Cardiovascular Effects of EVOO in Healthy Reproductive-aged Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2020-02-29

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.

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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.

Conditions

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Hypertension Vascular Stiffness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Extra Virgin Olive Oil

Group Type EXPERIMENTAL

Extra Virgin Olive Oil

Intervention Type DIETARY_SUPPLEMENT

Subjects will consume 45 ml (40 g) of EVOO daily for 8 weeks.

Control Oil

Group Type PLACEBO_COMPARATOR

Control Oil

Intervention Type DIETARY_SUPPLEMENT

Subjects will consume 45 ml (40 g) of a control sunflower seed oil daily for 8 weeks.

Interventions

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Extra Virgin Olive Oil

Subjects will consume 45 ml (40 g) of EVOO daily for 8 weeks.

Intervention Type DIETARY_SUPPLEMENT

Control Oil

Subjects will consume 45 ml (40 g) of a control sunflower seed oil daily for 8 weeks.

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes