Cardiovascular Effects of EVOO in Healthy Reproductive-aged Women

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypertension, Vascular Stiffness

Intervention / Treatment
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* Dietary Supplement: Extra Virgin Olive Oil
* Dietary Supplement: Control Oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extra Virgin Olive Oil<br> | Dietary Supplement: Extra Virgin Olive Oil<br>* Subjects will consume 45 ml (40 g) of EVOO daily for 8 weeks.<br>|
| Placebo Comparator: Control Oil<br> | Dietary Supplement: Control Oil<br>* Subjects will consume 45 ml (40 g) of a control sunflower seed oil daily for 8 weeks.<br>|

What is the study measuring?
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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 |