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

This study has been completed.

First Received on February 29, 2008. Last Updated on August 10, 2011 History of Changes

Sponsor:	Mayo Clinic
Collaborators:	Olivi Agri Team Srl- Grosetto, Italy University of Florence
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00865787

Purpose

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
Atherosclerosis

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Effects of EGCG-Enhanced Extra Virgin Olive Oil on Endothelial Function

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: Samples Without DNA

blood

Enrollment:	83
Study Start Date:	February 2008
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
Olive Oil A
Olive Oil B

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Additional Information:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amir Lerman, MN, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00865787 History of Changes
Other Study ID Numbers:	07-002656
Study First Received:	February 29, 2008
Last Updated:	August 10, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012