Cardiovascular Effects of EVOO in Healthy Reproductive-aged Women

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03820336
• Other study ID #: 18-0639
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: February 2020

Study information

• Verified date: April 2019
• Source: University of Vermont Medical Center
• Contact: Erin Morris, MD
• Phone: (802) 847-0408
• Email: erin.morris[@]uvmhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Vascular Stiffness

Intervention

Dietary Supplement:
• Extra Virgin Olive Oil
Subjects will consume 45 ml (40 g) of EVOO daily for 8 weeks.
• Control Oil
Subjects will consume 45 ml (40 g) of a control sunflower seed oil daily for 8 weeks.

Locations

Country	Name	City	State
United States	University of Vermont Medical Center	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial pulse wave velocity	Arterial pulse wave velocity in meters/second. This is an index of vessel stiffness.	8 weeks
Primary	Blood pressure	Blood pressure in millimeters mercury (mm Hg).	8 weeks
Primary	Arterial distensibility	Arterial distensibility (no units). This is an index of vessel stiffness.	8 weeks
Primary	Arterial Beta Stiffness Index	Arterial Beta Stiffness Index (no units). This is an index of vessel stiffness.	8 weeks
Secondary	Flow-mediated vasodilation	Flow-mediated vasodilation in percent. This is a measure of endothelial health.	8 weeks
Secondary	Cardiac output	Cardiac output in liters per minute.	8 weeks
Secondary	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
Secondary	C-reactive protein	Serum C-reactive protein in milligrams/liter. This is a marker of inflammation.	1 year
Secondary	High Density Lipoprotein (HDL) Cholesterol	Serum high density lipoprotein in milligrams/deciliter.	1 year
Secondary	Low Density Lipoprotein (LDL) Cholesterol	Serum low density lipoprotein in milligrams/deciliter.	1 year
Secondary	Triglycerides	Serum triglycerides in milligrams/deciliter.	1 year
Secondary	Insulin	Fasting serum insulin level in micro international units per milliliter (µIU/mL).	1 year
Secondary	Hemoglobin A1C	Serum hemoglobin A1C in percent.	1 year
Secondary	B-type natriuretic peptide (BNP)	B-type natriuretic peptide (BNP) in picograms per milliliter. This is a measure of cardiac function.	1 year
Secondary	Interleukin 6 (IL-6)	Interleukin 6 in picograms per milliliter. This is a measure of inflammation.	1 year
Secondary	Tumor necrosis factor alpha (TNF-a)	Tumor necrosis factor alpha in picograms per milliliter. This is a measure of inflammation.	1 year