Hypertension, Vascular Stiffness
Conditions
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.
Interventions
DIETARY_SUPPLEMENTExtra Virgin Olive Oil
Subjects will consume 45 ml (40 g) of EVOO daily for 8 weeks.
DIETARY_SUPPLEMENTControl Oil
Subjects will consume 45 ml (40 g) of a control sunflower seed oil daily for 8 weeks.
Sponsors
University of Vermont Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
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 * Smoking * Pregnancy * Other conditions that would impair adherence, such as allergy to olive oil or sunflower oil or difficulty swallowing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arterial pulse wave velocity | 8 weeks | Arterial pulse wave velocity in meters/second. This is an index of vessel stiffness. |
| Blood pressure | 8 weeks | Blood pressure in millimeters mercury (mm Hg). |
| Arterial distensibility | 8 weeks | Arterial distensibility (no units). This is an index of vessel stiffness. |
| Arterial Beta Stiffness Index | 8 weeks | Arterial Beta Stiffness Index (no units). This is an index of vessel stiffness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Flow-mediated vasodilation | 8 weeks | Flow-mediated vasodilation in percent. This is a measure of endothelial health. |
| Cardiac output | 8 weeks | Cardiac output in liters per minute. |
| Cardiac output response to volume challenge | 8 weeks | Cardiac output response to volume challenge in liters per minute. This is a measure of vascular compliance. |
| C-reactive protein | 1 year | Serum C-reactive protein in milligrams/liter. This is a marker of inflammation. |
| High Density Lipoprotein (HDL) Cholesterol | 1 year | Serum high density lipoprotein in milligrams/deciliter. |
| Low Density Lipoprotein (LDL) Cholesterol | 1 year | Serum low density lipoprotein in milligrams/deciliter. |
| Triglycerides | 1 year | Serum triglycerides in milligrams/deciliter. |
| Insulin | 1 year | Fasting serum insulin level in micro international units per milliliter (µIU/mL). |
| Hemoglobin A1C | 1 year | Serum hemoglobin A1C in percent. |
| B-type natriuretic peptide (BNP) | 1 year | B-type natriuretic peptide (BNP) in picograms per milliliter. This is a measure of cardiac function. |
| Interleukin 6 (IL-6) | 1 year | Interleukin 6 in picograms per milliliter. This is a measure of inflammation. |
| Tumor necrosis factor alpha (TNF-α) | 1 year | Tumor necrosis factor alpha in picograms per milliliter. This is a measure of inflammation. |
Countries
United States
Contacts
Primary ContactErin Morris, MD
Backup ContactLorinda Roberts
Outcome results
None listed