Recruiting

EVOO

Sponsor:

University of Vermont Medical Center

Code:

NCT03820336

Conditions

Hypertension

Vascular Stiffness

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Extra Virgin Olive Oil

Control Oil

Study Details

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.

Conditions

Hypertension

Vascular Stiffness

Study ID

NCT03820336

Start date

Feb 1, 2019

Status verified date

Apr, 2019

Completion date

Feb, 2020

Anticipated

Primary completion date

Feb, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Extra Virgin Olive Oil

placebo comparator: Control Oil

Interventions

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.

Primary outcome measure

  • Arterial pulse wave velocity [ Time Frame: 8 weeks ]
  • Blood pressure [ Time Frame: 8 weeks ]
  • Arterial distensibility [ Time Frame: 8 weeks ]
  • Arterial Beta Stiffness Index [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Erin Morris, MD

(802) 847-0408erin.morris@uvmhealth.org

Lorinda Roberts

(802) 656-5711lorinda.roberts@uvmhealth.org

Locations

University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Erin A Morris, MD

802-847-0408erin.morris@uvmhealth.org

More Information

Sponsor

University of Vermont Medical Center

Last update posted

Apr 17, 2019

Last verified

Apr, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Vermont Medical Center on 2019-04-17.