Effects of Polyphenols and Omega-3 Fatty Acids on Cardiovascular Rik Factors (Focusing on Postprandial Lipids Metabolism) in Subjects With High Risk for Type 2 Diabetes and Cardiovascular Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- incremental AUC after a test meal of triglycerides concentration in chylomicrons and VLDL fraction
研究概览
简要总结
The aim of this study is to explore if a 8-weeks dietary intervention with polyphenols and omega 3 fatty acids (alone or combined) may be effective on postprandial lipids metabolism and other cardiovascular risk factors in people at high cardiovascular risk.
详细描述
Fish consumption is associated with a lower cardiovascular risk and dietary supplementation with ω-3 fatty acids reduces plasma triglyceride levels. The mechanisms of action of ω-3 fatty acids are currently not completely understood. It has been hypothesized that polyunsaturated ω-3 fatty acids beneficial effects may be mediated through their ability to facilitate plasmalogen replenishment.
Polyphenols are associated with beneficial effects on some cardiovascular risk factors, in particular with a reduced lipid oxidation. Less data are available on their effects on lipid metabolism. Recent data suggest that these effects could be mediated by changes in plasmalogen levels.
The effects on lipid metabolism of combining the two dietary approaches (ω-3 fatty acids and polyphenols) are not known.
While developed populations live for the most part in the postprandial state, much of the information on lipid metabolism refers to fasting condition.
Dietary Intervention Study Design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •bmi >25<35 kg/m2
- •High waist circumference (men >102 cm, women >88 cm) + one the following components of metabolic syndrome :
- •Fasting plasma triglycerides ≥150 mg/dl Fasting HDL-col <40 mg/dl (men) and <50 mg/dl (women) Fasting plasma glucose 100-125 mg/dl
排除标准
- •Fasting plasma triglycerides ≥400 mg/dl and cholesterol >270 mg/dl
- •Cardiovascular events (AMI and/or stroke) in the last 6 months
- •Diabetes mellitus
- •Regular intensive physical activity
- •Kidney (serum creatinine >1.7 mg/dl) and liver (transaminases >double)
- •Hypolipidemic or antinflammatory drugs
- •Anemia (Hb <12 g/dl) or any other chronic disease
结局指标
主要结局
incremental AUC after a test meal of triglycerides concentration in chylomicrons and VLDL fraction
时间窗: 48 months
次要结局
- insulin sensitivity(48 months)
- plasma and adipose tissue adipokines(48 months)
- endothelial function(48 months)
研究者
rivellese angela
Associate Professor
Federico II University