<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/NCT03005535</url>
  </required_header>
  <id_info>
    <org_study_id>ECLIPSE_2016</org_study_id>
    <nct_id>NCT03005535</nct_id>
  </id_info>
  <brief_title>Effects of Corn Oil Plus Vitamin E and B6 on LIpids, PcSk9 and Endothelial Function</brief_title>
  <acronym>ECLIPSE</acronym>
  <official_title>Randomised Clinical Trial to Assess the Medium-term Effect of 30 g/Day of a Vitaminised Corn Oil or Olive Oil, on Lipid Parameters, Vascular Risk Markers Blood Pressure and Endothelial Function, in Moderately Hypercholesterolemic Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bologna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Bologna</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This will be a randomized clinical trial carried out on subjects with suboptimal control of&#xD;
      cholesterolemia who will consume 30 g per day of a vitaminized corn oil (plus B6 and E&#xD;
      vitamins), in order to evaluate the effects on lipid profile, endothelial function and PCSK9&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In order to assess the mid term effects of vitaminized corn oil on endothelial function and&#xD;
      on early markers of functional damage of the arterial wall, moderately hypercholesterolemic&#xD;
      subjects will be supplemented for 8 weeks with 30 g/day of both a vitaminized corn oil (plus&#xD;
      B6 and E vitamins) or olive oil. The two intervention periods will be spaced by a 4 week&#xD;
      washout period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">November 2017</completion_date>
  <primary_completion_date type="Anticipated">February 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Endothelial function (measured by Endocheck) change from the baseline to the end of the intervention period</measure>
    <time_frame>At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>12 hour fasting lipid profile change from the baseline to the end of the intervention period</measure>
    <time_frame>At the first visit (run-in) at the beginning, after 4 and 8 weeks of both intervention periods (up to 24 weeks)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PCSK9 levels change from the baseline to the end of the intervention period</measure>
    <time_frame>At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inflammatory markers (high sensitivity C reactive protein hs-PCR, malondialdehyde MDA, homocysteine) change from the baseline to the end of the intervention period</measure>
    <time_frame>At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure change from the baseline to the end of the intervention period</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatty acid profile of whole blood total lipids change from the baseline to the end of the intervention period</measure>
    <time_frame>At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Atherosclerosis</condition>
  <arm_group>
    <arm_group_label>Vitaminized corn oil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vitaminized corn oil (plus B6 and E vitamins), 30 g per day, per 8 weeks, with meals (15 g per meal)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Olive oil</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Olive oil (not extra-virgin), 30 g per day, per 8 weeks, with meals (15 g per meal)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vitaminized corn oil</intervention_name>
    <description>Oil consumption at the two main meals, lunch and dinner (15gx2 per day)</description>
    <arm_group_label>Vitaminized corn oil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Olive oil</intervention_name>
    <description>Oil consumption at the two main meals, lunch and dinner (15gx2 per day)</description>
    <arm_group_label>Olive oil</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Total cholesterol between 200 and 280 mg/dL and/or LDL cholesterol between 130 and 190&#xD;
             mg/dL&#xD;
&#xD;
          -  Triglycerides lower than 200 mg/dL&#xD;
&#xD;
          -  Cardiovascular risk at 10 years lower than 10%&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secundary prevention for cardiovascular diseases&#xD;
&#xD;
          -  BMI higher than 30&#xD;
&#xD;
          -  Assumption of lipid lowering drug or supplement&#xD;
&#xD;
          -  Alcohol abuse&#xD;
&#xD;
          -  Alterations in thyroid, liver or kidney functions, muscle diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>S. Orsola-Malpighi University Hospital</name>
      <address>
        <city>Bologna</city>
        <state>BO</state>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>December 25, 2016</last_update_submitted>
  <last_update_submitted_qc>December 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Bologna</investigator_affiliation>
    <investigator_full_name>Claudio Borghi</investigator_full_name>
    <investigator_title>Chief Internal Medicine Unit</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atherosclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03005535
org study id: ECLIPSE_2016
nct id: NCT03005535
lead sponsor: 
has dmc: Yes
This will be a randomized clinical trial carried out on subjects with suboptimal control of
      cholesterolemia who will consume 30 g per day of a vitaminized corn oil (plus B6 and E
      vitamins), in order to evaluate the effects on lipid profile, endothelial function and PCSK9
In order to assess the mid term effects of vitaminized corn oil on endothelial function and
      on early markers of functional damage of the arterial wall, moderately hypercholesterolemic
      subjects will be supplemented for 8 weeks with 30 g/day of both a vitaminized corn oil (plus
      B6 and E vitamins) or olive oil. The two intervention periods will be spaced by a 4 week
      washout period.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Endothelial function (measured by Endocheck) change from the baseline to the end of the intervention period
time frame: At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)
measure: 12 hour fasting lipid profile change from the baseline to the end of the intervention period
time frame: At the first visit (run-in) at the beginning, after 4 and 8 weeks of both intervention periods (up to 24 weeks)
measure: PCSK9 levels change from the baseline to the end of the intervention period
time frame: At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)
measure: Inflammatory markers (high sensitivity C reactive protein hs-PCR, malondialdehyde MDA, homocysteine) change from the baseline to the end of the intervention period
time frame: At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)
measure: Blood pressure change from the baseline to the end of the intervention period
time frame: 6 months
measure: Fatty acid profile of whole blood total lipids change from the baseline to the end of the intervention period
time frame: At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)
arm group label: Vitaminized corn oil
arm group type: Active Comparator
description: Vitaminized corn oil (plus B6 and E vitamins), 30 g per day, per 8 weeks, with meals (15 g per meal)
arm group label: Olive oil
arm group type: Placebo Comparator
description: Olive oil (not extra-virgin), 30 g per day, per 8 weeks, with meals (15 g per meal)
intervention type: Other
intervention name: Vitaminized corn oil
description: Oil consumption at the two main meals, lunch and dinner (15gx2 per day)
arm group label: Vitaminized corn oil
intervention type: Other
intervention name: Olive oil
description: Oil consumption at the two main meals, lunch and dinner (15gx2 per day)
arm group label: Olive oil
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Bologna
investigator full name: Claudio Borghi
investigator title: Chief Internal Medicine Unit
mesh term: Atherosclerosis
sharing ipd: Yes