Clinical trial NCT03883503: The Influence of Water and Salt Intake on Copeptin Levels During Moderate Alcohol Consumption
Official title: The Influence of Water and Salt Intake on Copeptin Levels During Moderate Alcohol Consumption - a Pathophysiological Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Keywords: Copeptin
Salt-water homeostasis
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 10
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in copeptin levels between the interventions
timeFrame: 30 minutes after intervention
Secondary outcomes:
measure: Change in copeptin levels between the interventions throughout the observation period of 12 hours
timeFrame: Observation period of 12 hours
measure: Change in plasma sodium levels between the interventions throughout the observation period of 12 hours
timeFrame: Observation period of 12 hours
measure: Change in urinary sodium levels between the interventions throughout the observation period of 12 hours
timeFrame: Observation period of 12 hours
measure: Change in plasma osmolality levels between the interventions throughout the observation period of 12 hours
timeFrame: Observation period of 12 hours
measure: Change in urinary osmolality levels between the interventions throughout the observation period of 12 hours
timeFrame: Observation period of 12 hours
measure: Change in plasma Glucose levels between the interventions throughout the observation period of 12 hours
timeFrame: Observation period of 12 hours
measure: Change in biomarkers involved in the sodium-water homeostasis between the interventions throughout the observation period of 12 hours
timeFrame: Observation period of 12 hours
measure: Difference in urinary excretion between the interventions throughout the observation period of 12 hours
timeFrame: Observation period of 12 hours
measure: Change in blood alcohol content between the interventions throughout the observation period of 12 hours
timeFrame: Observation period of 12 hours
measure: Difference in Response to lottery Experiment before and after the intervention
timeFrame: Directly before and 30 minutes after intervention
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Mirjam Christ-Crain, Prof. Dr. MD
role: PRINCIPAL_INVESTIGATOR
References: