Clinical trial NCT02902913
Conditions: Cardiovascular Diseases
Keywords: platelet reactivity phenolic extra virgin olive oil cyclooxygenase oleocanthal oxylipin
Sponsor: University of California, Davis
Start date: 2015-01-01; Completion date: 2015-09-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

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.

Arms: arm 1: Oleocanthal-rich, D2i2 (Extra virgin olive oil containing oleocanthal to oleacein in a 2:1 ratio) arm 2: Oleacein-rich, D2i0.5 (Extra virgin olive oil containing oleocanthal to oleacein in a 1:2 ratio) arm 3: 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) arm 4: Ibuprofen, 400 mg
Interventions: intervention 1: D2i2 intervention 2: D2i0.5 intervention 3: D2i0 intervention 4: Ibuprofen
Intervention descriptions: intervention 1: Oleocanthal provided in a 2:1 ratio compared to oleacein intervention 2: Oleocanthal provided in a 1:2 ratio compared to oleacein intervention 3: No oleocanthal and no oleacein intervention 4: 400 mg of Ibuprofen

Protocol documents: