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

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ClinicalTrials.gov Identifier: NCT00865787
Recruitment Status : Completed
First Posted : March 19, 2009
Last Update Posted : August 12, 2011
Sponsor:
Collaborators:
Olivi Agri Team Srl- Grosetto, Italy
University of Florence
Information provided by:
Mayo Clinic

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.

Condition or disease
Atherosclerosis

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.

Study Type : Observational
Actual Enrollment : 83 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects of EGCG-Enhanced Extra Virgin Olive Oil on Endothelial Function
Study Start Date : February 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Olive oil
U.S. FDA Resources

Group/Cohort
Olive Oil A
Olive Oil B



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples Without DNA
blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Mayo Clinic Patients
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00865787


Locations
United States, Minnesota
St Marys Hospital
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Olivi Agri Team Srl- Grosetto, Italy
University of Florence
Investigators
Principal Investigator: Amir Lerman, MD Mayo Clinic

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amir Lerman, MN, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00865787     History of Changes
Other Study ID Numbers: 07-002656
First Posted: March 19, 2009    Key Record Dates
Last Update Posted: August 12, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases