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临床试验/NCT02865278
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

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

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

rivellese angela

Full professor

Federico II University

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