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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014