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

NCT ID: NCT04520126

Last Updated: 2024-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2026-08-01

Brief Summary

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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 .

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Olivomed (capsules containing hydroxytyrosol)

Intervention Type 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).

Intervention Type 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.

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)

Group Type PLACEBO_COMPARATOR

Olivomed (capsules containing hydroxytyrosol)

Intervention Type 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).

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Olivomed (capsules containing hydroxytyrosol)

Intervention Type 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).

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Olivomed (capsules containing hydroxytyrosol)

Intervention Type 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).

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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placebo soft capsules placebo soft capsules

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Ignatios Ikonomidis

Professor of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ignatios Ikonomidis

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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"Attikon" University General Hospital

Athens, Attica, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Ignatios Ikonomidis

Role: CONTACT

+302105832187

Konstantinos Katogiannis

Role: CONTACT

+306938165687

Facility Contacts

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Ignatios Ikonomidis, MD

Role: primary

00302105832187

Other Identifiers

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Oliveheart

Identifier Type: -

Identifier Source: org_study_id

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