Coronary Artery DiseaseNCT04520126
Effect of Olivomed (Olive Extract) on Endothelial, Cardiac and Vascular Function
A study testing Olivomed (capsules containing hydroxytyrosol) and OlivomedSmart - Capsules containing - combination of Oleuropein (OL), Hydroxytyrosol (HT), Oleocanthal (OC) - (OL:HT:OC 2:1:3), (5 mg HT bid). in people with Coronary Artery Disease, run by University of Athens at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Olivomed (capsules containing hydroxytyrosol) and OlivomedSmart - Capsules containing - combination of Oleuropein (OL), Hydroxytyrosol (HT), Oleocanthal (OC) - (OL:HT:OC 2:1:3), (5 mg HT bid).
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- 1 Dec 2020to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age> 70 years
- Patient with diabetes
- Patient with hypertension
- Patient with liver disease
- Patient with thyroid disease
- Patient with active malignancy
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- 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.
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
"Attikon" University General Hospital
Athens, Attica, 12462
Ignatios Ikonomidis, MD, 00302105832187
Ignatios Ikonomidis, MD
About this study
Official title: 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 .
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Olivomed (capsules containing hydroxytyrosol), OlivomedSmart - Capsules containing - combination of Oleuropein (OL), Hydroxytyrosol (HT), Oleocanthal (OC) - (OL:HT:OC 2:1:3), (5 mg HT bid).
- Keywords
- olive oil, myocardial deformation, glycocalyx
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olivomed (capsules containing hydroxytyrosol)Dietary supplement
Also called placebo soft capsules
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
Also called placebo soft capsules
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: 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. Receives: 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start1 Dec 2020
- Primary completion10 Apr 2025 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignatios Ikonomidis, University of Athens
- Investigators
- Ignatios Ikonomidis, Principal investigator, 2nd Cardiology Department, National and Kapodistrian University of Athens, Attikon General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520126
- Sponsor's protocol ID
- Oliveheart
- Status last verified
- May 2024
- First submitted
- 17 Aug 2020
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Olivomed (Olive Extract) on Endothelial, Cardiac and Vascular Function of Patients With Stable Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT04520126
- Acronym / sponsor ID
- Oliveheart
- Conditions
- Coronary Artery Disease
- Keywords
- olive oil, myocardial deformation, glycocalyx
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 10 Apr 2025 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 20 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| olive extract 1 - olivomed | Active comparator | 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).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. |
| placebo 1 | Placebo comparator | 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).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) |
| olive extract 2 - olivomedSmart | Active comparator | 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).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. |
| placebo2 | Placebo comparator | 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).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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Age> 70 years
- Patient with diabetes
- Patient with hypertension
- Patient with liver disease
- Patient with thyroid disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olivomed (capsules containing hydroxytyrosol)Also: placebo soft capsulespatients 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. | Dietary supplement | 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).Also: placebo soft capsulespatients 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. | Dietary supplement | olive extract 1 - olivomed, olive extract 2 - olivomedSmart, placebo 1, placebo2 |
Primary outcome
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
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ignatios Ikonomidis principal investigator
2nd Cardiology Department, National and Kapodistrian University of Athens, Attikon General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olivomed (capsules containing hydroxytyrosol) and OlivomedSmart - Capsules containing - combination of Oleuropein (OL), Hydroxytyrosol (HT), Oleocanthal (OC) - (OL:HT:OC 2:1:3), (5 mg HT bid). in people with Coronary Artery Disease, run by University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ignatios Ikonomidis (+302105832187, ignoik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Olivomed and OlivomedSmart effects on endothelial glycocalyx thickness. (time frame: one month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.