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

Alcohol Drinking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03883503
• Other study ID #: CASCO
• Status: Completed
• Phase: N/A
• Start date: February 25, 2019
• Est. completion date: April 10, 2019

Study information

• Verified date: May 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 10, 2019
• Est. primary completion date: April 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Diabetes Insipidus

Intervention

Other:
• Beer 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
• Beer 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
• Beer 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
• Water
Water equivalent to the calculated volume of beer will be given over the time course of 1 hour to the participants

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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