Acute Effects of Tocotrienols on Insulinaemic and Inflammatory Responses in Metabolic Syndrome Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- C-peptide
研究概览
简要总结
Objectives: To compare the acute effects of gamma delta rich tocotrienol fractions (gd-TRF) on insulin sensitivity, metabolic risk markers and postprandial lipemia in individuals at risk for metabolic syndrome.
Hypothesis: Gamma delta-rich TRF will improve insulin sensitivity, metabolic risk markers and postprandial lipemia in individuals at risk for metabolic syndrome.
详细描述
A randomised, double-blind, crossover trial will be undertaken to test the acute effects of supplementation of 200 mg, 400 mg gd-TRF vs. placebo. There are 3 occasions for subjects to attend during postprandial period and these occasions will be separated by at least one week. On the day preceding the postprandial high fat meal challenge, subjects will be asked to avoid food high in fat, alcohol, caffeine and taking part in any strenuous exercise. Subjects will be provided with a standardised low fat meal (containing < 10 g fat) on the day preceding the postprandial study days to consume as their evening meal. They will be asked to fast overnight and instructed to avoid eating or drinking anything, except water, after 10 pm. Fasting blood samples will be collected on the next day and subjects will then consume the test meal, containing 50 g test fat supplemented with gd-TRF. Further venous blood samples will be collected at regular intervals for up to 6 hours postprandially.
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 20-60 years
- •BMI ≥ 25 kg/m2
- •Elevated triacylglycerols ≥ 1.70 mmol/L
- •Low HDL cholesterol < 1.04 mmol/L (men), < 1.30 mmol/L (women)
- •Elevated blood pressure ≥ 130/ ≥ 85 mmHg
- •Fasting plasma glucose ≥ 5.60 - 7.00 mmol/L
- •Increased waist circumference ≥ 90 cm (men), ≥ 80 cm (women)
排除标准
- •BMI ≤ 18.5 kg/m2
- •Current use of antihypertensive or lipid lowering, insulin/glucose modulating medication
- •Lactose/milk intolerance
- •Alcohol intake exceeding a moderate intake (> 28 units per week)
- •Pregnancy or lactation
- •Fever, cold and infection during bleeding day
结局指标
主要结局
C-peptide
时间窗: 0, 15, 30, 60, 90, 120, 180, 240, 300, 360 min
次要结局
- Insulin sensitivity (insulin, glucose)(0, 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 min)
- Non-esterified fatty acid (NEFA)(0, 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 min)
- Serum triglycerides (TAG)(0, 60, 120, 180, 240, 300, 360 min)
- Inflammatory markers (IL-6, IL-1β, TNF-α)(0, 120, 240, 360 min)
- PBMC nuclear factor-κappa B (NF-κB)(0, 240, 360 min)