Effects of Aleurone-enriched Products on Fasting and Postprandial Glycemic Homeostasis and Lipid Metabolism in High Cardiovascular Risk Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- change in fasting and postprandial insulin levels
研究概览
简要总结
Very few studies have evaluated the effect of aleurone-enriched grains on cardiovascular risk factors. Price et al.(2010) have shown that 4-week supplementation of aleurone-enriched products (27 g/day of aleurone) increased betaine concentration in plasma whereas reduced homocysteine and LDL-cholesterol levels. Interestingly, aleurone had no effect on total antioxidant status or endothelial function, whereas an improvement of C-reactive protein was observed (Price RK et al, 2012). It is not known whether consumption of more than 27g/day of aleurone-enriched products with higher ferulic acid biodisponibility and longer time of treatment could influence these parameters in individuals with metabolic syndrome. Noteworthy, no studies have investigated the effect of aleurone-enriched products on fasting and postprandial glycemic homeostasis and lipid metabolism. In addition, mechanisms by which aleurone may act in vivo are still unknown.
The aim of this study is to investigate whether 8 weeks supplementation with aleurone-enriched products may influence glucose and lipid metabolism, incretin hormones levels, satiety, inflammation, oxidative stress and endothelial function in overweight/obese subjects with high cardiovascular risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Overweight/obese subjects of both gender
- •Age range between 20 and 70 years
- •High cardiovascular and metabolic risk profile will be enrolled in the study
- •Waist circumference > 102 cm for men, and > 88 cm for women
- •At least one of the characteristics of the metabolic syndrome according to the NCEP/ATP III criteria:
- •Fasting triglycerides ≥150 mg/dl
- •High-density lipoprotein cholesterol <40 mg/dl (men)/<50 mg/dl (women)
- •Blood pressure ≥ 130/85 mmHg
- •Fasting glucose ≥100 mg/dl
排除标准
- •Age <20 and >70 years
- •Fasting triglycerides ≥400 mg/dl
- •Fasting cholesterol >270 mg/dl
- •Cardiovascular events (myocardial infarction or stroke) during the 6 months prior to the study; established diabetes mellitus or any chronic disease
- •Renal and liver failure (creatinine >1.7 mg/dl and ALT/AST >2 times than normal values, respectively)
- •Anaemia (Hb <12 g /dl)
- •Any chronic disease
- •People treated with antihypertensive drugs will have to keep the type and dosage of medication unchanged during the whole study period
研究组 & 干预措施
Aleurone
Diet based in aleurone-enriched products for a period of 8 weeks.
干预措施: Aleurone (Other)
Control
Diet based on refined cereal products for a period of 8 weeks.
干预措施: Control (Other)
结局指标
主要结局
change in fasting and postprandial insulin levels
时间窗: 8 weeks after the dietary intervention
次要结局
未报告次要终点
研究者
rivellese angela
Gabriele Riccardi
Federico II University