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| Name | Class |
|---|---|
| USDA, Western Human Nutrition Research Center | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oleocanthal-rich, D2i2 | Experimental | Oleocanthal-rich, D2i2 (Extra virgin olive oil containing oleocanthal to oleacein in a 2:1 ratio) |
|
| Oleacein-rich, D2i0.5 | Experimental | Oleacein-rich, D2i0.5 (Extra virgin olive oil containing oleocanthal to oleacein in a 1:2 ratio) |
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| Oleocanthal and Oleacein-low, D2i0 | Placebo Comparator | 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) |
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| Ibuprofen | Active Comparator | Ibuprofen, 400 mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D2i2 | Other | Oleocanthal provided in a 2:1 ratio compared to oleacein |
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| Measure | Description | Time Frame |
|---|---|---|
| Optical Platelet Aggregometry | Maximal platelet aggregation in minutes will be measured using optical platelet aggregometry | Change from baseline 2 hours post intake |
| Measure | Description | Time Frame |
|---|---|---|
| Activated Platelet Oxylipin Production | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberta R Holt, PhD | University of California, Davis | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29904393 | Result | Agrawal K, Melliou E, Li X, Pedersen TL, Wang SC, Magiatis P, Newman JW, Holt RR. Oleocanthal-rich extra virgin olive oil demonstrates acute anti-platelet effects in healthy men in a randomized trial. J Funct Foods. 2017 Sep;36:84-93. doi: 10.1016/j.jff.2017.06.046. Epub 2017 Jul 3. |
| Label | URL |
|---|---|
| manuscript | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | All participants received all four study interventions. The first three interventions were administered in random order:
All participants received the last intervention, 400 mg of Ibuprofen, at the fourth (final) study visit. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants received all four study interventions. The first three interventions were administered in random order:
All participants received the last intervention, 400 mg of Ibuprofen, at the fourth (final) study visit. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Optical Platelet Aggregometry | Maximal platelet aggregation in minutes will be measured using optical platelet aggregometry | Posted | Mean | Standard Deviation | percentage of maximal aggregation | Change from baseline 2 hours post intake |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | All participants received all four study interventions. The first three interventions were administered in random order:
All participants received the last intervention, 400 mg of Ibuprofen, at the fourth (final) study visit. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roberta R Holt | University of California, Davis | 530-752-4950 | rrholt@ucdavis.edu |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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All participants received all four interventions in a randomized, cross-over design in which both participant and caregiver were masked to the assignment (with the exception of the fourth intervention, ibuprofen, which was always administered at the final study visit).
| D2i0.5 | Other | Oleocanthal provided in a 1:2 ratio compared to oleacein |
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| D2i0 | Other | No oleocanthal and no oleacein |
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| Ibuprofen | Drug | 400 mg of Ibuprofen |
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| Change from baseline 2 hours post intake |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Activated Platelet Oxylipin Production | 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. | healthy adult males | Posted | Number | percentage of change from baseline | Change from baseline 2 hours post intake |
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| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
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