Clinical trial NCT04520126: Effect of Olivomed (Olive Extract) on Endothelial, Cardiac and Vascular Function
Official title: Effect of Olivomed (Olive Extract) on Endothelial, Cardiac and Vascular Function of Patients With Stable Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: olive oil, myocardial deformation, glycocalyx
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Olivomed and OlivomedSmart effects on endothelial glycocalyx thickness.
timeFrame: one month
measure: Olivomed and OlivomedSmart effects on endothelial function.
timeFrame: one month
measure: Olivomed and OlivomedSmart effects on arterial stiffness
timeFrame: one month
measure: Olivomed and OlivomedSmarteffects on coronary function.
timeFrame: one month
measure: Olivomed and OlivomedSmart effects on left ventricular function.
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: "Attikon" University General Hospital
state: Attiki
Study officials:
affiliation: 2nd Cardiology Department, National and Kapodistrian University of Athens, Attikon General Hospital
name: Ignatios Ikonomidis
role: PRINCIPAL_INVESTIGATOR
References: