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AntiplateletHealthAgriloilNCT07784166

In Vivo Evaluation of Anti-inflammatory and Antithrombotic Health Promoting Properties of Extra Virgin Olive Oil Versus Classic Table Olive Oil in Healthy Subjects

A study testing Olive Oil 1 and Olive Oil 2 in people with Antiplatelet and Antithrombotic, run by Democritus University of Thrace at 1 site in Greece.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study aims to evaluate the in vivo antithrombotic and anti-inflammatory effects of extra virgin olive oil daily consumption at recommended doses for 1 month compared to similar consumption of classic table olive oil, in the blood plasma and platelets of healthy donors Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Olive Oil 1 and Olive Oil 2
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
1 siteGreece
Study dates
1 Nov 2025to 30 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Not to have a pathological condition related to platelet and leukocyte activity
  • Not to have a chronic pathological condition
  • To have a Normal Body Mass Index (BMI) and waist circumference
  • Not to take medications/supplements or any kind of other intervention that have anti-inflammatory and/or antithrombotic and/or antioxidant effects

Who cannot join

  • To have a pathological condition related to platelet and leukocyte activity
  • To have a chronic pathological condition
  • Not to have a Normal Body Mass Index (BMI) and waist circumference
  • To take medications/supplements/nutraceuticals or any kind of other intervention that have anti-inflammatory and/or antithrombotic and/or antioxidant effects

Trial locations and contacts

1 site in 1 country.

Greece1 site
  • Biochemistry Lab, Hephaestus Laboratory, School of Chemistry, Faculty of Sciences, Kavala University Campus, Democritus University of Thrace

    Kavala, 65404

Other trials in Greece

About this study

Official title: Study of the Anti-Inflammatory Health Benefits of "Argilos Extra Virgin Olive Oil" ("Healthy Argiloil")

This study aims to evaluate the in vivo antithrombotic and anti-inflammatory effects of extra virgin olive oil daily consumption at recommended doses for 1 month compared to similar consumption of classic table olive oil, in the blood plasma and platelets of healthy donors

Read the detailed description

Introduction: Thrombo-inflammatory manifestations are key pathophysiological mechanisms of cardiovascular diseases and are directly related to platelet activation and aggregation. Extra virgin olive oil, a key component of the Mediterranean diet, is rich in natural bioactives (e.g. unsaturated fatty acids, polar lipids, phenolic compounds, carotenoids and other pigments), which have been proposed to possess not only antioxidant activities, but mainly strong anti-inflammatory and antiplatelet properties, which contribute to the reduction of cardiovascular risk. However, to our knowledge, nutritional and biochemical evaluation of these properties through an in vivo intervention study has not been thoroughly conducted, especially for the cardioprotective benefits of consuming such an extra virgin olive oil against the main thrombo-inflammatory pathways, and compared to plain classic table olive oil.

Purpose: The purpose of this study was the qualitative characterization of a sample of extra virgin olive oil and the biochemical investigation of the effect of its daily consumption on platelet activation and on the mechanisms related to thrombo-inflammation compared to the effects observed by a similar consumption of classic table olive oil.

Materials and Methods: An in vivo dietary intervention study, randomised and single blinded (the volunteers did not know what type of olive oil they consumed) was performed on four arms:

In the 1st arm, 18 healthy volunteers consumed the nutritionally recommended daily dose (30 mL) of extra virgin olive oil daily for 28 days.

In the 2nd arm, 18 other healthy volunteers consumed the nutritionally recommended daily dose (30 mL) of plain classic table olive oil daily for 28 days.

In the 3rd arm, 9 healthy volunteers initially consumed the nutritionally recommended daily dose (30 mL) of extra virgin olive oil daily for 28 days and after a month washout period they then re-consumed the nutritionally recommended daily dose (30 mL) of plain classic table olive oil daily for another period of 28 days, in a crossover single blinded randomised design In the 4th arm, 9 healthy volunteers initially consumed the nutritionally recommended daily dose (30 mL) of plain classic table olive oil daily for 28 days and after a month washout period they then re-consumed the nutritionally recommended daily dose (30 mL) of extra virgin olive oil daily for another period of 28 days, in a crossover single blinded randomised design Blood samples were taken from all volunteers in all these 4 arms, on days 0 and 28 in each one of these interventions and platelet sensitization by various agonists was assessed just after blood sampling. Blood Plasma was stored at -20oC for further analysis Specifically the anti-inflammatory effects were expressed as the Effective Concentrations that induce 50% of platelet aggregation (EC50 values) by platelet-activating factor (PAF), the antithrombotic effects as the EC50 for Thrombin by using Thrombin Receptor Active Peptide (TRAP) and the antiplatelet effects as the EC50 values for ADP.

Being tested
Olive Oil 1, Olive oil (placebo) 1, Olive Oil 2, Olive oil (placebo) 2
Keywords
Anti-inflammatory, Antiplatelet, Antithrombotic, dietary intervention study, olive oil, platelet activating factor, thrombin, ADP, platelet aggregation, thrombo-inflammatory stimuli, Human Plasma, Human plasma rich in platelets, EC50 values, TEAC values, single blinded, crossover, randomized

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Olive Oil 1Other

    Also called Dietary Intervention, Extra virgin olive oil (EVOO) consumption, Single Blinded, Randomised

    1st arm: 18 healthy volunteers consumed 30 mL of extra virgin olive oil (EVOO) daily for 28 days. Blood samples and biochemical assays were conducted just before (day 0) and after (day 28) this dietary intervention

  • Olive oil (placebo) 1Other

    Also called randomised, single blinded, plain classic table olive oil (CTOO) consumption, dietary intervention

    2nd arm, 18 other healthy volunteers consumed 30 mL of plain classic table olive oil (CTOO) daily for 28 days.

  • Olive Oil 2Other

    Also called single blinded, randomised, crossover, dietary intervention

    3rd arm, 9 healthy volunteers initially consumed 30 mL of EVOO daily for 28 days and after a washout period of 1 month they then re-consumed 30 mL of CTOO daily for 28 days, in a crossover single blinded randomized design with the 3rd arm. Blood sampling and Biochemical Assays were conducted just before (day 0) and just after (day 28) each of these interventions

  • Olive oil (placebo) 2Other

    Also called Dietary Intervnention, Crossover, Single Blinded, Randomised

    4th arm, 9 healthy volunteers initially consumed 30 mL of CTOO daily for 28 days and after a washout period of 1 month they then re-consumed 30 mL of EVOO daily for 28 days, in a crossover single blinded randomized design with the 3rd arm. Blood sampling and Biochemical Assays were conducted just before (day 0) and just after (day 28) each of these interventions

Study groups in NCT07784166
Study groupRoleWhat they receive
1st arm: 18 healthy volunteers consumed 30 mL of extra virgin olive oil (EVOO) daily for 28 daysExperimentalNot described
Receives: Other: Olive Oil 1
2nd arm, 18 healthy volunteers consumed 30 mL of plain classic table olive oil (CTOO) daily for 28 dActive comparatorNot described
Receives: Other: Olive oil (placebo) 1
3rd arm, 9 subjects consume 30 mL EVOO/d for 28d. After washout & crossover 30 mL of CTOO/d for 28dExperimentalNot described
Receives: Other: Olive Oil 2
4th arm, 9 subjects consume 30 mL CTOO/d for 28d. After washout & crossover 30 mL of EVOO/d for 28dActive comparatorNot described
Receives: Other: Olive oil (placebo) 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effective Concentration of 50% of platelet aggregation (EC50 value) for PAF

    1. The anti-inflammatory effects of the intervention assessed in platelets and plasma of blood samples from all volunteers are expressed as the Effective Concentrations that induce 50% of platelet aggregation (EC50 values) induced by platelet-activating factor (PAF), measured in nM concentration of PAF that can cause 50% of platelet aggregation.

    Measured: Blood sampling and platelet sensitization by PAF is assessed just before (day 0) and just after (day 28) of each intervention in platelets and plasma of blood samples from all volunteers in all these 4 arms

  2. Effective Concentration of 50% of platelet aggregation (EC50 value) for Thrombin

    The antithrombotic effects of the intervention assessed in platelets and plasma of blood samples from all volunteers are expressed as the Effective Concentration that induce 50% of platelet aggregation (EC50 values) induced by the Thrombin Pathway, measured in μM concentration of Thrombin Receptor Active Peptide (TRAP) that can cause 50% of platelet aggregation

    Measured: Blood sampling and platelet sensitization by TRAP is assessed just before (day 0) and just after (day 28) of each intervention in platelets and plasma of blood samples from all volunteers in all these 4 arms

  3. Effective Concentration of 50% of platelet aggregation (EC50 value) for ADP

    The antiplatelet effects of the intervention assessed in platelets and plasma of blood samples from all volunteers are expressed as the Effective Concentration that induce 50% of platelet aggregation (EC50 values) induced by the Adenosine 5' Diphosphate (ADP, measured in μM concentration of ADP that can cause 50% of platelet aggregation.

    Measured: Blood sampling and platelet sensitization by ADP is assessed just before (day 0) and just after (day 28) of each intervention in platelets and plasma of blood samples from all volunteers in all these 4 arms

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2026
  2. Study start1 Nov 2025
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

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
in vivo dietary intervention study, randomised and single blinded with four arms: 1. st arm: 18 healthy volunteers consumed 30 mL of extra virgin olive oil (EVOO) daily for 28 days. 2. nd arm, 18 other healthy volunteers consumed 30 mL of plain classic table olive oil (CTOO) daily for 28 days. 3. rd arm, 9 healthy volunteers initially consumed 30 mL of EVOO daily for 28 days and after a washout period of 1 month they then re-consumed 30 mL of CTOO daily for 28 days, in a crossover single blinded randomised design with the 4th arm 4. th arm, 9 healthy volunteers initially consumed 30 mL of CTOO daily for 28 days and after a washout period of 1 month they then re-consumed 30 mL of EVOO daily for 28 days, in a crossover single blinded randomised design with the 3rd arm Biochemical assays for anti-inflammatory and antithrombotic effects were performed in platelets and plasma of blood samples from all volunteers at days 0 and 28 in each arm and intervention
Masking
Single blind
Who is masked
Participant
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07784166
Sponsor's protocol ID
DUTh/EC/16218/176, 26-10-2025
Other IDs
KE83656
Acronym
HealthAgriloil
Status last verified
Aug 2026
First submitted
4 Aug 2026
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: We might submit for publication all data and plan in an open access scientific journal, peer reviewed, in these fields of research

Publications

  • Sakshi Hans, Harishkumar Rajendran, Katie Shiels, Sushanta Kumar Saha, Alexandros Tsoupras, Ronan Lordan, Ioannis Zabetakis, The ex vivo and in vitro antithrombotic properties of fermented Irish ovine yogurt drink, in Proceedings of The 4th International Electronic Conference on Foods, 15 October-30 October 2023, MDPI: Basel, Switzerland, doi: 10.3390/Foods2023-15054

  • Lordan R, Tsoupras A, Zabetakis I. Investigation of Platelet Aggregation in Atherosclerosis. Methods Mol Biol. 2022;2419:333-347. doi: 10.1007/978-1-0716-1924-7_21.

    PubMed 35237975
  • Tsoupras A, Zabetakis I, Lordan R. Platelet aggregometry assay for evaluating the effects of platelet agonists and antiplatelet compounds on platelet function in vitro. MethodsX. 2018 Dec 26;6:63-70. doi: 10.1016/j.mex.2018.12.012. eCollection 2019.

    PubMed 30619728
  • Chrysikopoulou V, Rampaouni A, Koutsia E, Ofrydopoulou A, Mittas N, Tsoupras A. Anti-Inflammatory, Antithrombotic and Antioxidant Efficacy and Synergy of a High-Dose Vitamin C Supplement Enriched with a Low Dose of Bioflavonoids; In Vitro Assessment and In Vivo Evaluation Through a Clinical Study in Healthy Subjects. Nutrients. 2025 Aug 14;17(16):2643. doi: 10.3390/nu17162643.

    PubMed 40871671

Questions about this trial

What is this clinical trial studying?

A study testing Olive Oil 1 and Olive Oil 2 in people with Antiplatelet and Antithrombotic, run by Democritus University of Thrace 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 4 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: under way, not looking for participants, as of the sponsor's last update on 25 Aug 2026. 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. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effective Concentration of 50% of platelet aggregation (EC50 value) for PAF (time frame: Blood sampling and platelet sensitization by PAF is assessed just before (day 0) and just after (day 28) of each intervention in platelets and plasma of blood samples from all volunteers in all these 4 arms). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07784166, which also lists 4 linked publications.

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 25 Aug 2026.

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