Cardiovascular Effects of Extra Virgin Olive Oil (EVOO) in Healthy Reproductive-aged Women: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Arterial Beta Stiffness Index
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
- •Pregnancy
- •Other conditions that would impair adherence, such as allergy to olive oil or sunflower oil or difficulty swallowing
Arms & Interventions
Control Oil
Intervention: Control Oil (Dietary Supplement)
Extra Virgin Olive Oil
Intervention: Extra Virgin Olive Oil (Dietary Supplement)
Outcomes
Primary Outcomes
Arterial Beta Stiffness Index
Time Frame: 8 weeks
Arterial Beta Stiffness Index (no units). This is an index of vessel stiffness.
Blood pressure
Time Frame: 8 weeks
Blood pressure in millimeters mercury (mm Hg).
Arterial pulse wave velocity
Time Frame: 8 weeks
Arterial pulse wave velocity in meters/second. This is an index of vessel stiffness.
Arterial distensibility
Time Frame: 8 weeks
Arterial distensibility (no units). This is an index of vessel stiffness.
Secondary Outcomes
- Triglycerides(1 year)
- Interleukin 6 (IL-6)(1 year)
- Flow-mediated vasodilation(8 weeks)
- Hemoglobin A1C(1 year)
- Cardiac output(8 weeks)
- High Density Lipoprotein (HDL) Cholesterol(1 year)
- Cardiac output response to volume challenge(8 weeks)
- C-reactive protein(1 year)
- Insulin(1 year)
- B-type natriuretic peptide (BNP)(1 year)
- Tumor necrosis factor alpha (TNF-α)(1 year)
- Low Density Lipoprotein (LDL) Cholesterol(1 year)
Investigators
Erin Morris
Assistant Professor, Maternal-Fetal Medicine
University of Vermont Medical Center