Coronary Artery Disease
Conditions
Keywords
olive oil, myocardial deformation, glycocalyx
Brief summary
Olive extracts are considered to have antioxidant properties. The investigators will study the effect of olive extracts containing hydroxytyrosol (HT)-olivomed and combination of Oleuropein (OL), Hydroxytyrosol (HT), Oleocanthal (OC) - olivomedSmart on endothelial, cardiac and vascular function in patients with coronary artery disease .
Detailed description
30 patients with stable angiographically documented coronary artery disease will be randomized to receive olive extracts with high concentration of hydroxytyrosol (5 mg po twice per day included in Olivomed capsules) or placebo for one month and then they will be switched off to the alternate treatment (placebo or Olivomed capsules) for another one month. 30 patients with stable angiographically documented coronary artery disease will be randomized to receive OlivomedSmart - olive extracts with Oleuropein (OL), Hydroxytyrosol (HT), Oleocanthal (OC) (OL:HT:OC 2:1:3) or placebo for one month and then they will be switched off to the alternate treatment (placebo or Olivomed capsules) for another one month. the same quantity of hydroxytyrosol was contained in two supplements.
Interventions
DIETARY_SUPPLEMENTOlivomed (capsules containing hydroxytyrosol)
patients with stable coronary artery disease will be randomised to Olivomed or placebo for one month and then they will be crossed over to the alternate treatment for one month.
DIETARY_SUPPLEMENTOlivomedSmart - Capsules containing - combination of Oleuropein (OL), Hydroxytyrosol (HT), Oleocanthal (OC) - (OL:HT:OC 2:1:3), (5 mg HT bid).
patients with stable coronary artery disease will be randomised to combination of OL, HT, OC or placebo for one month and then they will be crossed over to the alternate treatment for one month.
Sponsors
University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
30 patients will be randomized to Olivomed (5 mg hydroxytyrosol po twice daily) or placebo for one month and then they will be crossed over to the alternate treatment for another one month. 30 patients will be randomized to OlivomedSmart ((OL:HT:OC 2:1:3) - 5 mg hydroxytyrosol po twice daily) or placebo for one month and then they will be crossed over to the alternate treatment for another one month.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age \<70 years 2. Stable coronary heart disease 3. 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 4. High LDL levels, low HDL, high triglycerides
Exclusion criteria
1. Age\> 70 years 2. Patient with diabetes 3. Patient with hypertension 4. Patient with liver disease 5. Patient with thyroid disease 6. Patient with active malignancy 7. Patient with a disease that affects inflammatory markers (rheumatic diseases, etc.) 8. Patient with chronic renal failure (creatinine\> 2 mg / dl) 9. Patient treated chronically with corticosteroids 10. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Olivomed and OlivomedSmart effects on endothelial glycocalyx thickness. | one month | Olivomed and OlivomedSmart effects on endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels using Sidestream Darkfield (SDF) imaging |
| Olivomed and OlivomedSmart effects on endothelial function. | one month | Olivomed and OlivomedSmarteffects 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. |
| Olivomed and OlivomedSmart effects on arterial stiffness | one month | Olivomed and OlivomedSmart effects on on arterial stiffness as assessed by carotid to femoral pulse wave velocity (PWV, m/s) using tonometry. |
| Olivomed and OlivomedSmarteffects on coronary function. | one month | Olivomed and OlivomedSmart 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. |
| Olivomed and OlivomedSmart effects on left ventricular function. | one month | Olivomed and OlivomedSmart effects on left ventricular function as assessed by Global Longitudinal Strain using speckle tracking echocardiography. |
Countries
Greece
Contacts
Primary ContactIgnatios Ikonomidis
Backup ContactKonstantinos Katogiannis
Outcome results
None listed