Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 .
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| olive extract 1 - olivomed | Active Comparator | 15 patients will be randomized to receive two Olivomed soft capsules bid for one month (5 mg hydroxytyrosol po twice daily) and then they will be crossed over to treatment placebo for another one month. |
|
| placebo 1 | Placebo Comparator | 15 patients will be randomized to receive two placebo soft capsules bid for one month. Then they will be crossed over to receive two Olivomed soft capsules bid for oen month (5 mg hydroxytyrosol po twice daily) |
|
| olive extract 2 - olivomedSmart | Active Comparator | 15 patients will be randomized to receive two soft capsules containing OL:HT:OC (2:1:3) bid for one month (5 mg hydroxytyrosol po twice daily) and then they will be crossed over to treatment placebo for another one month. |
|
| placebo2 | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olivomed (capsules containing hydroxytyrosol) | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Olivomed and OlivomedSmart effects on endothelial glycocalyx thickness. | 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 | one month |
| Olivomed and OlivomedSmart effects on endothelial function. | 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. | one month |
| Olivomed and OlivomedSmart effects on arterial stiffness | Olivomed and OlivomedSmart effects on on arterial stiffness as assessed by carotid to femoral pulse wave velocity (PWV, m/s) using tonometry. | one month |
| Olivomed and OlivomedSmarteffects on coronary function. | 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. | one month |
| Olivomed and OlivomedSmart effects on left ventricular function. | Olivomed and OlivomedSmart effects on left ventricular function as assessed by Global Longitudinal Strain using speckle tracking echocardiography. | one month |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ignatios Ikonomidis | Contact | +302105832187 | ignoik@gmail.com | |
| Konstantinos Katogiannis | Contact | +306938165687 | kenndj89@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ignatios Ikonomidis | 2nd Cardiology Department, National and Kapodistrian University of Athens, Attikon General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Attikon" University General Hospital | Recruiting | Athens | Attica | 12462 | Greece |
Not provided
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.
Not provided
Not provided
Not provided
15 patients will be randomized to receive two placebo soft capsules bid for one month. Then they will be crossed over to receive two soft capsules containing OL:HT:OC (2:1:3) bid for one month (5 mg hydroxytyrosol po twice daily) bid for one month.
|
|
| OlivomedSmart - Capsules containing - combination of Oleuropein (OL), Hydroxytyrosol (HT), Oleocanthal (OC) - (OL:HT:OC 2:1:3), (5 mg HT bid). | Dietary Supplement | 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. |
|
|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C005975 | 3,4-dihydroxyphenylethanol |
| C503534 | oleocanthal |
Not provided
Not provided
Not provided