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

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

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Drinking
• Intervention / Treatment: Other: Beer 5%o; Other: Beer 8.5%o and water; Other: Beer 8.5%o and stock; Other: Water

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Beer alone; 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; Weight adjusted beer to reach 0.8 blood alcohol content will be given over the time course of 1 hour to the participants
ACTIVE_COMPARATOR: Beer and water; 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; 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
ACTIVE_COMPARATOR: Beer and stock; 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; 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
PLACEBO_COMPARATOR: Water alone; 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; Water equivalent to the calculated volume of beer will be given over the time course of 1 hour to the participants

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Mirjam Christ-Crain, Prof. Dr. MD, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 25, 2019
• Primary Completion (ACTUAL): April 10, 2019
• Study Completion (ACTUAL): April 10, 2019

Study Registration Dates

• First Submitted: March 13, 2019
• First Submitted That Met QC Criteria: March 18, 2019
• First Posted (ACTUAL): March 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 15, 2019
• Last Update Submitted That Met QC Criteria: May 14, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Copeptin; Salt-water homeostasis
• Additional Relevant MeSH Terms: Drinking Behavior; Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Pituitary Diseases; Alcohol Drinking; Diabetes Insipidus
• Other Study ID Numbers: CASCO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No