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

ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Athens

About this trial

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 .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age> 70 years

Patient with diabetes

Patient with hypertension

Patient with liver disease

Trial design

Design model

Crossover

Treatments tested in this trial

  • Olivomed (capsules containing hydroxytyrosol)

    Dietary supplement

    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.

  • OlivomedSmart - Capsules containing - combination of Oleuropein (OL), Hydroxytyrosol (HT), Oleocanthal (OC) - (OL:HT:OC 2:1:3), (5 mg HT bid).

    Dietary supplement

    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.

Treatment groups

30 Participants
are divided into 4 treatment groups
Group A: olive extract 1 - olivomedActive comparator 2 interventions
Group B: placebo 1Placebo comparator 2 interventions
Group C: olive extract 2 - olivomedSmartActive comparator 2 interventions
Group D: placebo2Placebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Olivomed and OlivomedSmart effects on endothelial glycocalyx thickness.

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

Time frame
one month
2

Olivomed and OlivomedSmart effects on endothelial function.

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.

Time frame
one month
3

Olivomed and OlivomedSmart effects on arterial stiffness

Olivomed and OlivomedSmart effects on on arterial stiffness as assessed by carotid to femoral pulse wave velocity (PWV, m/s) using tonometry.

Time frame
one month
4

Olivomed and OlivomedSmarteffects on coronary function.

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.

Time frame
one month

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Athens

Lead sponsor

Source ClinicalTrials.gov
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