Acute Assessment of Platelet Reactivity After the Intake of Oleocanthal
- Conditions
- Platelet AggregationCardiovascular DiseasesNutritional and Metabolic Disease
- Interventions
- Other: Oleocanthal-Rich Extra Virgin Olive OilOther: Oleocanthal-low Extra Virgin Olive Oil
- Registration Number
- NCT03528603
- Lead Sponsor
- University of California, Davis
- 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 26
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Oleocanthal-Rich Extra Virgin Olive Oil Oleocanthal-Rich Extra Virgin Olive Oil 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 Oleocanthal-Low Extra Virgin Olive Oil Oleocanthal-low Extra Virgin Olive Oil 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 Oleocanthal-Low Extra Virgin Olive Oil Oleocanthal-Rich Extra Virgin Olive Oil 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 Oleocanthal-Rich Extra Virgin Olive Oil Oleocanthal-low Extra Virgin Olive Oil 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
- Primary Outcome Measures
Name Time Method Influence of Oleocanthal-rich EVOO intake on Collagen-induced platelet aggregometry baseline, 2, 4 and 6 hours 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.
- Secondary Outcome Measures
Name Time Method Influence of Oleocanthal-rich EVOO intake on Arachidonic Acid-induced platelet aggregometry baseline, 2, 4 and 6 hours 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.
Influence of Oleocanthal-rich EVOO intake on Platelet-derived oxylipins baseline, 2, 4 and 6 hours 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.
Influence of Oleocanthal-rich EVOO intake on Metabolomics baseline, 2, 4 and 6 hours Untargeted metabolomics will be performed to assess the relationship between platelet response and the presence of circulating plasma metabolites.
Influence of Oleocanthal-rich EVOO intake on Adenosine Diphosphate-induced platelet aggregometry baseline, 2, 4 and 6 hours 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.
Trial Locations
- Locations (1)
Department of Nutrition
🇺🇸Davis, California, United States