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

NCT07784166 | Active Not Recruiting

• 2 other identifiers: DUTh/EC/16218/176, 26-10-2025KE83656
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Antiplatelet; Antithrombotic; Anti-Inflammatory Agents, Non-Steroidal

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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

• 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

  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

• 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.

  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

Study Arms (4)

1st arm: 18 healthy volunteers consumed 30 mL of extra virgin olive oil (EVOO) daily for 28 days

EXPERIMENTAL

Other: Olive Oil 1

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

ACTIVE COMPARATOR

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 28d

EXPERIMENTAL

Other: Olive Oil 2

4th arm, 9 subjects consume 30 mL CTOO/d for 28d. After washout & crossover 30 mL of EVOO/d for 28d

ACTIVE COMPARATOR

Other: Olive oil (placebo) 2

Interventions

Olive Oil 1 OTHER

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

Also known as: 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

Olive oil (placebo) 1 OTHER

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

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

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

Olive Oil 2 OTHER

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

Also known as: single blinded, randomised, crossover, dietary intervention

3rd arm, 9 subjects consume 30 mL EVOO/d for 28d. After washout & crossover 30 mL of CTOO/d for 28d

Olive oil (placebo) 2 OTHER

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

Also known as: Dietary Intervnention, Crossover, Single Blinded, Randomised

4th arm, 9 subjects consume 30 mL CTOO/d for 28d. After washout & crossover 30 mL of EVOO/d for 28d

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Democritus University of Thrace: lead

Study Sites (1)

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

Kavala, 65404, Greece

Location

Related Publications (4)

• 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

  BACKGROUND

• 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.

  PMID: 35237975 BACKGROUND

• 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.

  PMID: 30619728 BACKGROUND

• 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.

  PMID: 40871671 BACKGROUND

MeSH Terms

Interventions

Diet Therapy; Economics; Olive Oil; Crossing Over, Genetic

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics; Health Care Economics and Organizations; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Homologous Recombination; Recombination, Genetic; Genetic Phenomena

Study Officials

• Alexandros Tsoupras

  Democritus University of Thrace

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blinded. The volunteers did not know what type of olive oil they were consuming during each period of the study, as the samples of olive oil were provided to them in similar bottles without any visionable differences
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 25, 2026
• Study Start: November 1, 2025
• Primary Completion: September 30, 2026
• Study Completion: September 30, 2026
• Last Updated: August 25, 2026

Record last verified: 2026-08

Locations

GR (1)