Acute Assessment of Platelet Reactivity After the Intake of Oleocanthal
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
26 participants in 2 patient groups, including a placebo group
Trial contacts and locations
Loading...
Central trial contact
Roberta R Holt, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal