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临床试验/NCT00523861
NCT00523861已完成不适用

The Effect of Moderate Alcohol Consumption on Glucose Metabolism and Gastric Emptying in Healthy, Lean and Overweight Young Men

TNO2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2005年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
17
试验地点
2
主要终点
The primary objective of this study is to investigate the effect of moderate daily alcohol consumption on hepatic glucose uptake and peripheral glucose storage

研究概览

简要总结

Moderate alcohol consumption is associated with a decreased risk of type II diabetes mellitus. In a recent study of Greenfield et al. it was observed that moderate alcohol consumption significantly improved postprandial glucose concentrations. Similar observations were made in our previous study. One of the mechanisms by which this may occur is delayed gastric emptying after alcohol consumption.

详细描述

Purpose: The primary objective of this study is to investigate the effect of moderate daily alcohol consumption on hepatic glucose uptake and peripheral glucose storage. Secondly, the effect of moderate alcohol consumption on gastric emptying and postprandial wellness will be studied. These effects will be studied in apparently healthy, lean or overweight young men.

Design: Randomized, partially diet-controlled, placebo controlled cross-over design.

Subjects: Healthy male lean and obese volunteers aged between 18 and 40 years (n=18).

Intervention: During 2 periods of 21 days either white wine or white grape juice has to be consumed with the evening meal. The last 7 days of each period will be fully dietary controlled.

Treatment A: 375 ml of white wine (35 g alcohol) per day Treatment B: 375 ml of white grape juice per day

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy as assessed by the:
  • physical examination
  • results of the pre-study laboratory tests
  • Males aged between 18 and 40 years at Day 01 of the study (including 18 and 40)
  • Lean subjects and overweight/obese subjects: BMI 18.5-35 kg/m2
  • Alcohol consumption between 7 and 28 units/week (including 7 and 28)
  • Non restrained eater, defined as a score ≤ 2.5 on the Dutch Restrained Eating Questionnaire

排除标准

  • Not willing or able to change habitual alcohol consumption during the study according to protocol
  • Having an allergy for paracetamol

结局指标

主要结局

The primary objective of this study is to investigate the effect of moderate daily alcohol consumption on hepatic glucose uptake and peripheral glucose storage

时间窗: 3 weeks

次要结局

  • Secondly, the effect of moderate alcohol consumption on gastric emptying and postprandial wellness will be studied.(3 weeks)

研究者

发起方
TNO
申办方类型
Other

研究点 (2)

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