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

University Hospital Basel

Status: Completed

Conditions: Alcohol Drinking

Treatments: Other: Water; Other: Beer 8.5%o and stock; Other: Beer 8.5%o and water; Other: Beer 5%o

Study type: Interventional

Funder types: Other

Identifiers

NCT03883503

CASCO

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 4 patient groups, including a placebo group

Beer alone

Experimental group

Description:

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.

Treatment:

Other: Beer 5%o

Beer and water

Active Comparator group

Description:

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.

Treatment:

Other: Beer 8.5%o and water

Beer and stock

Active Comparator group

Description:

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.

Treatment:

Other: Beer 8.5%o and stock

Water alone

Placebo Comparator group

Description:

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.

Treatment:

Other: Water