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

Sponsors

Lead Sponsor: University Hospital, Basel, Switzerland

Source University Hospital, Basel, Switzerland
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.

Overall Status Completed
Start Date February 25, 2019
Completion Date April 10, 2019
Primary Completion Date April 10, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Difference in copeptin levels between the interventions 30 minutes after intervention
Secondary Outcome
Measure Time Frame
Change in copeptin levels between the interventions throughout the observation period of 12 hours Observation period of 12 hours
Change in plasma sodium levels between the interventions throughout the observation period of 12 hours Observation period of 12 hours
Change in urinary sodium levels between the interventions throughout the observation period of 12 hours Observation period of 12 hours
Change in plasma osmolality levels between the interventions throughout the observation period of 12 hours Observation period of 12 hours
Change in urinary osmolality levels between the interventions throughout the observation period of 12 hours Observation period of 12 hours
Change in plasma Glucose levels between the interventions throughout the observation period of 12 hours Observation period of 12 hours
Change in biomarkers involved in the sodium-water homeostasis between the interventions throughout the observation period of 12 hours Observation period of 12 hours
Difference in urinary excretion between the interventions throughout the observation period of 12 hours Observation period of 12 hours
Change in blood alcohol content between the interventions throughout the observation period of 12 hours Observation period of 12 hours
Difference in Response to lottery Experiment before and after the intervention Directly before and 30 minutes after intervention
Enrollment 10
Condition
Intervention

Intervention Type: Other

Intervention Name: Beer 5%o

Description: Weight adjusted beer to reach 0.8 blood alcohol content will be given over the time course of 1 hour to the participants

Arm Group Label: Beer alone

Intervention Type: Other

Intervention Name: Beer 8.5%o and water

Description: 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

Arm Group Label: Beer and water

Intervention Type: Other

Intervention Name: Beer 8.5%o and stock

Description: 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

Arm Group Label: Beer and stock

Intervention Type: Other

Intervention Name: Water

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

Arm Group Label: Water alone

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

Gender: Male

Minimum Age: 20 Years

Maximum Age: 40 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Mirjam Christ-Crain, Prof. Dr. MD Principal Investigator University Hospital, Basel, Switzerland
Location
Facility: University Hospital Basel
Location Countries

Switzerland

Verification Date

May 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Beer alone

Type: Experimental

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.

Label: Beer and water

Type: Active Comparator

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.

Label: Beer and stock

Type: Active Comparator

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.

Label: Water alone

Type: Placebo Comparator

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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Basic Science

Masking: None (Open Label)

Source: ClinicalTrials.gov