Acute Assessment of Platelet Reactivity After the Intake of Oleocanthal

NCT03528603 | Completed

• 1 other identifier: 1158686
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Platelet Aggregation; Nutritional and Metabolic Disease; Cardiovascular Diseases

Keywords

platelet, aggregation, phenolic, olive oil, oleocanthal

Outcome Measures

Primary Outcomes (1)

• Influence of Oleocanthal-rich EVOO intake on Collagen-induced platelet aggregometry

  Optical platelet aggregometry will be used to measure platelet aggregation. The percent maximal platelet aggregation will be measured. A reduction in maximal aggregation 2, 4 or 6 hours post EVOO intake compared to baseline will represent a reduction in platelet aggregation.

  baseline, 2, 4 and 6 hours

Secondary Outcomes (4)

• Influence of Oleocanthal-rich EVOO intake on Adenosine Diphosphate-induced platelet aggregometry

  baseline, 2, 4 and 6 hours

• Influence of Oleocanthal-rich EVOO intake on Arachidonic Acid-induced platelet aggregometry

  baseline, 2, 4 and 6 hours

• Influence of Oleocanthal-rich EVOO intake on Platelet-derived oxylipins

  baseline, 2, 4 and 6 hours

• Influence of Oleocanthal-rich EVOO intake on Metabolomics

  baseline, 2, 4 and 6 hours

Study Arms (2)

Oleocanthal-Rich Extra Virgin Olive Oil

EXPERIMENTAL

Extra Virgin Olive Oil that is high in the phenolic oleocanthal, but contains similar amounts of total phenolics as the Oleocanthal-Low Extra Virgin Olive Oil

Other: Oleocanthal-Rich Extra Virgin Olive Oil; Other: Oleocanthal-low Extra Virgin Olive Oil

Oleocanthal-Low Extra Virgin Olive Oil

PLACEBO COMPARATOR

Extra Virgin Olive Oil that is low in the phenolic oleocanthal, but contains similar amounts of total phenolics as the Oleocanthal-Rich Extra Virgin Olive Oil

Other: Oleocanthal-Rich Extra Virgin Olive Oil; Other: Oleocanthal-low Extra Virgin Olive Oil

Interventions

Oleocanthal-Rich Extra Virgin Olive Oil OTHER

Extra Virgin Olive Oil that contains a high level of the phenolic oleocanthal

Oleocanthal-Low Extra Virgin Olive Oil; Oleocanthal-Rich Extra Virgin Olive Oil

Oleocanthal-low Extra Virgin Olive Oil OTHER

Extra Virgin Olive Oil that contains a low level of the phenolic oleocanthal

Oleocanthal-Low Extra Virgin Olive Oil; Oleocanthal-Rich Extra Virgin Olive Oil

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Trials 1 and 2: Male; Trial 3: Male and Female
• years old
• For females, a regular 25-30-day menstrual cycle
• Subject is willing and able to comply with the study protocols
• Subject is willing to drink 40 mL (approximately 2 tablespoons) of olive oil
• BMI 18.5 - 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
• ug/ml and 3 ug/ml collagen screening maximal platelet aggregatory response of \< 65%.
• Platelet number or mean platelet values that are outside of the normal reference range as indicated on a complete blood cell count report from the UCD Med Center
• Current diagnosis of anemia; or a screening hemoglobin and hematocrit that is less than the normal reference range.
• Self-reported daily use of drugs that are known to affect platelet function, such as aspirin, Excedrin, and NSAIDS
• Females using hormonal contraception
• Ibuprofen intolerance or allergy
• Those with a bleeding disorder
• Non-English speaking
• Allergy to olives or olive oil
• Vegetarian, Vegan, food faddists, individuals using non-traditional diets, or on a weight loss diet.
• A history of cardiovascular disease, stroke, cancer, renal, hepatic, or thyroid disease, GI tract disorders, previous GI surgery
• Currently taking prescription drugs or supplements

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

Department of Nutrition

Davis, California, 95616, United States

Location

Related Links

• Learn more or sign up for the study here!

MeSH Terms

Conditions

Metabolic Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Extra Virgin Olive Oils will be stored and provided to the study investigators in coded single serving bottles
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: controlled, randomized, double-blind, with 2 interventions

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: May 18, 2018
• Study Start: April 2, 2018
• Primary Completion: March 1, 2023
• Study Completion: May 31, 2024
• Last Updated: June 24, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)