Oil in adjunct to medical treatment for 6 weeks</description>
    <arm_group_label>Extra-Virgin Olive Oil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Refined Olive Oil</intervention_name>
    <description>Daily consumption of 25 mL Refined Olive Oil in adjunct to medical treatment for 6 weeks</description>
    <arm_group_label>Refined Olive Oil</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. patients with at least one of the cardiovascular risk factors (hypertension,&#xD;
             hyperlipidemia, diabetes mellitus) candidate for angiography&#xD;
&#xD;
          2. willing to participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Continuous consumption of any supplement with anti-inflammatory or antioxidant&#xD;
             properties such as Omega-3, vitamin E, vitamin C and Selenium in last month&#xD;
&#xD;
          2. َChronic kidney disease stage 5&#xD;
&#xD;
          3. Any change in disease treatment plan such as change in type and dose of lipid lowering&#xD;
             drugs or surgical operation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Javad Nasrollahzadeh, Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rajaei Cardiovascular, Medical &amp; Research Center</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>December 29, 2018</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>December 7, 2019</last_update_submitted>
  <last_update_submitted_qc>December 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shahid Beheshti University</investigator_affiliation>
    <investigator_full_name>Javad Nasrollahzadeh</investigator_full_name>
    <investigator_title>Investigator in Clinical Nutrition</investigator_title>
  </responsible_party>
  <!-- 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/NCT03796780
org study id: 425
nct id: NCT03796780
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Consumption of extra-virgin olive oil has beneficial effects on cardiovascular risk factors.
      The purpose of this study is to compare the effects of extra-virgin olive oil and refined
      olive oil, in adjunct to conventional medical treatment, in improving liver enzymes, plasma
      lipid profile and inflammatory markers in patients with cardiovascular risk factors.
A randomized placebo controlled clinical trial will be conducted in Rajaie Cardiovascular
      Center in Tehran, Iran. After review of the inclusion and exclusion criteria and explanation
      of the design of the study, written consent form will be completed. The participants are 40
      eligible patients, aged 20-75 years. Intervention group will be received 25 mL/d extra-virgin
      olive oil and control group will be received 25 mL/d refined olive oil for 6 weeks. Fasting
      blood sample will be taken to measure lipid profile, liver enzymes and inflammatory markers
      (Interleukine-6 [IL-6] and Interleukine-10 [IL-10] and C-Reactive Protein [CRP]).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Interleukin-6 (IL-6)
time frame: 6 week
description: change in plasma level of interleukin-6 (IL-6) in pg/mL from baseline at week-6
measure: plasma lipid profile
time frame: 6 week
description: change in plasma level of lipoproteins in mg/dL from baseline at 6 week
measure: plasma liver enzymes (SGOT & SGPT)
time frame: 6 week
description: change in plasma level of liver enzymes (SGOT & SGPT) in mg/dL from baseline at 6 week
measure: Interleukin-10 (IL-10)
time frame: 6 week
description: Change in plasma level of interleukin-10 (IL-10) in pg/mL at baseline and week-6
measure: C reactive protein (CRP)
time frame: 6 week
description: Change in plasma level of C reactive protein (CRP) in mg/dL from baseline and week-6
arm group label: Extra-Virgin Olive Oil
arm group type: Active Comparator
description: Daily consumption of 25 mL Extra-Virgin Olive Oil for 6 weeks
arm group label: Refined Olive Oil
arm group type: Placebo Comparator
description: Daily consumption of 25 mL Refined Olive Oil for 6 weeks
intervention type: Dietary Supplement
intervention name: Extra-Virgin Olive Oil
description: Daily consumption of 25 mL Extra-Virgin Olive Oil in adjunct to medical treatment for 6 weeks
arm group label: Extra-Virgin Olive Oil
intervention type: Dietary Supplement
intervention name: Refined Olive Oil
description: Daily consumption of 25 mL Refined Olive Oil in adjunct to medical treatment for 6 weeks
arm group label: Refined Olive Oil
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Javad Nasrollahzadeh, Ph.D
role: Study Chair
affiliation: Shahid Beheshti University of Medical Sciences
facility: 
country: Iran, Islamic Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Shahid Beheshti University
investigator full name: Javad Nasrollahzadeh
investigator title: Investigator in Clinical Nutrition