Cardiovascular Effects of EVOO in Healthy Reproductive-aged Women

Cardiovascular Effects of Extra Virgin Olive Oil (EVOO) in Healthy Reproductive-aged Women: A Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension; Vascular Stiffness
• Intervention / Treatment: Dietary supplement: Extra Virgin Olive Oil; Dietary supplement: Control Oil

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Recruiting
      • University of Vermont Medical Center
      • Contact: Erin A Morris, MD; Phone Number: 802-847-0408; Email: erin.morris@uvmhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial pulse wave velocity	Arterial pulse wave velocity in meters/second. This is an index of vessel stiffness.	8 weeks
Blood pressure	Blood pressure in millimeters mercury (mm Hg).	8 weeks
Arterial distensibility	Arterial distensibility (no units). This is an index of vessel stiffness.	8 weeks
Arterial Beta Stiffness Index	Arterial Beta Stiffness Index (no units). This is an index of vessel stiffness.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flow-mediated vasodilation	Flow-mediated vasodilation in percent. This is a measure of endothelial health.	8 weeks
Cardiac output	Cardiac output in liters per minute.	8 weeks
Cardiac output response to volume challenge	Cardiac output response to volume challenge in liters per minute. This is a measure of vascular compliance.	8 weeks
C-reactive protein	Serum C-reactive protein in milligrams/liter. This is a marker of inflammation.	1 year
High Density Lipoprotein (HDL) Cholesterol	Serum high density lipoprotein in milligrams/deciliter.	1 year
Low Density Lipoprotein (LDL) Cholesterol	Serum low density lipoprotein in milligrams/deciliter.	1 year
Triglycerides	Serum triglycerides in milligrams/deciliter.	1 year
Insulin	Fasting serum insulin level in micro international units per milliliter (µIU/mL).	1 year
Hemoglobin A1C	Serum hemoglobin A1C in percent.	1 year
B-type natriuretic peptide (BNP)	B-type natriuretic peptide (BNP) in picograms per milliliter. This is a measure of cardiac function.	1 year
Interleukin 6 (IL-6)	Interleukin 6 in picograms per milliliter. This is a measure of inflammation.	1 year
Tumor necrosis factor alpha (TNF-α)	Tumor necrosis factor alpha in picograms per milliliter. This is a measure of inflammation.	1 year

Collaborators and Investigators

• Sponsor: University of Vermont Medical Center
• Investigators: Principal Investigator: Erin A Morris, MD, University of Vermont Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2019
• Primary Completion (ANTICIPATED): February 1, 2020
• Study Completion (ANTICIPATED): February 1, 2020

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (ACTUAL): January 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 18-0639

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No