NCT02865278Unknown不适用
Evaluation of the Bioavailability of Polyphenols From a Red Grape Extract-based Drink and the Acute Effects of Its Consumption on Glucose and Lipid Response During the Subsequent Meal
Federico II University0 个研究点目标入组 10 人开始时间: 2016年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 主要终点
- Phenolic metabolites in urine
研究概览
简要总结
Randomized placebo-controlled crossover study during which participants undergo two different experimental days. The participants consume a red grape based- drink (polyphenols: 300 mg/100 ml and sugar: 9.8g/100 ml) or a placebo (no polyphenols and sugar: 9.8g/100 ml). After 3 hours they consume a test meal (905 kcal, 15% protein, 46% fat, 39% CHO). Blood samples are taken at fasting, over 3 hours after drink consumption and over 5 hours after the test meal to evaluate metabolic response. Fasting and 48h-urine are collected to evaluate bioavailability.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI >25 and <35 kg/m2
- •Total cholesterol <250 mg/dl
- •Triglyceride < 200 mg/dl.
- •Fasting glucose <100 mg/dl
排除标准
- •Cardiovascular events (IMA or stroke) in the 6 months prior to the study
- •Kidney or liver failure
- •Anemia (Hb <12 g/dl)
- •Any chronic disease
- •Intense physical activity
- •Dietary supplements
结局指标
主要结局
Phenolic metabolites in urine
时间窗: 48 hours
GCxGC-MS
次要结局
- Triglyceride response(8 hours)
- Glucose response(8 hours)
- Inflammation(8 hours)
- Oxidative stress (urinary isoprostanes)(8 hours)
研究者
rivellese angela
Full professor
Federico II University
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