Acute Assessment of Platelet Reactivity After the Intake of Oleocanthal

Completed · Not applicable

Conditions studied: Platelet Aggregation, Nutritional and Metabolic Disease, Cardiovascular Diseases

In brief

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.

Key facts

Study ID

NCT03528603

Run by

University of California, Davis

People needed

26

Starts

2018-04-02

Expected to finish

2024-05-31

Last updated by the study team

2024-06-24

Who can join

Age: 20 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Department of Nutrition — Davis, California, United States

Full record on ClinicalTrials.gov

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