Trial Outcomes & Findings for Impact of Extra Virgin Olive Oil Oleocanthal Content on Platelet Reactivity (NCT NCT02902913)

NCT ID: NCT02902913

Last Updated: 2021-04-27

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 9 participants
• Primary outcome timeframe: Change from baseline 2 hours post intake
• Results posted on: 2021-04-27

Participant Flow

Participant milestones

Measure	All Participants All participants received all four study interventions. The first three interventions were administered in random order: * Oleocanthal-rich, D2i2 * Oleacein-rich, D2i0.5 * Oleocanthal and Oleacein-low, D2i0 All participants received the last intervention, 400 mg of Ibuprofen, at the fourth (final) study visit.
Overall Study STARTED	9
Overall Study First Intervention (1 Day)	9
Overall Study Washout (7 Days)	9
Overall Study Second Intervention (1 Day)	9
Overall Study Third Intervention (1 Day)	9
Overall Study Ibuprofen (400mg)	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Extra Virgin Olive Oil Oleocanthal Content on Platelet Reactivity

Baseline characteristics by cohort

Measure	All Participants n=9 Participants All participants received all four study interventions. The first three interventions were administered in random order: * Oleocanthal-rich, D2i2 * Oleacein-rich, D2i0.5 * Oleocanthal and Oleacein-low, D2i0 All participants received the last intervention, 400 mg of Ibuprofen, at the fourth (final) study visit.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	26 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline 2 hours post intake

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

Outcome measures

Measure	All Participants n=9 Participants All participants received all four study interventions. The first three interventions were administered in random order: * Oleocanthal-rich, D2i2 * Oleacein-rich, D2i0.5 * Oleocanthal and Oleacein-low, D2i0 All participants received the last intervention, 400 mg of Ibuprofen, at the fourth (final) study visit.	Oleacein-rich, D2i0.5 Oleacein-rich, D2i0.5 (Extra virgin olive oil containing oleocanthal to oleacein in a 1:2 ratio) D2i0.5: Oleocanthal provided in a 1:2 ratio compared to oleacein	Oleocanthal and Oleacein-low, D2i0 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) D2i0: No oleocanthal and no oleacein	Ibuprofen Ibuprofen, 400 mg Ibuprofen: 400 mg of Ibuprofen
Optical Platelet Aggregometry D2i2	-13 percentage of maximal aggregation Standard Deviation 36	—	—	—
Optical Platelet Aggregometry D2i0.5	-35 percentage of maximal aggregation Standard Deviation 39	—	—	—
Optical Platelet Aggregometry D2i0	7 percentage of maximal aggregation Standard Deviation 24	—	—	—
Optical Platelet Aggregometry Ibuprofen	-57.5 percentage of maximal aggregation Standard Deviation 32.9	—	—	—

SECONDARY outcome

Timeframe: Change from baseline 2 hours post intake

Population: healthy adult males

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.

Outcome measures

Measure	All Participants n=9 Participants All participants received all four study interventions. The first three interventions were administered in random order: * Oleocanthal-rich, D2i2 * Oleacein-rich, D2i0.5 * Oleocanthal and Oleacein-low, D2i0 All participants received the last intervention, 400 mg of Ibuprofen, at the fourth (final) study visit.	Oleacein-rich, D2i0.5 n=9 Participants Oleacein-rich, D2i0.5 (Extra virgin olive oil containing oleocanthal to oleacein in a 1:2 ratio) D2i0.5: Oleocanthal provided in a 1:2 ratio compared to oleacein	Oleocanthal and Oleacein-low, D2i0 n=9 Participants 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) D2i0: No oleocanthal and no oleacein	Ibuprofen n=9 Participants Ibuprofen, 400 mg Ibuprofen: 400 mg of Ibuprofen
Activated Platelet Oxylipin Production	-0.02 percentage of change from baseline	-0.45 percentage of change from baseline	-0.17 percentage of change from baseline	-0.66 percentage of change from baseline

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Roberta R Holt

University of California, Davis

Phone: 530-752-4950

Email: rrholt@ucdavis.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place