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Cardiovascular Effects of EVOO in Healthy Reproductive-aged Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03820336
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Erin Morris, University of Vermont Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Vascular Stiffness Dietary Supplement: Extra Virgin Olive Oil Dietary Supplement: Control Oil Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cardiovascular Effects of Extra Virgin Olive Oil (EVOO) in Healthy Reproductive-aged Women: A Randomized Controlled Trial
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Olive oil

Arms and Interventions
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Arm Intervention/treatment
Experimental: Extra Virgin Olive Oil Dietary Supplement: Extra Virgin Olive Oil
Subjects will consume 45 ml (40 g) of EVOO daily for 8 weeks.
Placebo Comparator: Control Oil Dietary Supplement: Control Oil
Subjects will consume 45 ml (40 g) of a control sunflower seed oil daily for 8 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Arterial pulse wave velocity [ Time Frame: 8 weeks ]
    Arterial pulse wave velocity in meters/second. This is an index of vessel stiffness.

  2. Blood pressure [ Time Frame: 8 weeks ]
    Blood pressure in millimeters mercury (mm Hg).

  3. Arterial distensibility [ Time Frame: 8 weeks ]
    Arterial distensibility (no units). This is an index of vessel stiffness.

  4. Arterial Beta Stiffness Index [ Time Frame: 8 weeks ]
    Arterial Beta Stiffness Index (no units). This is an index of vessel stiffness.


Secondary Outcome Measures :
  1. Flow-mediated vasodilation [ Time Frame: 8 weeks ]
    Flow-mediated vasodilation in percent. This is a measure of endothelial health.

  2. Cardiac output [ Time Frame: 8 weeks ]
    Cardiac output in liters per minute.

  3. Cardiac output response to volume challenge [ Time Frame: 8 weeks ]
    Cardiac output response to volume challenge in liters per minute. This is a measure of vascular compliance.

  4. C-reactive protein [ Time Frame: 1 year ]
    Serum C-reactive protein in milligrams/liter. This is a marker of inflammation.

  5. High Density Lipoprotein (HDL) Cholesterol [ Time Frame: 1 year ]
    Serum high density lipoprotein in milligrams/deciliter.

  6. Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: 1 year ]
    Serum low density lipoprotein in milligrams/deciliter.

  7. Triglycerides [ Time Frame: 1 year ]
    Serum triglycerides in milligrams/deciliter.

  8. Insulin [ Time Frame: 1 year ]
    Fasting serum insulin level in micro international units per milliliter (µIU/mL).

  9. Hemoglobin A1C [ Time Frame: 1 year ]
    Serum hemoglobin A1C in percent.

  10. B-type natriuretic peptide (BNP) [ Time Frame: 1 year ]
    B-type natriuretic peptide (BNP) in picograms per milliliter. This is a measure of cardiac function.

  11. Interleukin 6 (IL-6) [ Time Frame: 1 year ]
    Interleukin 6 in picograms per milliliter. This is a measure of inflammation.

  12. Tumor necrosis factor alpha (TNF-α) [ Time Frame: 1 year ]
    Tumor necrosis factor alpha in picograms per milliliter. This is a measure of inflammation.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women are eligible to participate if they are between the ages of 18 and 40, in good health, with regular menstrual cycles and no prior pregnancies.

Exclusion Criteria:

  • Routinely take medications or supplements known to affect blood pressure, heart or blood vessel function, or those with anti-inflammatory or antioxidant properties
  • Smoking
  • Pregnancy
  • Other conditions that would impair adherence, such as allergy to olive oil or sunflower oil or difficulty swallowing
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820336


Contacts
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Contact: Erin Morris, MD (802) 847-0408 erin.morris@uvmhealth.org
Contact: Lorinda Roberts (802) 656-5711 lorinda.roberts@uvmhealth.org

Locations
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United States, Vermont
University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05401
Contact: Erin A Morris, MD    802-847-0408    erin.morris@uvmhealth.org   
Sponsors and Collaborators
University of Vermont Medical Center
Investigators
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Principal Investigator: Erin A Morris, MD University of Vermont Medical Center
More Information
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Responsible Party: Erin Morris, Assistant Professor, Maternal-Fetal Medicine, University of Vermont Medical Center
ClinicalTrials.gov Identifier: NCT03820336    
Other Study ID Numbers: 18-0639
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases