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

January 3, 2024 updated by: Ignatios Ikonomidis, University of Athens

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

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 .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
    • Attiki
      • Athens, Attiki, Greece, 12462
        • Recruiting
        • "ATTIKON" University General Hospital
        • Contact:
          • Ignatios Ikonomidis, MD
          • Phone Number: 00302105832187
        • Principal Investigator:
          • Ignatios Ikonomidis, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: olive extract 1 - olivomed
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.
Dietary supplement: Olivomed (capsules containing hydroxytyrosol)
patients 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
Dietary supplement: OlivomedSmart - Capsules containing - combination of Oleuropein (OL), Hydroxytyrosol (HT), Oleocanthal (OC) - (OL:HT:OC 2:1:3), (5 mg HT bid).
patients 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
Placebo Comparator: placebo 1
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)
Dietary supplement: Olivomed (capsules containing hydroxytyrosol)
patients 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
Dietary supplement: OlivomedSmart - Capsules containing - combination of Oleuropein (OL), Hydroxytyrosol (HT), Oleocanthal (OC) - (OL:HT:OC 2:1:3), (5 mg HT bid).
patients 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
Active Comparator: olive extract 2 - olivomedSmart
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.
Dietary supplement: Olivomed (capsules containing hydroxytyrosol)
patients 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
Dietary supplement: OlivomedSmart - Capsules containing - combination of Oleuropein (OL), Hydroxytyrosol (HT), Oleocanthal (OC) - (OL:HT:OC 2:1:3), (5 mg HT bid).
patients 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
Placebo Comparator: placebo2
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.
Dietary supplement: Olivomed (capsules containing hydroxytyrosol)
patients 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
Dietary supplement: OlivomedSmart - Capsules containing - combination of Oleuropein (OL), Hydroxytyrosol (HT), Oleocanthal (OC) - (OL:HT:OC 2:1:3), (5 mg HT bid).
patients 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one month
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.
one month
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.
one month
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.
one month
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.
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Athens

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Estimated)

January 10, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

August 17, 2020

First Submitted That Met QC Criteria

August 19, 2020

First Posted (Actual)

August 20, 2020

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Oliveheart

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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