Effect of Whole Grain Rich Diet on Insulin Sensitivity in Individuals With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Insulin Sensitivity (Si)
研究概览
简要总结
A diet with the multiple beneficial characteristics of whole grains and, more in general, of "healthy cereals" favorably influences glucose and insulin metabolism in subjects with metabolic syndrome. Therefore, the aim of the study is to evaluate the long term effects of a diet containing "healthy cereals" versus a control diet, on glucose and insulin metabolism in subjects with metabolic syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with at least three of the following criteria of metabolic syndrome according to ATPIII-NCEP criteria:
- •waist circumference >102 for men and 88 for women,
- •fasting total serum triacyglycerol concentration >1.7 mmol/L,
- •fasting HDL cholesterol <1.0 mmol/L for men or <1.3 mmol/L for women,
- •IFG (plasma glucose between 6.1 and 6.9 mmol/L) or
- •blood pressure >130/85 mmHg or use of blood pressure medication
- •Hypertension in stable control (BP <135/80 mmHg) by means of drugs, which will not be allowed to be changed during the study
- •Absence of main cardiovascular events (IMA, Ictus)
排除标准
- •Diabetes mellitus diagnosed according to history of diabetes or blood glucose ≥ 200 mg/dL (11.1 mmol/L) 2 hours after a 75 g Oral glucose tolerance test (OGTT) to be performed during the run-in period in all the subjects
- •Any drug able to influence glucose and lipid metabolism (hypolipidemic drugs, cholesterol lowering foodstuffs, anti-inflammatory drugs)
- •Renal failure (serum creatinine > 1.5 mg/dL) and liver failure (ALT/AST> 2 times above normal values)
- •Anemia (Hb < 12g/dl) or any other chronic disease
结局指标
主要结局
Insulin Sensitivity (Si)
时间窗: 12 weeks
Peripheral insulin sensitivity was assessed by FSIGT. A glucose dose of 300 mg/kg body weight was given intravenously followed by a bolus of 0.03 U/kg of insulin injected after 20 min. Blood samples were frequently collected for 3 h for the measurement of plasma glucose and serum insulin concentrations, utilized to calculate the insulin sensitivity index Si
次要结局
- Postprandial Insulin Changes(12 weeks)
- Postprandial Plasma Lipid Changes(12 weeks)
研究者
rivellese angela
prof
Federico II University