Impact of Extra Virgin Olive Oil Oleocanthal Content on Platelet Reactivity in Healthy Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 主要终点
- Optical Platelet Aggregometry
研究概览
简要总结
Data from limited dietary intervention trials suggest that the cardiovascular health benefit of extra virgin olive oil (EVOO) may increase with phenolic content. However, while EVOOs contain an array of bioactive compounds, little information exists regarding the physiological effects of specific chemical species. Among the EVOO-derived phenolics with demonstrated anti-inflammatory effects in animal and in vitro models is oleocanthal, an inhibitor of cyclooxygenase (COX). The current study compared the impact of acute intake (40 mL) of EVOO on platelet reactivity in healthy adult males (n=9). The volunteers were randomly assigned to consume three EVOOs in a double-blind controlled trial. The EVOO were characterized and chosen for equivalency in their total phenolic content and fatty acid profiles, but differing in their oleocanthal to oleacein ratio.
详细描述
Ten healthy adult males (20-50 years of age) will be enrolled into a randomized triple-blind, controlled crossover study that will test the acute effects of oleocanthal-rich extra virgin olive oil intake on platelet aggregation. Each participant will be asked to participate in four study days, separated by at least 1-week, in which they will be randomized to consume on each study day 40 mL (~3 tablespoons) of either oleocanthal-rich extra virgin olive oil (OO), or an extra virgin OO that is matched in total phenolics but oleocanthal-poor, or a refined OO that is low in all phenolics In addition to the oils, on a fourth study day visit, after completion of the study visits involving oil intake the subjects will be asked to take 400mg of ibuprofen.
Collection procedures will be performed at the same time of the day to avoid circadian effects. A blood sample (50 mL ~ 3.5 tbsp) will be collected for the measurement of platelet aggregometry and COX metabolites. Following this initial blood draw, the subjects will consume their assigned test product for the day. Two-hours following the intake of the assigned olive oil, a second blood sample will be drawn (50 mL ~ 3.5 tbsp). After the second blood draw, the study day will be complete.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
All participants received all four interventions in a randomized, cross-over design in which both participant and caregiver were masked to the assignment (with the exception of the fourth intervention, ibuprofen, which was always administered at the final study visit).
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Willing and able to comply with study protocols
- •Willing to drink 2 tablespoons of olive oil
- •BMI 18.5 to 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
- •Self-reported daily use of drugs that are known to affect platelet function, such as aspirin, Excedrin, and NSAIDS
- •Ibuprofen intolerance or allergy
- •Cannot speak English
- •Allergy to olives or olive oil
- •Vegetarian, Vegan, food faddists, individuals using non-traditional diets, on a weight loss diet or individual following diets with significant deviations from the average diet of the general population.
- •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.
- •Not willing to refrain from olive oil consumption.
- •Blood Pressure ≥ 140/90 mmHg
- •Self-reported malabsorption
- •Metabolic panel results or complete blood counts that are outside of the normal reference range.
- •Screening LDL ≥ 190 mg/dl for those who have 0 - 1 major risk factors apart from LDL cholesterol [(i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL].
- •Screening LDL ≥ 160 mg/dl for those who have 2 major risk factors apart from LDL cholesterol [(i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL].
- •Screening LDL ≥ than 130 mg/dl for those who have 2 major risk factors apart from LDL cholesterol ((i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL), and a Framingham 10 - year Risk Score 10 - 20 % (using NCEP calculator).
- •Current enrollee in a clinical research study.
- •Individuals with blood clotting or platelet defect disorders
研究组 & 干预措施
Oleocanthal-rich, D2i2
Oleocanthal-rich, D2i2 (Extra virgin olive oil containing oleocanthal to oleacein in a 2:1 ratio)
干预措施: D2i2 (Other)
Oleacein-rich, D2i0.5
Oleacein-rich, D2i0.5 (Extra virgin olive oil containing oleocanthal to oleacein in a 1:2 ratio)
干预措施: D2i0.5 (Other)
Oleocanthal and Oleacein-low, D2i0
Oleocanthal and Oleacein-low, D2i0 (Extra virgin olive oil containing low amounts of oleocanthal to oleacein, but with a similar total phenolic content as the other two oils)
干预措施: D2i0 (Other)
Ibuprofen
Ibuprofen, 400 mg
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Optical Platelet Aggregometry
时间窗: Change from baseline 2 hours post intake
Maximal platelet aggregation in minutes will be measured using optical platelet aggregometry
次要结局
- Activated Platelet Oxylipin Production(Change from baseline 2 hours post intake)