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

May 14, 2019 updated by: University Hospital, Basel, Switzerland

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
30 minutes after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Observation period of 12 hours
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
Observation period of 12 hours
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
Observation period of 12 hours
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
Observation period of 12 hours
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
Observation period of 12 hours
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
Observation period of 12 hours
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
Observation period of 12 hours
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
Observation period of 12 hours
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
Observation period of 12 hours
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
Directly before and 30 minutes after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mirjam Christ-Crain, Prof. Dr. MD, University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 10, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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