The Influence of Water and Salt Intake on Copeptin Levels During Moderate Alcohol Consumption

Study Overview
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Brief Summary
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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.

Official Title
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The Influence of Water and Salt Intake on Copeptin Levels During Moderate Alcohol Consumption - a Pathophysiological Study

Conditions
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Alcohol Drinking

Intervention / Treatment
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* Other: Beer 5%o
* Other: Beer 8.5%o and water
* Other: Beer 8.5%o and stock
* Other: Water


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beer alone<br>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. | Other: Beer 5%o<br>* Weight adjusted beer to reach 0.8 blood alcohol content will be given over the time course of 1 hour to the participants<br>|
| Active Comparator: Beer and water<br>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. | Other: Beer 8.5%o and water<br>* 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<br>|
| Active Comparator: Beer and stock<br>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. | Other: Beer 8.5%o and stock<br>* 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<br>|
| Placebo Comparator: Water alone<br>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. | Other: Water<br>* Water equivalent to the calculated volume of beer will be given over the time course of 1 hour to the participants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in copeptin levels between the interventions | 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. | 30 minutes after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in copeptin levels between the interventions throughout the 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 | Observation period of 12 hours | 
| Change in plasma sodium levels between the interventions throughout the 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 | Observation period of 12 hours | 
| Change in urinary sodium levels between the interventions throughout the 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 | Observation period of 12 hours | 
| Change in plasma osmolality levels between the interventions throughout the 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 | Observation period of 12 hours | 
| Change in urinary osmolality levels between the interventions throughout the 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 | Observation period of 12 hours | 
| Change in plasma Glucose levels between the interventions throughout the 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 | Observation period of 12 hours | 
| Change in biomarkers involved in the sodium-water homeostasis between the interventions throughout the 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 | Observation period of 12 hours | 
| Difference in urinary excretion between the interventions throughout the 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 | Observation period of 12 hours | 
| Change in blood alcohol content between the interventions throughout the 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 | Observation period of 12 hours | 
| Difference in Response to lottery Experiment before and after the intervention | Change in decision making before and after the intervention, comparing the interventions | Directly before and 30 minutes after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Copeptin, Salt-water homeostasis