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
  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:


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:
No publications provided by Mayo Clinic

Additional 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
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 April 17, 2014