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

Sponsor

University of Athens (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04520126

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 .

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Dietary Supplement: Olivomed (capsules containing hydroxytyrosol)	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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.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 (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: olive extract 1 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) 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. Other Names: placebo soft capsules
Placebo Comparator: placebo 2 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) 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. Other Names: placebo soft capsules

Arm

Intervention/Treatment

Active Comparator: olive extract 1

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)

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.

Other Names:

placebo soft capsules

Placebo Comparator: placebo 2

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)

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.

Other Names:

placebo soft capsules

Outcome Measures

Primary Outcome Measures

Olivomed effects on endothelial glycocalyx thickness. [three months]
Olivomed effects on endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels using Sidestream Darkfield (SDF) imaging
Olivomed effects on endothelial function. [three months]
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.
Olivomed effects on arterial stiffness [three months]
Olivomed effects on on arterial stiffness as assessed by carotid to femoral pulse wave velocity (PWV, m/s) using tonometry.
Olivomed effects on coronary function. [three months]
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.
Olivomed effects on left ventricular function. [three months]
Olivomed effects on left ventricular function as assessed by Global Longitudinal Strain using speckle tracking echocardiography.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	"Attikon" University General Hospital	Athens	Attiki	Greece	12462

Sponsors and Collaborators

University of Athens

Investigators

Principal Investigator: Ignatios Ikonomidis, 2nd Cardiology Department Of National and Kapodistrian University of Athens, Attikon General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ignatios Ikonomidis, Associate Professor of Cardiology, University of Athens

ClinicalTrials.gov Identifier:

NCT04520126

Other Study ID Numbers:

Oliveheart

First Posted:

Aug 20, 2020

Last Update Posted:

Nov 6, 2020

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ignatios Ikonomidis, Associate Professor of Cardiology, University of Athens

olive oil, myocardial deformation, glycocalyx

Additional relevant MeSH terms:

Coronary Artery Disease

Myocardial Ischemia

Coronary Disease

3,4-dihydroxyphenylethanol

Study Results

No Results Posted as of Nov 6, 2020