"Attikon" University General Hospital
Athens, Attica, 12462, Greece
Location status: Recruiting
Recruiting
NCT Number: NCT04520126
Effect of Olivomed (Olive Extract) on Endothelial, Cardiac and Vascular Function
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 .
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Olivomed (capsules containing hydroxytyrosol)
Dietary Supplementpatients 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.
Other names: placebo soft capsules
OlivomedSmart - Capsules containing - combination of Oleuropein (OL), Hydroxytyrosol (HT), Oleocanthal (OC) - (OL:HT:OC 2:1:3), (5 mg HT bid).
Dietary Supplementpatients 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.
Other names: placebo soft capsules
Primary outcomes
-
Olivomed and OlivomedSmart effects on endothelial glycocalyx thickness.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: one month
Olivomed and OlivomedSmart effects on left ventricular function as assessed by Global Longitudinal Strain using speckle tracking echocardiography.
Study contacts
Contact information is provided by the study sponsor or research team.
Ignatios Ikonomidis
CONTACT
Konstantinos Katogiannis
CONTACT
Sponsors and collaborators
Lead sponsor
University of Athens
Other
Registry information
Official study title
Effect of Olivomed (Olive Extract) on Endothelial, Cardiac and Vascular Function of Patients With Stable Coronary Artery Disease
Important dates
- Study start
- 2020
- Primary completion
- 2025
- Study completion
- 2026
- First posted
- Aug 20, 2020
- Registry last updated
- May 29, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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