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

National and Kapodistrian University of Athens

Status: Enrolling

Conditions: Coronary Artery Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04520126

Oliveheart

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 4 patient groups, including a placebo group

olive extract 1 - olivomed

Active Comparator group

Description:

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.

Treatment:

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 group

Description:

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)

Treatment:

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 group

Description:

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.

Treatment:

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 group

Description:

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.

Treatment:

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).