Moderate Alcohol Consumption, Glucose Metabolism and Gastric Emptying
The Effect of Moderate Alcohol Consumption on Glucose Metabolism and Gastric Emptying in Healthy, Lean and Overweight Young Men
研究概览
详细说明
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
Measures:
- Glucose metabolism: glucose uptake and peripheral glucose storage (measurement of isotopic enriched plasma glucose levels.
- Gastric emptying and postprandial wellness.
- Postprandial glycemic response and related factors (glucose, insulin, lactate, FFA, glucagon, ghrelin, CCK, GIP, GLP-1, PYY, triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, paracetamol (absorption test)
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Utrecht
-
Zeist、Utrecht、荷兰、3700AJ
- TNO Quality of Life
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Smoking
- Not willing or able to change habitual alcohol consumption during the study according to protocol
- Having an allergy for paracetamol
学习计划
研究是如何设计的?
设计细节
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
The primary objective of this study is to investigate the effect of moderate daily alcohol consumption on hepatic glucose uptake and peripheral glucose storage
大体时间:3 weeks
|
3 weeks
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Secondly, the effect of moderate alcohol consumption on gastric emptying and postprandial wellness will be studied.
大体时间:3 weeks
|
3 weeks
|
合作者和调查者
赞助
调查人员
- 首席研究员:Henk FJ Hendriks, PhD、Hendriks HFJ
研究记录日期
研究主要日期
学习开始
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.