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Impact of Extra Virgin Olive Oil Oleocanthal Content on Platelet Reactivity

Not Applicable
Completed
Conditions
Cardiovascular Diseases
Interventions
Other: D2i2
Other: D2i0.5
Other: D2i0
Registration Number
NCT02902913
Lead Sponsor
University of California, Davis
Brief Summary

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.

Detailed 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
9
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Oleocanthal-rich, D2i2D2i2Oleocanthal-rich, D2i2 (Extra virgin olive oil containing oleocanthal to oleacein in a 2:1 ratio)
Oleacein-rich, D2i0.5D2i0.5Oleacein-rich, D2i0.5 (Extra virgin olive oil containing oleocanthal to oleacein in a 1:2 ratio)
Oleocanthal and Oleacein-low, D2i0D2i0Oleocanthal 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)
IbuprofenIbuprofenIbuprofen, 400 mg
Primary Outcome Measures
NameTimeMethod
Optical Platelet AggregometryChange from baseline 2 hours post intake

Maximal platelet aggregation in minutes will be measured using optical platelet aggregometry

Secondary Outcome Measures
NameTimeMethod
Activated Platelet Oxylipin ProductionChange from baseline 2 hours post intake

Oxylipins derived from cyclooxygenase, lipoxygenase, and cytochrome P450 dependent metabolism of AA were quantified using liquid chromatography with tandem mass spectrometry (LC-MS/MS) in 100 µL of PRP plasma activated with collagen or ADP as well as 100 µL of unactivated PRP plasma collected before and two hours after treatment with EVOO or ibuprofen.

Data were mean centered and reported as a % change from baseline.

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