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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04520126
Recruitment Status : Not yet recruiting
First Posted : August 20, 2020
Last Update Posted : November 6, 2020
Sponsor:
Information provided by (Responsible Party):
Ignatios Ikonomidis, University of Athens

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) Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine


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 Name: 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 Name: placebo soft capsules




Primary Outcome Measures :
  1. Olivomed effects on endothelial glycocalyx thickness. [ Time Frame: 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

  2. Olivomed effects on endothelial function. [ Time Frame: 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.

  3. Olivomed effects on arterial stiffness [ Time Frame: three months ]
    Olivomed effects on on arterial stiffness as assessed by carotid to femoral pulse wave velocity (PWV, m/s) using tonometry.

  4. Olivomed effects on coronary function. [ Time Frame: 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.

  5. Olivomed effects on left ventricular function. [ Time Frame: three months ]
    Olivomed effects on left ventricular function as assessed by Global Longitudinal Strain using speckle tracking echocardiography.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04520126


Contacts
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Contact: Ignatios Ikonomidis +302105832187 ignoik@gmail.com
Contact: Konstantinos Katogiannis +306938165687 kenndj89@gmail.com

Locations
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Greece
"Attikon" University General Hospital
Athens, Attiki, Greece, 12462
Sponsors and Collaborators
University of Athens
Investigators
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Principal Investigator: Ignatios Ikonomidis 2nd Cardiology Department Of National and Kapodistrian University of Athens, Attikon General Hospital
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Responsible Party: Ignatios Ikonomidis, Associate Professor of Cardiology, University of Athens
ClinicalTrials.gov Identifier: NCT04520126    
Other Study ID Numbers: Oliveheart
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ignatios Ikonomidis, University of Athens:
olive oil, myocardial deformation, glycocalyx
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
3,4-dihydroxyphenylethanol
Anti-Infective Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Platelet Aggregation Inhibitors