Effects of EGCG-Enhanced Extra Virgin Olive Oil on Endothelial Function

This study has been completed.
Sponsor:
Collaborators:
Olivi Agri Team Srl- Grosetto, Italy
University of Florence
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00865787
First received: February 29, 2008
Last updated: August 10, 2011
Last verified: August 2011

February 29, 2008
August 10, 2011
February 2008
April 2010   (final data collection date for primary outcome measure)
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 [ Time Frame: Baseline and post 4 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00865787 on ClinicalTrials.gov Archive Site
Supplementation of EGCG enhanced olive oil will reduce peripheral markers of endothelial dysfunction and inflammation, oxidative stress and inflammation [ Time Frame: Baseline and post 4 month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of EGCG-Enhanced Extra Virgin Olive Oil on Endothelial Function
Effects of EGCG-Enhanced Extra Virgin Olive Oil on Endothelial Function

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

blood

Non-Probability Sample

Mayo Clinic Patients

Atherosclerosis
Not Provided
  • Olive Oil A
  • Olive Oil B
Widmer RJ, Freund MA, Flammer AJ, Sexton J, Lennon R, Romani A, Mulinacci N, Vinceri FF, Lerman LO, Lerman A. Beneficial effects of polyphenol-rich olive oil in patients with early atherosclerosis. Eur J Nutr. 2013 Apr;52(3):1223-31. doi: 10.1007/s00394-012-0433-2. Epub 2012 Aug 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
April 2010
April 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00865787
07-002656
No
Amir Lerman, MN, Mayo Clinic
Mayo Clinic
  • Olivi Agri Team Srl- Grosetto, Italy
  • University of Florence
Principal Investigator: Amir Lerman, MD Mayo Clinic
Mayo Clinic
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP