<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/NCT03820336</url>
  </required_header>
  <id_info>
    <org_study_id>18-0639</org_study_id>
    <nct_id>NCT03820336</nct_id>
  </id_info>
  <brief_title>Cardiovascular Effects of EVOO in Healthy Reproductive-aged Women</brief_title>
  <official_title>Cardiovascular Effects of Extra Virgin Olive Oil (EVOO) in Healthy Reproductive-aged Women: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Vermont Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Vermont Medical Center</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>
      This study aims to compare changes in cardiovascular function and markers of inflammation and&#xD;
      metabolic dysfunction in women randomized to treatment with extra virgin olive oil (EVOO)&#xD;
      versus those randomized to treatment with a control oil low in oleic acid and phenols for 8&#xD;
      weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be randomized to receive 45 ml (40 g) of extra virgin olive oil (EVOO)&#xD;
      daily for 8 weeks or an identical dose of a control sunflower seed oil low in oleic acid and&#xD;
      phenol content. EVOO high in oleic acid and phenolic content will be identified and shipped&#xD;
      from Italy and stored protected from heat and light in the Bionutrition Core at the Clinical&#xD;
      Research Center at the University of Vermont Medical Center. Women will undergo a detailed&#xD;
      cardiovascular assessment at baseline and following treatment, including assessment of blood&#xD;
      pressure, pulse-wave velocity, calculation of arterial distensibility and beta stiffness,&#xD;
      flow-mediated vasodilation, cardiac output, response to volume challenge and dual-energy&#xD;
      X-ray absorptiometry (DEXA). Lipid profiles and markers of inflammation, oxidative stress and&#xD;
      metabolic dysfunction will also be assessed at both study visits.&#xD;
&#xD;
      Investigators hypothesize that treatment with high oleic acid and phenolic EVOO will be&#xD;
      associated with decreased blood pressure, improved vascular compliance and blood vessel&#xD;
      function, and with improvement in lipid profile, inflammation and markers of metabolic&#xD;
      dysfunction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">February 2020</completion_date>
  <primary_completion_date type="Anticipated">February 2020</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Arterial pulse wave velocity</measure>
    <time_frame>8 weeks</time_frame>
    <description>Arterial pulse wave velocity in meters/second. This is an index of vessel stiffness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>8 weeks</time_frame>
    <description>Blood pressure in millimeters mercury (mm Hg).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arterial distensibility</measure>
    <time_frame>8 weeks</time_frame>
    <description>Arterial distensibility (no units). This is an index of vessel stiffness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arterial Beta Stiffness Index</measure>
    <time_frame>8 weeks</time_frame>
    <description>Arterial Beta Stiffness Index (no units). This is an index of vessel stiffness.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Flow-mediated vasodilation</measure>
    <time_frame>8 weeks</time_frame>
    <description>Flow-mediated vasodilation in percent. This is a measure of endothelial health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac output</measure>
    <time_frame>8 weeks</time_frame>
    <description>Cardiac output in liters per minute.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac output response to volume challenge</measure>
    <time_frame>8 weeks</time_frame>
    <description>Cardiac output response to volume challenge in liters per minute. This is a measure of vascular compliance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein</measure>
    <time_frame>1 year</time_frame>
    <description>Serum C-reactive protein in milligrams/liter. This is a marker of inflammation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High Density Lipoprotein (HDL) Cholesterol</measure>
    <time_frame>1 year</time_frame>
    <description>Serum high density lipoprotein in milligrams/deciliter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Low Density Lipoprotein (LDL) Cholesterol</measure>
    <time_frame>1 year</time_frame>
    <description>Serum low density lipoprotein in milligrams/deciliter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>1 year</time_frame>
    <description>Serum triglycerides in milligrams/deciliter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin</measure>
    <time_frame>1 year</time_frame>
    <description>Fasting serum insulin level in micro international units per milliliter (µIU/mL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin A1C</measure>
    <time_frame>1 year</time_frame>
    <description>Serum hemoglobin A1C in percent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>B-type natriuretic peptide (BNP)</measure>
    <time_frame>1 year</time_frame>
    <description>B-type natriuretic peptide (BNP) in picograms per milliliter. This is a measure of cardiac function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interleukin 6 (IL-6)</measure>
    <time_frame>1 year</time_frame>
    <description>Interleukin 6 in picograms per milliliter. This is a measure of inflammation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor necrosis factor alpha (TNF-α)</measure>
    <time_frame>1 year</time_frame>
    <description>Tumor necrosis factor alpha in picograms per milliliter. This is a measure of inflammation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Hypertension</condition>
  <condition>Vascular Stiffness</condition>
  <arm_group>
    <arm_group_label>Extra Virgin Olive Oil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Oil</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Extra Virgin Olive Oil</intervention_name>
    <description>Subjects will consume 45 ml (40 g) of EVOO daily for 8 weeks.</description>
    <arm_group_label>Extra Virgin Olive Oil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Control Oil</intervention_name>
    <description>Subjects will consume 45 ml (40 g) of a control sunflower seed oil daily for 8 weeks.</description>
    <arm_group_label>Control Oil</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women are eligible to participate if they are between the ages of 18 and 40, in good&#xD;
             health, with regular menstrual cycles and no prior pregnancies.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Routinely take medications or supplements known to affect blood pressure, heart or&#xD;
             blood vessel function, or those with anti-inflammatory or antioxidant properties&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Other conditions that would impair adherence, such as allergy to olive oil or&#xD;
             sunflower oil or difficulty swallowing&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erin A Morris, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Vermont Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Erin Morris, MD</last_name>
    <phone>(802) 847-0408</phone>
    <email>erin.morris@uvmhealth.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lorinda Roberts</last_name>
    <phone>(802) 656-5711</phone>
    <email>lorinda.roberts@uvmhealth.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Vermont Medical Center</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Erin A Morris, MD</last_name>
      <phone>802-847-0408</phone>
      <email>erin.morris@uvmhealth.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>April 15, 2019</last_update_submitted>
  <last_update_submitted_qc>April 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Vermont Medical Center</investigator_affiliation>
    <investigator_full_name>Erin Morris</investigator_full_name>
    <investigator_title>Assistant Professor, Maternal-Fetal Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</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/NCT03820336
org study id: 18-0639
nct id: NCT03820336
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to compare changes in cardiovascular function and markers of inflammation and
      metabolic dysfunction in women randomized to treatment with extra virgin olive oil (EVOO)
      versus those randomized to treatment with a control oil low in oleic acid and phenols for 8
      weeks.
Participants will be randomized to receive 45 ml (40 g) of extra virgin olive oil (EVOO)
      daily for 8 weeks or an identical dose of a control sunflower seed oil low in oleic acid and
      phenol content. EVOO high in oleic acid and phenolic content will be identified and shipped
      from Italy and stored protected from heat and light in the Bionutrition Core at the Clinical
      Research Center at the University of Vermont Medical Center. Women will undergo a detailed
      cardiovascular assessment at baseline and following treatment, including assessment of blood
      pressure, pulse-wave velocity, calculation of arterial distensibility and beta stiffness,
      flow-mediated vasodilation, cardiac output, response to volume challenge and dual-energy
      X-ray absorptiometry (DEXA). Lipid profiles and markers of inflammation, oxidative stress and
      metabolic dysfunction will also be assessed at both study visits.

      Investigators hypothesize that treatment with high oleic acid and phenolic EVOO will be
      associated with decreased blood pressure, improved vascular compliance and blood vessel
      function, and with improvement in lipid profile, inflammation and markers of metabolic
      dysfunction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Arterial pulse wave velocity
time frame: 8 weeks
description: Arterial pulse wave velocity in meters/second. This is an index of vessel stiffness.
measure: Blood pressure
time frame: 8 weeks
description: Blood pressure in millimeters mercury (mm Hg).
measure: Arterial distensibility
time frame: 8 weeks
description: Arterial distensibility (no units). This is an index of vessel stiffness.
measure: Arterial Beta Stiffness Index
time frame: 8 weeks
description: Arterial Beta Stiffness Index (no units). This is an index of vessel stiffness.
measure: Flow-mediated vasodilation
time frame: 8 weeks
description: Flow-mediated vasodilation in percent. This is a measure of endothelial health.
measure: Cardiac output
time frame: 8 weeks
description: Cardiac output in liters per minute.
measure: Cardiac output response to volume challenge
time frame: 8 weeks
description: Cardiac output response to volume challenge in liters per minute. This is a measure of vascular compliance.
measure: C-reactive protein
time frame: 1 year
description: Serum C-reactive protein in milligrams/liter. This is a marker of inflammation.
measure: High Density Lipoprotein (HDL) Cholesterol
time frame: 1 year
description: Serum high density lipoprotein in milligrams/deciliter.
measure: Low Density Lipoprotein (LDL) Cholesterol
time frame: 1 year
description: Serum low density lipoprotein in milligrams/deciliter.
measure: Triglycerides
time frame: 1 year
description: Serum triglycerides in milligrams/deciliter.
measure: Insulin
time frame: 1 year
description: Fasting serum insulin level in micro international units per milliliter (µIU/mL).
measure: Hemoglobin A1C
time frame: 1 year
description: Serum hemoglobin A1C in percent.
measure: B-type natriuretic peptide (BNP)
time frame: 1 year
description: B-type natriuretic peptide (BNP) in picograms per milliliter. This is a measure of cardiac function.
measure: Interleukin 6 (IL-6)
time frame: 1 year
description: Interleukin 6 in picograms per milliliter. This is a measure of inflammation.
measure: Tumor necrosis factor alpha (TNF-α)
time frame: 1 year
description: Tumor necrosis factor alpha in picograms per milliliter. This is a measure of inflammation.
arm group label: Extra Virgin Olive Oil
arm group type: Experimental
arm group label: Control Oil
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: Extra Virgin Olive Oil
description: Subjects will consume 45 ml (40 g) of EVOO daily for 8 weeks.
arm group label: Extra Virgin Olive Oil
intervention type: Dietary Supplement
intervention name: Control Oil
description: Subjects will consume 45 ml (40 g) of a control sunflower seed oil daily for 8 weeks.
arm group label: Control Oil
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Erin A Morris, MD
role: Principal Investigator
affiliation: University of Vermont Medical Center
last name: Erin Morris, MD
phone: (802) 847-0408
email: erin.morris@uvmhealth.org
last name: Lorinda Roberts
phone: (802) 656-5711
email: lorinda.roberts@uvmhealth.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Vermont Medical Center
investigator full name: Erin Morris
investigator title: Assistant Professor, Maternal-Fetal Medicine
mesh term: Hypertension
sharing ipd: No