Impact of Extra Virgin Olive Oil Oleocanthal Content on Platelet Reactivity

University of California (UC) Davis

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Drug: Ibuprofen; Other: D2i0.5; Other: D2i2; Other: D2i0

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02902913

617247

Details and patient eligibility

About

Data from limited dietary intervention trials suggest that the cardiovascular health benefit of extra virgin olive oil (EVOO) may increase with phenolic content. However, while EVOOs contain an array of bioactive compounds, little information exists regarding the physiological effects of specific chemical species. Among the EVOO-derived phenolics with demonstrated anti-inflammatory effects in animal and in vitro models is oleocanthal, an inhibitor of cyclooxygenase (COX). The current study compared the impact of acute intake (40 mL) of EVOO on platelet reactivity in healthy adult males (n=9). The volunteers were randomly assigned to consume three EVOOs in a double-blind controlled trial. The EVOO were characterized and chosen for equivalency in their total phenolic content and fatty acid profiles, but differing in their oleocanthal to oleacein ratio.

Full description

Ten healthy adult males (20-50 years of age) will be enrolled into a randomized triple-blind, controlled crossover study that will test the acute effects of oleocanthal-rich extra virgin olive oil intake on platelet aggregation. Each participant will be asked to participate in four study days, separated by at least 1-week, in which they will be randomized to consume on each study day 40 mL (~3 tablespoons) of either oleocanthal-rich extra virgin olive oil (OO), or an extra virgin OO that is matched in total phenolics but oleocanthal-poor, or a refined OO that is low in all phenolics In addition to the oils, on a fourth study day visit, after completion of the study visits involving oil intake the subjects will be asked to take 400mg of ibuprofen.

Collection procedures will be performed at the same time of the day to avoid circadian effects. A blood sample (50 mL ~ 3.5 tbsp) will be collected for the measurement of platelet aggregometry and COX metabolites. Following this initial blood draw, the subjects will consume their assigned test product for the day. Two-hours following the intake of the assigned olive oil, a second blood sample will be drawn (50 mL ~ 3.5 tbsp). After the second blood draw, the study day will be complete.

Enrollment: 9 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Willing and able to comply with study protocols
• Willing to drink 2 tablespoons of olive oil
• BMI 18.5 to 30 kg/m2
• Weight ≥ 110 pounds

Exclusion criteria

• Adults who are not able to consent
• BMI ≥ 31 kg/m2
• Under current medical supervision
• Self-reported daily use of drugs that are known to affect platelet function, such as aspirin, Excedrin, and NSAIDS
• Ibuprofen intolerance or allergy
• Cannot speak English
• Allergy to olives or olive oil
• Vegetarian, Vegan, food faddists, individuals using non-traditional diets, on a weight loss diet or individual following diets with significant deviations from the average diet of the general population.
• A history of cardiovascular disease, stroke, cancer, renal, hepatic, or thyroid disease, GI tract disorders, previous GI surgery
• Currently taking prescription drugs or supplements
• Indications of substance or alcohol abuse within the last 3 years
• Not willing to stop any supplement use, including herbal, plant or botanical, fish oil, oil supplements.
• Not willing to refrain from olive oil consumption.
• Blood Pressure ≥ 140/90 mmHg
• Self-reported malabsorption
• Metabolic panel results or complete blood counts that are outside of the normal reference range.
• Screening LDL ≥ 190 mg/dl for those who have 0 - 1 major risk factors apart from LDL cholesterol [(i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL].
• Screening LDL ≥ 160 mg/dl for those who have 2 major risk factors apart from LDL cholesterol [(i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL].
• Screening LDL ≥ than 130 mg/dl for those who have 2 major risk factors apart from LDL cholesterol ((i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL), and a Framingham 10 - year Risk Score 10 - 20 % (using NCEP calculator).
• Current enrollee in a clinical research study.
• Individuals with blood clotting or platelet defect disorders

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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9 participants in 4 patient groups, including a placebo group

Oleocanthal-rich, D2i2

Experimental group

Description:

Oleocanthal-rich, D2i2 (Extra virgin olive oil containing oleocanthal to oleacein in a 2:1 ratio)

Treatment:

Other: D2i2

Oleacein-rich, D2i0.5

Experimental group

Description:

Oleacein-rich, D2i0.5 (Extra virgin olive oil containing oleocanthal to oleacein in a 1:2 ratio)

Treatment:

Other: D2i0.5

Oleocanthal and Oleacein-low, D2i0

Placebo Comparator group

Description:

Oleocanthal and Oleacein-low, D2i0 (Extra virgin olive oil containing low amounts of oleocanthal to oleacein, but with a similar total phenolic content as the other two oils)

Treatment:

Other: D2i0

Ibuprofen

Active Comparator group

Description:

Ibuprofen, 400 mg

Treatment:

Drug: Ibuprofen