The Influence of Water and Salt Intake on Copeptin Levels During Moderate Alcohol Consumption - a Pathophysiological Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Difference in copeptin levels between the interventions
研究概览
简要总结
The main interest of this study is to investigate the influence of moderate alcohol consumption (beer) on salt-water homeostasis. Therefore, 10 healthy volunteers will participate in 4 Intervention:
- Beer alone
- Beer and water
- Beer and salt (stock/bouillon)
- Water alone During the study day, copeptin, sodium, osmolality and urinary sodium/osmolality will be measured at 6 timepoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males
排除标准
- •Any acute or chronic illness
- •History of alcohol dependency
- •Alcohol consumption >2 units/day
- •Active nicotine abuse
- •Gluten intolerance
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, etc. of the participant
- •Participation in another study with investigational drug within the 30 days preceding and during the present study
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
- •Epileptic seizures within the last year
- •BMI <18.5 or ≥25.9kg/m2
研究组 & 干预措施
Beer alone
Consumption of beer (correlated for weight to reach a blood alcohol concentration of 0.8) during 1 hour. Continues measurement of sodium, osmolality, copeptin, urinary sodium, urinary osmolality over 12 hours.
干预措施: Beer 5%o (Other)
Beer and water
Consumption of beer and additional water (correlated for weight to reach a blood alcohol concentration of 0.8, 1/3 of water, 2/3 of beer) during 1 hour. Continues measurement of sodium, osmolality, copeptin, urinary sodium, urinary osmolality over 12 hours.
干预措施: Beer 8.5%o and water (Other)
Beer and stock
Consumption of beer and additional stock(correlated for weight to reach a blood alcohol concentration of 0.8, 1/3 of stock, 2/3 of beer) during 1 hour. Continues measurement of sodium, osmolality, copeptin, urinary sodium, urinary osmolality over 12 hours.
干预措施: Beer 8.5%o and stock (Other)
Water alone
Consumption of water alone (correlated for weight to reach a blood alcohol concentration of 0.8, 1/3 of stock, 2/3 of beer) during 1 hour. Continues measurement of sodium, osmolality, copeptin, urinary sodium, urinary osmolality over 12 hours.
干预措施: Water (Other)
结局指标
主要结局
Difference in copeptin levels between the interventions
时间窗: 30 minutes after intervention
Difference in copeptin levels (pmol/l) between moderate beer consumption and moderate beer consumption with additional water and sodium (stock/bouillon) intake at timepoint 1.5 hours.
次要结局
- Change in copeptin levels between the interventions throughout the observation period of 12 hours(Observation period of 12 hours)
- Change in biomarkers involved in the sodium-water homeostasis between the interventions throughout the observation period of 12 hours(Observation period of 12 hours)
- Change in plasma sodium levels between the interventions throughout the observation period of 12 hours(Observation period of 12 hours)
- Change in urinary sodium levels between the interventions throughout the observation period of 12 hours(Observation period of 12 hours)
- Change in blood alcohol content between the interventions throughout the observation period of 12 hours(Observation period of 12 hours)
- Change in plasma osmolality levels between the interventions throughout the observation period of 12 hours(Observation period of 12 hours)
- Change in urinary osmolality levels between the interventions throughout the observation period of 12 hours(Observation period of 12 hours)
- Change in plasma Glucose levels between the interventions throughout the observation period of 12 hours(Observation period of 12 hours)
- Difference in Response to lottery Experiment before and after the intervention(Directly before and 30 minutes after intervention)
- Difference in urinary excretion between the interventions throughout the observation period of 12 hours(Observation period of 12 hours)