Effect of Olivomed (Olive Extract) on Endothelial, Cardiac and Vascular Function

Study Overview
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Brief Summary
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Olive extracts are considered to have antioxidant properties. The investigators will study the effect of olive extracts containing hydroxytyrosol on endothelial, cardiac and vascular function in patients with coronary artery disease .

Detailed Description
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30 patients with stable angiographically documented coronary artery disease will be randomized to receive olive extracts with high concentration of hydroxytyrosol (10 mg po twice per day included in Olivomed capsules) or placebo for three months and then they will be switched off to the alternate treatment (placebo or Olivomed capsules) for another 3 months

Official Title
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Effect of Olivomed (Olive Extract) on Endothelial, Cardiac and Vascular Function of Patients With Stable Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Dietary Supplement: Olivomed (capsules containing hydroxytyrosol)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age <70 years Stable coronary heart disease Patients with acute coronary syndrome who have undergone percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), 2 months must have passed since the incident High LDL levels, low HDL, high triglycerides Exclusion Criteria: Age> 70 years Patient with diabetes Patient with hypertension Patient with liver disease Patient with thyroid disease Patient with active malignancy Patient with a disease that affects inflammatory markers (rheumatic diseases, etc.) Patient with chronic renal failure (creatinine> 2 mg / dl) Patient treated chronically with corticosteroids Patient who has joined a weight loss program or any dietary intervention or intensive exercise programme within the previous 2 months or consumes multivitamin preparations with antioxidant properties.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 30 patients will be randomized to Olivomed (10 mg hydroxytyrosol po twice daily) or placebo for three months and then they will be crossed over to the alternate treatment for another 3 months.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: olive extract 1<br>Fifteen patients will be randomized to receive two Olivomed soft capsules bid for three months (10 mg hydroxytyrosol po twice daily) and then they will be crossed over to treatment placebo for another 3 months. | Dietary Supplement: Olivomed (capsules containing hydroxytyrosol)<br>* patients with stable coronary artery disease will be randomised to Olivomed or placebo for three months and then they will be crossed over to the alternate treatment for three months.<br>* Other names: placebo soft capsules;|
| Placebo Comparator: placebo 2<br>Fifteen patients will be randomized to receive two placebo soft capsules bid for three months. Then they will be crossed over to receive two Olivomed soft capsules bid for three months (10 mg hydroxytyrosol po twice daily) | Dietary Supplement: Olivomed (capsules containing hydroxytyrosol)<br>* patients with stable coronary artery disease will be randomised to Olivomed or placebo for three months and then they will be crossed over to the alternate treatment for three months.<br>* Other names: placebo soft capsules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Olivomed effects on endothelial glycocalyx thickness. | Olivomed effects on endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels using Sidestream Darkfield (SDF) imaging | three months | 
| Olivomed effects on endothelial function. | Olivomed effects on endothelial function. Endothelial function is assessed by measuring Flow Mediated Vasodilation (FMD) of the brachial artery using ultrasonography. During FMD test, vasodilation occurs following an acute increase in blood flow, typically induced via circulatory arrest in the arm (supra-systolic cuff occlusion) for 5 minutes. FMD is the percent of increase of the brachial artery diameter during hyperemia after release of the occlusion. | three months | 
| Olivomed effects on arterial stiffness | Olivomed effects on on arterial stiffness as assessed by carotid to femoral pulse wave velocity (PWV, m/s) using tonometry. | three months | 
| Olivomed effects on coronary function. | Olivomed effects on coronary function as assessed by measuring coronary flow reserve of Left anterior descending artery. Coronary flow reserve is estimated by Doppler echocardiography as the ratio of coronary flow velocity after bolus intravenous adenosine infusion to coronary flow velocity at rest. | three months | 
| Olivomed effects on left ventricular function. | Olivomed effects on left ventricular function as assessed by Global Longitudinal Strain using speckle tracking echocardiography. | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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olive oil, myocardial deformation, glycocalyx