Clinical trial NCT03820336: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Vascular Stiffness
Lead sponsor: University of Vermont Medical Center
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Arterial pulse wave velocity
timeFrame: 8 weeks
measure: Blood pressure
timeFrame: 8 weeks
measure: Arterial distensibility
timeFrame: 8 weeks
measure: Arterial Beta Stiffness Index
timeFrame: 8 weeks
Secondary outcomes:
measure: Flow-mediated vasodilation
timeFrame: 8 weeks
measure: Cardiac output
timeFrame: 8 weeks
measure: Cardiac output response to volume challenge
timeFrame: 8 weeks
measure: C-reactive protein
timeFrame: 1 year
measure: High Density Lipoprotein (HDL) Cholesterol
timeFrame: 1 year
measure: Low Density Lipoprotein (LDL) Cholesterol
timeFrame: 1 year
measure: Triglycerides
timeFrame: 1 year
measure: Insulin
timeFrame: 1 year
measure: Hemoglobin A1C
timeFrame: 1 year
measure: B-type natriuretic peptide (BNP)
timeFrame: 1 year
measure: Interleukin 6 (IL-6)
timeFrame: 1 year
measure: Tumor necrosis factor alpha (TNF-α)
timeFrame: 1 year
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
affiliation: University of Vermont Medical Center
name: Erin A Morris, MD
role: PRINCIPAL_INVESTIGATOR
References: