Acute Assessment of Platelet Reactivity After the Intake of Oleocanthal

Cardiovascular Diseases Clinical Trial

Official title:

Acute Assessment of Platelet Reactivity After the Intake of Oleocanthal From Extra Virgin Olive Oil in the Fasted and Fed Condition

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03528603
• Other study ID #: 1158686
• Status: Recruiting
• Phase: N/A
• Start date: April 2, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: University of California, Davis
• Contact: Roberta R Holt, PhD
• Phone: 530-752-4950
• Email: rrholt[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Trials 1 and 2: Male; Trial 3: Male and Female

• 20-45 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

Exclusion Criteria:

• Adults who are not able to consent

• BMI = 31 kg/m2

• Under current medical supervision

• 1 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

• 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 for six weeks prior to study enrollment.

• Not willing to refrain from olive oil consumption for 4 weeks prior to study enrollment, and throughout study enrollment

• Self-reported malabsorption (e.g. difficulty digesting or absorbing nutrients from food, potentially leading to bloating, cramping or gas)

• Current enrollee in a clinical research study.

• Individuals with blood clotting or platelet defect disorders

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Metabolic Diseases
• Nutritional and Metabolic Disease
• Platelet Aggregation

Intervention

Other:
• Oleocanthal-Rich Extra Virgin Olive Oil
Extra Virgin Olive Oil that contains a high level of the phenolic oleocanthal
• Oleocanthal-low Extra Virgin Olive Oil
Extra Virgin Olive Oil that contains a low level of the phenolic oleocanthal

Locations

Country	Name	City	State
United States	Department of Nutrition	Davis	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Influence of Oleocanthal-rich EVOO intake on Adenosine Diphosphate-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	Influence of Oleocanthal-rich EVOO intake on Arachidonic Acid-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	Influence of Oleocanthal-rich EVOO intake on Platelet-derived oxylipins	Oxylipin profile will be conducted from the activated platelet supernatant ultra high-performance liquid chromatography-mass spectrometry (HPLC) is used to measure levels of oxylipin. HPLC area under the peak will be measured.	baseline, 2, 4 and 6 hours
Secondary	Influence of Oleocanthal-rich EVOO intake on Metabolomics	Untargeted metabolomics will be performed to assess the relationship between platelet response and the presence of circulating plasma metabolites.	baseline, 2, 4 and 6 hours

External Links

•   Learn more or sign up for the study here!