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.
- 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.
- 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.
The purpose of this study is to find out if the use of olive oil in your daily diet will improve endothelial function. Endothelial dysfunction is when the tissue lining in the arteries is not functioning correctly. To determine if you have endothelial dysfunction you will have a special test called EndoPAT. This is a non invasive test that will take about 20 minutes. If you qualify after the EndoPAT test you will have be asked to complete a questionnaire and to do a blood draw. The minimum appointment time is 30 minutes and the maximum appointment time is 1.5 hours. You will also need to fast for 4 hours prior to testing.
If you qualify you will receive either a 4 month supply of 'enhanced' olive oil or placebo. The daily intake will be 2 Tablespoons. After the 4 months you will be asked to do another EndoPAT test, a blood draw and a questionnaire.
Last updated: 08/10/2011
NCT ID: NCT00865787