Back to resultsEffect of Olivomed (Olive Extract) on Endothelial, Cardiac and Vascular Function
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Olivomed (capsules containing hydroxytyrosol)
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease focused on measuring olive oil, myocardial deformation, glycocalyx
Eligibility Criteria
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.
Sites / Locations
- "Attikon" University General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
olive extract 1
placebo 2
Arm Description
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.
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)
Outcomes
Primary Outcome Measures
Olivomed effects on endothelial glycocalyx thickness.
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.
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
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.
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.
Olivomed effects on left ventricular function as assessed by Global Longitudinal Strain using speckle tracking echocardiography.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04520126
Brief Title
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
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Anticipated)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Athens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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 .
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
olive oil, myocardial deformation, glycocalyx
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
olive extract 1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
placebo 2
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Olivomed (capsules containing hydroxytyrosol)
Other Intervention Name(s)
placebo soft capsules
Intervention Description
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.
Primary Outcome Measure Information:
Title
Olivomed effects on endothelial glycocalyx thickness.
Description
Olivomed effects on endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels using Sidestream Darkfield (SDF) imaging
Time Frame
three months
Title
Olivomed effects on endothelial function.
Description
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.
Time Frame
three months
Title
Olivomed effects on arterial stiffness
Description
Olivomed effects on on arterial stiffness as assessed by carotid to femoral pulse wave velocity (PWV, m/s) using tonometry.
Time Frame
three months
Title
Olivomed effects on coronary function.
Description
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.
Time Frame
three months
Title
Olivomed effects on left ventricular function.
Description
Olivomed effects on left ventricular function as assessed by Global Longitudinal Strain using speckle tracking echocardiography.
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ignatios Ikonomidis
Phone
+302105832187
Email
ignoik@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Konstantinos Katogiannis
Phone
+306938165687
Email
kenndj89@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ignatios Ikonomidis
Organizational Affiliation
2nd Cardiology Department Of National and Kapodistrian University of Athens, Attikon General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
"Attikon" University General Hospital
City
Athens
State/Province
Attiki
ZIP/Postal Code
12462
Country
Greece
12. IPD Sharing Statement
Learn more about this trial
Effect of Olivomed (Olive Extract) on Endothelial, Cardiac and Vascular Function
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