Status:
COMPLETED
Effects of EGCG-Enhanced Extra Virgin Olive Oil on Endothelial Function
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Olivi Agri Team Srl- Grosetto, Italy
University of Florence
Conditions:
Atherosclerosis
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00865787
Start Date
February 1 2008
End Date
April 1 2010
Last Update
August 12 2011
Active Locations (1)
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1
St Marys Hospital
Rochester, Minnesota, United States, 55905