Atherosclerosis
Conditions
Brief summary
This study is being done to determine if the use of EGCG-Enhanced Extra Virgin Olive Oil in a daily diet will improve endothelial function.
Detailed description
Patients will be randomized to receive either placebo ROO (refined olive oil) or study solution EGCG-EVOO (EGCG enhanced extra-virgin olive oil) over the four month study period.
Interventions
None listed
Sponsors
Olivi Agri Team Srl- Grosetto, Italy
University of Florence
Mayo Clinic
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients will be included in the study if they have an abnormal endothelial function study. This is defined at our institution as an RH-PAT index of less than 2. Patients will undergo two RH-PAT analyses and included abnormal values are obtained on either one or both tests. Only patients who provide written informed consent will be included.
Exclusion criteria
* Patients with normal baseline endothelial function studies defined as RH-PAT index \>2 will be excluded. Patients with uncontrolled hypertension \>180/100 while on medication on initial evaluation will also be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Supplementation with enhanced olive oil will improve endothelial function as assessed by the reactive hyperemia peripheral arterial tonometry (RH-PAT) in patients with coronary artery disease (CAD) risk factors and endothelial dysfunction | Baseline and post 4 month |
Secondary
| Measure | Time frame |
|---|---|
| Supplementation of EGCG enhanced olive oil will reduce peripheral markers of endothelial dysfunction and inflammation, oxidative stress and inflammation | Baseline and post 4 month |
Countries
United States
Outcome results
None listed