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NCT00865787 Clinical Trial

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

Atherosclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00865787
Other study ID # 07-002656
Secondary ID
Status Completed
Phase N/A
First received February 29, 2008
Last updated August 10, 2011
Start date February 2008
Est. completion date April 2010

Study information
Verified date August 2011
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 83
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States St Marys Hospital Rochester Minnesota

Sponsors (3)
Lead Sponsor Collaborator
Mayo Clinic Olivi Agri Team Srl- Grosetto, Italy, University of Florence

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Baseline and post 4 month No
Secondary Supplementation of EGCG enhanced olive oil will reduce peripheral markers of endothelial dysfunction and inflammation, oxidative stress and inflammation Baseline and post 4 month No
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