Acute Assessment of Platelet Reactivity After the Intake of Oleocanthal From Extra Virgin Olive Oil in the Fasted and Fed Condition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Influence of Oleocanthal-rich EVOO intake on Collagen-induced platelet aggregometry
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Extra Virgin Olive Oils will be stored and provided to the study investigators in coded single serving bottles
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Influence of Oleocanthal-rich EVOO intake on Collagen-induced platelet aggregometry
时间窗: 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.
次要结局
- Influence of Oleocanthal-rich EVOO intake on Arachidonic Acid-induced platelet aggregometry(baseline, 2, 4 and 6 hours)
- Influence of Oleocanthal-rich EVOO intake on Platelet-derived oxylipins(baseline, 2, 4 and 6 hours)
- Influence of Oleocanthal-rich EVOO intake on Metabolomics(baseline, 2, 4 and 6 hours)
- Influence of Oleocanthal-rich EVOO intake on Adenosine Diphosphate-induced platelet aggregometry(baseline, 2, 4 and 6 hours)