Effects of Tocotrienols Supplementation on Platelet Aggregation in Subjects With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Platelet Aggregation
研究概览
简要总结
The objective of this study is to address the anti-thrombotic effects of tocotrienols supplementation via modulation of platelet activation, thrombotic markers, inflammatory markers and endothelial function.
It is hypothesized that 2 weeks supplementation of tocotrienols will be able to suppress platelet aggregation in subjects with metabolic syndrome.
详细描述
A double-blind, randomized, crossover study comparing the effects of tocotrienols vs. placebo will be conducted in subjects with metabolic syndrome. Subjects will be supplemented with Tocovid Suprabio 200 mg twice daily (or placebo) for 2 weeks followed by a postprandial challenge on Day 14. During the postprandial challenge, venous blood samples will be collected during fasting. Subjects are then required to consume a high fat breakfast meal containing 50g fat and 100mL milkshake, followed by the assigned capsules. Venous blood samples will be drawn at 2, 4 and 6 hours after consumption of capsules. A washout period of at least 14 days will be in place before the commencement of the second treatment.
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)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 25-60 year
- •Haemoglobin level >11.5 g/dL in women and >12.5 g/dL in men
- •Serum ferritin > 15µg/L
- •According to Clinical Practice Guidelines, Management of Type 2 Diabetes Mellitus in Malaysia (2009), metabolic syndrome subjects are identified with:
- •Waist circumference ≥ 90 cm in men and ≥ 80 cm in women
- •and with any two of the following criteria:
- •Elevated triacylglycerols > 1.7 mmol/L
- •Low HDL cholesterol < 1.0 mmol/L in men and < 1.3 mmol/L in women
- •Elevated blood pressure ≥ 130/≥85 mm Hg
- •Fasting glucose ≥ 5.6 mmol/L to 7 mmol/L
排除标准
- •Medical history of myocardial infarction, angina, ischemic attack, hemorrhagic stroke, deep vein thrombosis, coronary artery disease, bleeding disorder, cancer, allergy to vitamin E
- •Lactose intolerance
- •Pregnancy or lactation
- •Current use of vitamin E, medications modulating blood coagulation, hypertension, lipid-lowering and glucose-lowering agents, corticosteroids
- •Significant hepatic and renal impairment
- •Fever, cold or infection during bleeding day
- •Alcoholic
研究组 & 干预措施
Tocotrienol-rich fraction 400mg
干预措施: Tocotrienol-rich fraction 400mg (Dietary Supplement)
Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Platelet Aggregation
时间窗: Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr
Comparison will be made between Day 14-fasting and changes will be measured between Day 14-fasting and 4hr.
次要结局
- Full blood count and liver function test(Day 0-fasting and Day 14-fasting)
- Haemostatic markers (Plasminogen activator inhibitor type 1 and sP-selectin)(Day 0 - fasting, Day 14 - fasting, Day 14 - 2hr, Day 14 - 4hr, Day 14 - 6 hr)
- Inflammatory markers (sE-selectin, sICAM-1, and sVCAM-1)(Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr)
- Lipid Profile(Day 0 - fasting, Day 14 - fasting)
- D-dimer(Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr)
- Platelet activation(Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr)