Cardiovascular Effects of EVOO in Healthy Reproductive-aged Women
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|ClinicalTrials.gov Identifier: NCT03820336|
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : April 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Vascular Stiffness||Dietary Supplement: Extra Virgin Olive Oil Dietary Supplement: Control Oil||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Cardiovascular Effects of Extra Virgin Olive Oil (EVOO) in Healthy Reproductive-aged Women: A Randomized Controlled Trial|
|Actual Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2020|
|Experimental: Extra Virgin Olive Oil||
Dietary Supplement: Extra Virgin Olive Oil
Subjects will consume 45 ml (40 g) of EVOO daily for 8 weeks.
|Placebo Comparator: Control Oil||
Dietary Supplement: Control Oil
Subjects will consume 45 ml (40 g) of a control sunflower seed oil daily for 8 weeks.
- Arterial pulse wave velocity [ Time Frame: 8 weeks ]Arterial pulse wave velocity in meters/second. This is an index of vessel stiffness.
- Blood pressure [ Time Frame: 8 weeks ]Blood pressure in millimeters mercury (mm Hg).
- Arterial distensibility [ Time Frame: 8 weeks ]Arterial distensibility (no units). This is an index of vessel stiffness.
- Arterial Beta Stiffness Index [ Time Frame: 8 weeks ]Arterial Beta Stiffness Index (no units). This is an index of vessel stiffness.
- Flow-mediated vasodilation [ Time Frame: 8 weeks ]Flow-mediated vasodilation in percent. This is a measure of endothelial health.
- Cardiac output [ Time Frame: 8 weeks ]Cardiac output in liters per minute.
- Cardiac output response to volume challenge [ Time Frame: 8 weeks ]Cardiac output response to volume challenge in liters per minute. This is a measure of vascular compliance.
- C-reactive protein [ Time Frame: 1 year ]Serum C-reactive protein in milligrams/liter. This is a marker of inflammation.
- High Density Lipoprotein (HDL) Cholesterol [ Time Frame: 1 year ]Serum high density lipoprotein in milligrams/deciliter.
- Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: 1 year ]Serum low density lipoprotein in milligrams/deciliter.
- Triglycerides [ Time Frame: 1 year ]Serum triglycerides in milligrams/deciliter.
- Insulin [ Time Frame: 1 year ]Fasting serum insulin level in micro international units per milliliter (µIU/mL).
- Hemoglobin A1C [ Time Frame: 1 year ]Serum hemoglobin A1C in percent.
- B-type natriuretic peptide (BNP) [ Time Frame: 1 year ]B-type natriuretic peptide (BNP) in picograms per milliliter. This is a measure of cardiac function.
- Interleukin 6 (IL-6) [ Time Frame: 1 year ]Interleukin 6 in picograms per milliliter. This is a measure of inflammation.
- Tumor necrosis factor alpha (TNF-α) [ Time Frame: 1 year ]Tumor necrosis factor alpha in picograms per milliliter. This is a measure of inflammation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820336
|Contact: Erin Morris, MD||(802) email@example.com|
|Contact: Lorinda Roberts||(802) firstname.lastname@example.org|
|United States, Vermont|
|University of Vermont Medical Center||Recruiting|
|Burlington, Vermont, United States, 05401|
|Contact: Erin A Morris, MD 802-847-0408 email@example.com|
|Principal Investigator:||Erin A Morris, MD||University of Vermont Medical Center|