Impact of Extra Virgin Olive Oil Oleocanthal Content on Platelet Reactivity

NCT02902913 | Completed Results

• 1 other identifier: 617247
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cardiovascular Diseases

Keywords

platelet reactivity; phenolic; extra virgin olive oil; cyclooxygenase; oleocanthal; oxylipin

Outcome Measures

Primary Outcomes (1)

• Optical Platelet Aggregometry

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

  Change from baseline 2 hours post intake

Secondary Outcomes (1)

• Activated Platelet Oxylipin Production

  Change from baseline 2 hours post intake

Study Arms (4)

Oleocanthal-rich, D2i2

EXPERIMENTAL

Oleocanthal-rich, D2i2 (Extra virgin olive oil containing oleocanthal to oleacein in a 2:1 ratio)

Other: D2i2

Oleacein-rich, D2i0.5

EXPERIMENTAL

Oleacein-rich, D2i0.5 (Extra virgin olive oil containing oleocanthal to oleacein in a 1:2 ratio)

Other: D2i0.5

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)

Other: D2i0

Ibuprofen

ACTIVE COMPARATOR

Ibuprofen, 400 mg

Drug: Ibuprofen

Interventions

D2i2 OTHER

Oleocanthal provided in a 2:1 ratio compared to oleacein

Also known as: Oleocanthal-rich

Oleocanthal-rich, D2i2

D2i0.5 OTHER

Oleocanthal provided in a 1:2 ratio compared to oleacein

Also known as: Oleocanthal-low

Oleacein-rich, D2i0.5

D2i0 OTHER

No oleocanthal and no oleacein

Also known as: Control EVOO

Oleocanthal and Oleacein-low, D2i0

Ibuprofen DRUG

400 mg of Ibuprofen

Ibuprofen

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willing and able to comply with study protocols
• Willing to drink 2 tablespoons of olive oil
• BMI 18.5 to 30 kg/m2
• Weight ≥ 110 pounds

You may not qualify if:

• Adults who are not able to consent
• BMI ≥ 31 kg/m2
• Under current medical supervision
• Self-reported daily use of drugs that are known to affect platelet function, such as aspirin, Excedrin, and NSAIDS
• Ibuprofen intolerance or allergy
• Cannot speak English
• Allergy to olives or olive oil
• Vegetarian, Vegan, food faddists, individuals using non-traditional diets, on a weight loss diet or individual following diets with significant deviations from the average diet of the general population.
• A history of cardiovascular disease, stroke, cancer, renal, hepatic, or thyroid disease, GI tract disorders, previous GI surgery
• Currently taking prescription drugs or supplements
• Indications of substance or alcohol abuse within the last 3 years
• Not willing to stop any supplement use, including herbal, plant or botanical, fish oil, oil supplements.
• Not willing to refrain from olive oil consumption.
• Blood Pressure ≥ 140/90 mmHg
• Self-reported malabsorption

Sponsors & Collaborators

• University of California, Davis: lead
• USDA, Western Human Nutrition Research Center: collaborator

Related Publications (1)

• 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.

  PMID: 29904393 RESULT

Related Links

• manuscript

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Roberta R Holt
• Organization: University of California, Davis

rrholt@ucdavis.edu

530-752-4950

Study Officials

• Roberta R Holt, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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).
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: September 16, 2016
• Study Start: January 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 27, 2021
• Results First Posted: November 7, 2019

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share