D2i2
OtherOleocanthal provided in a 2:1 ratio compared to oleacein
Other names: Oleocanthal-rich
NCT Number: NCT02902913
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.
Looking for future studies?
Notify Me20 year–50 year
Male
Interventional
Not applicable
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oleocanthal provided in a 2:1 ratio compared to oleacein
Other names: Oleocanthal-rich
Oleocanthal provided in a 1:2 ratio compared to oleacein
Other names: Oleocanthal-low
No oleocanthal and no oleacein
Other names: Control EVOO
400 mg of Ibuprofen
Time frame: Change from baseline 2 hours post intake
Maximal platelet aggregation in minutes will be measured using optical platelet aggregometry
Time frame: Change 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.
University of California, Davis
Other
Impact of Extra Virgin Olive Oil Oleocanthal Content on Platelet Reactivity in Healthy Humans
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03188705
Arterial Occlusive Diseases, Arteriosclerosis
Lancaster, Pennsylvania, United States
View Trial DetailsNCT05882045
Body Weight, Cardiovascular Diseases
Phoenix, Arizona, United States
View Trial DetailsNCT02439775
Cardiovascular Diseases, Hypertension
Huntsville, Alabama, United States
View Trial DetailsNCT05820295
Arrhythmias, Cardiac, Atrial Fibrillation
New York, United States
View Trial Details