Davis, California 95616

  • Cardiovascular Diseases

Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT03528603


Primary Contact:

Roberta R Holt, PhD
Phone: 530-752-4950
Email: rrholt@ucdavis.edu


Backup Contact:

N/A


Location Contact:

Davis, California 95616
United States

Roberta R Holt, PhD
Phone: 530-752-4950
Email: rrholt@ucdavis.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 27, 2021

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