Alcohol Drinking
Conditions
Keywords
Copeptin, Salt-water homeostasis
Brief summary
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.
Interventions
OTHERBeer 5%o
Weight adjusted beer to reach 0.8 blood alcohol content will be given over the time course of 1 hour to the participants
OTHERBeer 8.5%o and water
Weight adjusted beer to reach 0.8 blood alcohol content and water will be given over the time course of 1 hour to the participants
OTHERBeer 8.5%o and stock
Weight adjusted beer to reach 0.8 blood alcohol content and stock will be given over the time course of 1 hour to the participants
OTHERWater
Water equivalent to the calculated volume of beer will be given over the time course of 1 hour to the participants
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in copeptin levels between the interventions | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in plasma sodium levels between the interventions throughout the observation period of 12 hours | Observation period of 12 hours | Change in plasma sodium (mmol/l) from baseline to time-point 1 hour, 1.5 hours, 2.5 hours, 4 hours, 12 hours after start of the intervention, comparing the interventions |
| Change in urinary sodium levels between the interventions throughout the observation period of 12 hours | Observation period of 12 hours | Change in urinary sodium (mmol/kg) from baseline to time-point 1 hour, 1.5 hours, 2.5 hours, 4 hours, 12 hours after start of the intervention, comparing the interventions |
| Change in plasma osmolality levels between the interventions throughout the observation period of 12 hours | Observation period of 12 hours | Change in plasma osmolality (mmol/kg) levels from baseline to time-point 1 hour, 1.5 hours, 2.5 hours, 4 hours, 12 hours after start of the intervention, comparing the interventions |
| Change in urinary osmolality levels between the interventions throughout the observation period of 12 hours | Observation period of 12 hours | Change in urinary osmolality (mmol/kg) levels from baseline to time-point 1 hour, 1.5 hours, 2.5 hours, 4 hours, 12 hours after start of the intervention, comparing the interventions |
| Change in copeptin levels between the interventions throughout the observation period of 12 hours | Observation period of 12 hours | Change in copeptin Levels (pmol/l) from baseline to time-point 1 hour, 1.5 hours, 2.5 hours, 4 hours, 12 hours after start of the Intervention, comparing the interventions |
| 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 different biomarkers (e.g., Fibroblast growth factor 21, aldosterone, renin, Interleukin 6, Interleukin 8) from baseline to time-point 1 hour, 1.5 hours, 2.5 hours, 4 hours, 12 hours after start of the intervention, comparing the interventions |
| Difference in urinary excretion between the interventions throughout the observation period of 12 hours | Observation period of 12 hours | Amount of total urinary excretion (ml) at time-point 1 hour, 1.5 hours, 2.5 hours, 4 hours and 12 hours after start of the intervention, comparing the interventions |
| Change in blood alcohol content between the interventions throughout the observation period of 12 hours | Observation period of 12 hours | Change in blood alcohol content (°/oo) from baseline to time-point 1 hour, 1.5 hours, 2.5 hours, 4 hours and 12 hours after start of the intervention, comparing the interventions |
| Difference in Response to lottery Experiment before and after the intervention | Directly before and 30 minutes after intervention | Change in decision making before and after the intervention, comparing the interventions |
| Change in plasma Glucose levels between the interventions throughout the observation period of 12 hours | Observation period of 12 hours | Change in plasma glucose (mmol/l) levels from baseline to time-point 1 hour, 1.5 hours, 2.5 hours, 4 hours, 12 hours after start of the intervention, comparing the interventions |
Countries
Switzerland
Outcome results
None listed