Impact of Extra Virgin Olive Oil Oleocanthal Content on Platelet Reactivity

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

All participants received all four interventions in a randomized, cross-over design in which both participant and caregiver were masked to the assignment (with the exception of the fourth intervention, ibuprofen, which was always administered at the final study visit).

Study Groups

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Oleocanthal-rich, D2i2

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

Group Type EXPERIMENTAL

D2i2

Intervention Type OTHER

Oleocanthal provided in a 2:1 ratio compared to oleacein

Oleacein-rich, D2i0.5

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

Group Type EXPERIMENTAL

D2i0.5

Intervention Type OTHER

Oleocanthal provided in a 1:2 ratio compared to oleacein

Oleocanthal and Oleacein-low, D2i0

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)

Group Type PLACEBO_COMPARATOR

D2i0

Intervention Type OTHER

No oleocanthal and no oleacein

Ibuprofen

Ibuprofen, 400 mg

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

400 mg of Ibuprofen

Interventions

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D2i2

Oleocanthal provided in a 2:1 ratio compared to oleacein

Intervention Type OTHER

D2i0.5

Oleocanthal provided in a 1:2 ratio compared to oleacein

Intervention Type OTHER

D2i0

No oleocanthal and no oleacein

Intervention Type OTHER

Ibuprofen

400 mg of Ibuprofen

Intervention Type DRUG

Other Intervention Names

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Oleocanthal-rich Oleocanthal-low Control EVOO

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes