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OpenTrials
Completed

NCT Number: NCT00865787

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

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Marys Hospital

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Olivi Agri Team Srl- Grosetto, Italy
  • University of Florence

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 19, 2009
Registry last updated
Aug 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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