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
| Type | Name | Description |
|---|---|---|
| OTHER | Oleocanthal-Rich Extra Virgin Olive Oil | Extra Virgin Olive Oil that contains a high level of the phenolic oleocanthal |
| OTHER | Oleocanthal-low Extra Virgin Olive Oil | Extra 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.