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

NCT03883503 | Completed DMC

• 1 other identifier: CASCO
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking

Keywords

Copeptin; Salt-water homeostasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

Study Arms (4)

Beer alone

EXPERIMENTAL

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

Beer and water

ACTIVE COMPARATOR

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

Beer and stock

ACTIVE COMPARATOR

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

Water alone

PLACEBO COMPARATOR

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

Interventions

Beer 5%o OTHER

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

Beer alone

Beer 8.5%o and water OTHER

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 and water

Beer 8.5%o and stock OTHER

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

Beer and stock

Water OTHER

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

Water alone

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Alcohol Drinking; Diabetes Insipidus

Interventions

Water

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Mirjam Christ-Crain, Prof. Dr. MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 21, 2019
• Study Start: February 25, 2019
• Primary Completion: April 10, 2019
• Study Completion: April 10, 2019
• Last Updated: May 15, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)