NCT03820336

Cardiovascular Effects of EVOO in Healthy Reproductive-aged Women

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Vermont Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hypertension
• Vascular Stiffness

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Extra Virgin Olive Oil	Subjects will consume 45 ml (40 g) of EVOO daily for 8 weeks.
DIETARY_SUPPLEMENT	Control Oil	Subjects will consume 45 ml (40 g) of a control sunflower seed oil daily for 8 weeks.

Timeline

• Start date: 2019-02-01
• Primary completion: 2020-02-01
• Completion: 2020-02-01
• First posted: 2019-01-29
• Last updated: 2019-04-17

Locations

1 site across 1 country: United States