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

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease
• Interventions: Dietary Supplement: Olivomed (capsules containing hydroxytyrosol)

• Registration Number: NCT04520126
• Lead Sponsor: University of Athens

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.

Study Timeline

• Study First Submitted: 2020-08-17
• Study First Submitted QC: 2020-08-19
• Study First Posted: 2020-08-20
• Study Start: 2020-12-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-29
• Primary Completion: 2025-04-10
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo 1	Olivomed (capsules containing hydroxytyrosol)	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)
placebo2	Olivomed (capsules containing hydroxytyrosol)	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.
olive extract 1 - olivomed	Olivomed (capsules containing hydroxytyrosol)	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.
olive extract 2 - olivomedSmart	Olivomed (capsules containing hydroxytyrosol)	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.

Primary Outcome Measures

Name	Time	Method
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 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 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 left ventricular function.	one month	Olivomed and OlivomedSmart effects on left ventricular function as assessed by Global Longitudinal Strain using speckle tracking echocardiography.
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.

Trial Locations

Locations (1)

"Attikon" University General Hospital; 🇬🇷 Athens, Attiki, Greece