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

Primary Purpose

Alcohol Drinking

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Beer 5%o

Beer 8.5%o and water

Beer 8.5%o and stock

Water

About this trial

This is an interventional basic science trial for Alcohol Drinking focused on measuring Copeptin, Salt-water homeostasis

Eligibility Criteria

20 Years - 40 Years (Adult)MaleAccepts 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

Sites / Locations

University Hospital Basel

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Beer alone

Beer and water

Beer and stock

Water alone

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

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

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

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

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

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

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

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

Difference in Response to lottery Experiment before and after the intervention

Change in decision making before and after the intervention, comparing the interventions

Full Information

NCT ID

NCT03883503

First Posted

March 13, 2019

Last Updated

May 14, 2019

Sponsor

University Hospital, Basel, Switzerland

1. Study Identification

Unique Protocol Identification Number

NCT03883503

Brief Title

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

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

February 25, 2019 (Actual)

Primary Completion Date

April 10, 2019 (Actual)

Study Completion Date

April 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Drinking

Keywords

Copeptin, Salt-water homeostasis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Beer alone

Arm Type

Experimental

Arm Description

Arm Title

Beer and water

Arm Type

Active Comparator

Arm Description

Arm Title

Beer and stock

Arm Type

Active Comparator

Arm Description

Arm Title

Water alone

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Beer 5%o

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Beer 8.5%o and water

Intervention 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

Intervention Type

Other

Intervention Name(s)

Beer 8.5%o and stock

Intervention 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

Intervention Type

Other

Intervention Name(s)

Water

Intervention Description

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

Primary Outcome Measure Information:

Title

Difference in copeptin levels between the interventions

Description

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.

Time Frame

30 minutes after intervention

Secondary Outcome Measure Information:

Title

Change in copeptin levels between the interventions throughout the observation period of 12 hours

Description

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

Time Frame