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Cardiovascular Effects of EVOO in Healthy Reproductive-aged Women

Primary Purpose

Hypertension, Vascular Stiffness

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Extra Virgin Olive Oil
Control Oil
Sponsored by
University of Vermont Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Vermont Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Extra Virgin Olive Oil

Control Oil

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Flow-mediated vasodilation
Flow-mediated vasodilation in percent. This is a measure of endothelial health.
Cardiac output
Cardiac output in liters per minute.
Cardiac output response to volume challenge
Cardiac output response to volume challenge in liters per minute. This is a measure of vascular compliance.
C-reactive protein
Serum C-reactive protein in milligrams/liter. This is a marker of inflammation.
High Density Lipoprotein (HDL) Cholesterol
Serum high density lipoprotein in milligrams/deciliter.
Low Density Lipoprotein (LDL) Cholesterol
Serum low density lipoprotein in milligrams/deciliter.
Triglycerides
Serum triglycerides in milligrams/deciliter.
Insulin
Fasting serum insulin level in micro international units per milliliter (µIU/mL).
Hemoglobin A1C
Serum hemoglobin A1C in percent.
B-type natriuretic peptide (BNP)
B-type natriuretic peptide (BNP) in picograms per milliliter. This is a measure of cardiac function.
Interleukin 6 (IL-6)
Interleukin 6 in picograms per milliliter. This is a measure of inflammation.
Tumor necrosis factor alpha (TNF-α)
Tumor necrosis factor alpha in picograms per milliliter. This is a measure of inflammation.

Full Information

First Posted
January 23, 2019
Last Updated
April 15, 2019
Sponsor
University of Vermont Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03820336
Brief Title
Cardiovascular Effects of EVOO in Healthy Reproductive-aged Women
Official Title
Cardiovascular Effects of Extra Virgin Olive Oil (EVOO) in Healthy Reproductive-aged Women: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
February 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Vascular Stiffness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Extra Virgin Olive Oil
Arm Type
Experimental
Arm Title
Control Oil
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Extra Virgin Olive Oil
Intervention Description
Subjects will consume 45 ml (40 g) of EVOO daily for 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Control Oil
Intervention Description
Subjects will consume 45 ml (40 g) of a control sunflower seed oil daily for 8 weeks.
Primary Outcome Measure Information:
Title
Arterial pulse wave velocity
Description
Arterial pulse wave velocity in meters/second. This is an index of vessel stiffness.
Time Frame
8 weeks
Title
Blood pressure
Description
Blood pressure in millimeters mercury (mm Hg).
Time Frame
8 weeks
Title
Arterial distensibility
Description
Arterial distensibility (no units). This is an index of vessel stiffness.
Time Frame
8 weeks
Title
Arterial Beta Stiffness Index
Description
Arterial Beta Stiffness Index (no units). This is an index of vessel stiffness.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Flow-mediated vasodilation
Description
Flow-mediated vasodilation in percent. This is a measure of endothelial health.
Time Frame
8 weeks
Title
Cardiac output
Description
Cardiac output in liters per minute.
Time Frame
8 weeks
Title
Cardiac output response to volume challenge
Description
Cardiac output response to volume challenge in liters per minute. This is a measure of vascular compliance.
Time Frame
8 weeks
Title
C-reactive protein
Description
Serum C-reactive protein in milligrams/liter. This is a marker of inflammation.
Time Frame
1 year
Title
High Density Lipoprotein (HDL) Cholesterol
Description
Serum high density lipoprotein in milligrams/deciliter.
Time Frame
1 year
Title
Low Density Lipoprotein (LDL) Cholesterol
Description
Serum low density lipoprotein in milligrams/deciliter.
Time Frame
1 year
Title
Triglycerides
Description
Serum triglycerides in milligrams/deciliter.
Time Frame
1 year
Title
Insulin
Description
Fasting serum insulin level in micro international units per milliliter (µIU/mL).
Time Frame
1 year
Title
Hemoglobin A1C
Description
Serum hemoglobin A1C in percent.
Time Frame
1 year
Title
B-type natriuretic peptide (BNP)
Description
B-type natriuretic peptide (BNP) in picograms per milliliter. This is a measure of cardiac function.
Time Frame
1 year
Title
Interleukin 6 (IL-6)
Description
Interleukin 6 in picograms per milliliter. This is a measure of inflammation.
Time Frame
1 year
Title
Tumor necrosis factor alpha (TNF-α)
Description
Tumor necrosis factor alpha in picograms per milliliter. This is a measure of inflammation.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Morris, MD
Phone
(802) 847-0408
Email
erin.morris@uvmhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Lorinda Roberts
Phone
(802) 656-5711
Email
lorinda.roberts@uvmhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin A Morris, MD
Organizational Affiliation
University of Vermont Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin A Morris, MD
Phone
802-847-0408
Email
erin.morris@uvmhealth.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Cardiovascular Effects of EVOO in Healthy Reproductive-aged Women

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