Clinical Trials Directory

Trials / Completed

CompletedNCT03528603

Acute Assessment of Platelet Reactivity After the Intake of Oleocanthal

Acute Assessment of Platelet Reactivity After the Intake of Oleocanthal From Extra Virgin Olive Oil in the Fasted and Fed Condition

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
26 (actual)
Sponsor
University of California, Davis · Academic / Other
Sex
Male
Age
20 Years – 45 Years
Healthy volunteers
Accepted

Summary

The investigators have previously observed a reduced level of platelet aggregation 2 hours after healthy male individuals were asked to drink extra virgin olive oil (EVOO) that provided a higher level of one specific phenolic known as oleocanthal. This study will help the investigators further determine the effects of oleocanthal-rich EVOO intake on platelet function at 2, 4 and 6 hours after intake with food compared to platelet function in the morning after an overnight fast.

Detailed description

Fifty adult male volunteers will be asked to participate in one of two study trials that will be randomized double-blind controlled crossover trials with 2 study visits. The participants will arrive to the facility after an overnight fast, and will be asked to consume their assigned EVOO either without (trial 1) or with (trial 2) a standardized low-phenolic food (such as rice, pasta or mashed potatoes) with 40 mL of one of 2 EVOOs that are matched for their total phenolic content, but with one oil containing oleocanthal, and one with very low levels of oleocanthal. At zero, two, 4 and 6 hours after EVOO intake a blood sample will be collected for the assessment of collagen- ADP-, and AA-induced platelet aggregation, as well as an untargeted metabolomics profile. As an assessment of phenotypic stability, a subset of individuals (n=5 per trial) that have exhibit either low or high platelet responses, will be asked to repeat the above study.

Conditions

Interventions

TypeNameDescription
OTHEROleocanthal-Rich Extra Virgin Olive OilExtra Virgin Olive Oil that contains a high level of the phenolic oleocanthal
OTHEROleocanthal-low Extra Virgin Olive OilExtra Virgin Olive Oil that contains a low level of the phenolic oleocanthal

Timeline

Start date
2018-04-02
Primary completion
2023-03-01
Completion
2024-05-31
First posted
2018-05-18
Last updated
2024-06-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03528603. Inclusion in this directory is not an endorsement.