Clinical trial NCT03528603: Acute Assessment of Platelet Reactivity After the Intake of Oleocanthal
Official title: Acute Assessment of Platelet Reactivity After the Intake of Oleocanthal From Extra Virgin Olive Oil in the Fasted and Fed Condition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Platelet Aggregation
Nutritional and Metabolic Disease
Cardiovascular Diseases
Keywords: platelet, aggregation, phenolic, olive oil, oleocanthal
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2018-05-18
Enrollment: 26
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: controlled, randomized, double-blind, with 2 interventions
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Influence of Oleocanthal-rich EVOO intake on Collagen-induced platelet aggregometry
timeFrame: baseline, 2, 4 and 6 hours
Secondary outcomes:
measure: Influence of Oleocanthal-rich EVOO intake on Adenosine Diphosphate-induced platelet aggregometry
timeFrame: baseline, 2, 4 and 6 hours
measure: Influence of Oleocanthal-rich EVOO intake on Arachidonic Acid-induced platelet aggregometry
timeFrame: baseline, 2, 4 and 6 hours
measure: Influence of Oleocanthal-rich EVOO intake on Platelet-derived oxylipins
timeFrame: baseline, 2, 4 and 6 hours
measure: Influence of Oleocanthal-rich EVOO intake on Metabolomics
timeFrame: baseline, 2, 4 and 6 hours
Other outcomes:
Locations:
city: Davis
country: United States
facility: Department of Nutrition
state: California
Study officials:
References: