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

NCT04520126 | Recruiting

• 1 other identifier: Oliveheart
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Coronary Artery Disease

Keywords

olive oil, myocardial deformation, glycocalyx

Outcome Measures

Primary Outcomes (5)

• 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

  one month

• 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.

  one month

• 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.

  one month

• 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.

  one month

• Olivomed and OlivomedSmart effects on left ventricular function.

  Olivomed and OlivomedSmart effects on left ventricular function as assessed by Global Longitudinal Strain using speckle tracking echocardiography.

  one month

Study Arms (4)

olive extract 1 - olivomed

ACTIVE COMPARATOR

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

placebo 1

PLACEBO COMPARATOR

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

olive extract 2 - olivomedSmart

ACTIVE COMPARATOR

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

placebo2

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: placebo soft capsules

olive extract 1 - olivomed; olive extract 2 - olivomedSmart; placebo 1; placebo2

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.

Also known as: placebo soft capsules

olive extract 1 - olivomed; olive extract 2 - olivomedSmart; placebo 1; placebo2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

"Attikon" University General Hospital

Athens, Attica, 12462, Greece

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

3,4-dihydroxyphenylethanol; oleocanthal

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ignatios Ikonomidis

  2nd Cardiology Department, National and Kapodistrian University of Athens, Attikon General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ignatios Ikonomidis

CONTACT

+302105832187; ignoik@gmail.com

Konstantinos Katogiannis

CONTACT

+306938165687; kenndj89@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology

Model Details: 30 patients will be randomized to Olivomed (5 mg hydroxytyrosol po twice daily) or placebo for one month and then they will be crossed over to the alternate treatment for another one month. 30 patients will be randomized to OlivomedSmart ((OL:HT:OC 2:1:3) - 5 mg hydroxytyrosol po twice daily) or placebo for one month and then they will be crossed over to the alternate treatment for another one month.

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 20, 2020
• Study Start: December 1, 2020
• Primary Completion: April 10, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

GR (1)