Acute Effect of Oleocanthal Rich Extra-virgin Olive Oil on Postpranial Hyperglycemia and Platelet Activation of T2DM Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change from baseline of ADP-induced platelet aggregation at 240 min after meals consumption
研究概览
简要总结
This is a pilot acute dietary intervention study with a randomized cross-over design aiming to investigate whether acute supplementation of extra virgin olive oil (EVOO) rich in oleocanthal could attenuate postprandial hyperglycemia and activation of platelets in T2DM patients. For this reason, non-insulin dependent diabetic patients (10-15) will be randomly assigned to consume in five different days white bread (50 g CHO) with butter, butter with ibuprofen, refined olive oil and olive oil with oleocanthal (250 mg/Kg 500 mg/Kg). Blood samples will be collected pre- and post-intervention up to 4 hours in order to determine platelet aggregation, postprnadial glycemia, lipemia, inflammation and oxidative stress.
Taking into account the strong anti-inflammatory and anti-platelet properties of oleocanthal, this study will assess whether oleocanthal-rich olive oils could exert similar effects under real in vivo conditions in T2DM patients. It will also assess whether these effects are achieved through improvement of postprandial glycemia and lipemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients diagnosed with T2DM
- •stable weight the last two months
- •smokers or not
- •no restriction regarding the menopause
排除标准
- •insulin therapy
- •antiplatelet, anti-coagulant, anti-inflammatory and anti-depressant medication
- •chronic inflammatory disease
- •autoimmune diseases
- •uncontrolled thyroid disease.
- •supplement consumption the last two months
结局指标
主要结局
Change from baseline of ADP-induced platelet aggregation at 240 min after meals consumption
时间窗: 0 and 240 after the consumption of each type of meal
EC50 (microM) of ADP induced platelet aggregation will be assessed by light transmittance aggregometry
Change from baseline of PAF-induced platelet aggregation at 240 min after meals consumption
时间窗: 0 and 240 after the consumption of each type of meal
EC50 (microM) of PAF induced platelet aggregation will be assessed by light transmittance aggregometry
Change from baseline of TRAP-induced platelet aggregation at 90 min after meals consumption
时间窗: 0 and 90 after the consumption of each type of meal
EC50 (microM) of TRAP induced platelet aggregation will be assessed by light transmittance aggregometry
Incremental Area Under the Serum Concentration Versus Time Curve (AUC) of Glucose
时间窗: 0, 15, 30, 60, 90 120, 180, 240 min after the consumption of each meal
iAUC of postprandial glucose will be calculated by serum glucose levels (mg/dL) which will be assessed by commercially available kits
Incremental Area Under the Serum Concentration Versus Time Curve (AUC) of Triglycerides
时间窗: 0, 15, 30, 60, 90 120, 180, 240 min after the consumption of each meal
iAUC of postprandial triglycerides will be calculated by serum triglyceride levels (mg/dL) which will be assessed by commercially available kits
Change from baseline of ADP-induced platelet aggregation at 90 min after meals consumption
时间窗: 0 and 90 after the consumption of each type of meal
EC50 (microM) of ADP induced platelet aggregation will be assessed by light transmittance aggregometry
Change from baseline of TRAP-induced platelet aggregation at 240 min after meals consumption
时间窗: 0 and 240 after the consumption of each type of meal
EC50 (microM) of TRAP induced platelet aggregation will be assessed by light transmittance aggregometry
Change from baseline of PAF-induced platelet aggregation at 90 min after meals consumption
时间窗: 0 and 90 after the consumption of each type of meal
EC50 (microM) of PAF induced platelet aggregation will be assessed by light transmittance aggregometry
Incremental Area Under the Serum Concentration Versus Time Curve (AUC) of Insulin
时间窗: 0, 15, 30, 60, 90 120, 180, 240 min after the consumption of each meal
iAUC of postprandial insulin will be calculated by serum insulin levels (mIU/L) which will be assessed by commercially available kits
次要结局
- Incremental Area Under the Plasma Concentration Versus Time Curve (AUC) of Protein Carbonyls(0, 60, 120, 180, 240 min after the consumption of each meal)
- Incremental Area Under the Serum Concentration Versus Time Curve (AUC) of IL-6(0, 60, 120, 180, 240 min after the consumption of each meal)
研究者
Tzortzis Nomikos
Assistant Professor of Biochemistry
Harokopio University