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Completed

NCT Number: NCT03883503

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

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.

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Key information

Conditions

Alcohol Drinking Behavior Diabetes Insipidus Drinking Behavior Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pituitary Diseases Urogenital Diseases Urologic Diseases

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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 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

Water

Other

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

Primary outcomes

  1. Difference in copeptin levels between the interventions

    Time frame: 30 minutes after intervention

    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 outcomes

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

    Time frame: 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

  2. Change in plasma sodium levels between the interventions throughout the observation period of 12 hours

    Time frame: 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

  3. Change in urinary sodium levels between the interventions throughout the observation period of 12 hours

    Time frame: 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

  4. Change in plasma osmolality levels between the interventions throughout the observation period of 12 hours

    Time frame: 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

  5. Change in urinary osmolality levels between the interventions throughout the observation period of 12 hours

    Time frame: 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

  6. Change in plasma Glucose levels between the interventions throughout the observation period of 12 hours

    Time frame: 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

  7. Change in biomarkers involved in the sodium-water homeostasis between the interventions throughout the observation period of 12 hours

    Time frame: 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

  8. Difference in urinary excretion between the interventions throughout the observation period of 12 hours

    Time frame: 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

  9. Change in blood alcohol content between the interventions throughout the observation period of 12 hours

    Time frame: 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

  10. Difference in Response to lottery Experiment before and after the intervention

    Time frame: Directly before and 30 minutes after intervention

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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 21, 2019
Registry last updated
May 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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