Cardiovascular Effects of EVOO in Healthy Reproductive-aged Women

Not Applicable

• Conditions: Hypertension; Vascular Stiffness
• Interventions: Dietary Supplement: Extra Virgin Olive Oil; Dietary Supplement: Control Oil

• Registration Number: NCT03820336
• Lead Sponsor: University of Vermont Medical Center

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 Timeline

• Study First Submitted: 2019-01-23
• Study First Submitted QC: 2019-01-24
• Study First Posted: 2019-01-29
• Study Start: 2019-02-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-17
• Primary Completion: 2020-02
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extra Virgin Olive Oil	Extra Virgin Olive Oil	-
Control Oil	Control Oil	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Triglycerides	1 year	Serum triglycerides in milligrams/deciliter.
Interleukin 6 (IL-6)	1 year	Interleukin 6 in picograms per milliliter. This is a measure of inflammation.
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.
High Density Lipoprotein (HDL) Cholesterol	1 year	Serum high density lipoprotein in milligrams/deciliter.
Hemoglobin A1C	1 year	Serum hemoglobin A1C in percent.
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.
Insulin	1 year	Fasting serum insulin level in micro international units per milliliter (µIU/mL).
B-type natriuretic peptide (BNP)	1 year	B-type natriuretic peptide (BNP) in picograms per milliliter. This is a measure of cardiac function.
Tumor necrosis factor alpha (TNF-α)	1 year	Tumor necrosis factor alpha in picograms per milliliter. This is a measure of inflammation.
Low Density Lipoprotein (LDL) Cholesterol	1 year	Serum low density lipoprotein in milligrams/deciliter.

Trial Locations

Locations (1)

University of Vermont Medical Center; 🇺🇸 Burlington, Vermont, United States