Alcohol DrinkingNCT03883503
The Influence of Water and Salt Intake on Copeptin Levels During Moderate Alcohol Consumption
A study testing Beer 5%o, Beer 8.5%o and water and Beer 8.5%o and stock in people with Alcohol Drinking, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Beer 5%o, Beer 8.5%o and water and Beer 8.5%o and stock
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Feb 2019to 10 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Alcohol Drinking
- Being tested
- Beer 5%o, Beer 8.5%o and water, Beer 8.5%o and stock, Water
- Keywords
- Copeptin, Salt-water homeostasis
- Medical subject headings
- Alcohol Drinking, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beer 5%oOther
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 waterOther
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 stockOther
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
WaterOther
Water equivalent to the calculated volume of beer will be given over the time course of 1 hour to the participants
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes after intervention
Secondary outcomes (10)
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
Measured: Observation period of 12 hours
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
Measured: Observation period of 12 hours
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
Measured: Observation period of 12 hours
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
Measured: Observation period of 12 hours
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
Measured: Observation period of 12 hours
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
Measured: Observation period of 12 hours
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
Measured: Observation period of 12 hours
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
Measured: Observation period of 12 hours
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
Measured: Observation period of 12 hours
Difference in Response to lottery Experiment before and after the intervention
Change in decision making before and after the intervention, comparing the interventions
Measured: Directly before and 30 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start25 Feb 2019
- Primary completion10 Apr 2019
- Study completion10 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirjam Christ-Crain, Prof. Dr. MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883503
- Sponsor's protocol ID
- CASCO
- Status last verified
- May 2019
- First submitted
- 13 Mar 2019
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Water and Salt Intake on Copeptin Levels During Moderate Alcohol Consumption - a Pathophysiological Study
- ClinicalTrials.gov ID
- NCT03883503
- Acronym / sponsor ID
- CASCO
- Conditions
- Alcohol Drinking
- Keywords
- Copeptin, Salt-water homeostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 10 Apr 2019 (actual)
- Study completion
- 10 Apr 2019 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Beer alone | Experimental | Other: Beer 5%oConsumption 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. |
| Beer and water | Active comparator | Other: Beer 8.5%o and waterConsumption 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. |
| Beer and stock | Active comparator | Other: Beer 8.5%o and stockConsumption 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. |
| Water alone | Placebo comparator | Other: WaterConsumption 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy males
Key exclusion criteria (10 listed)
- Any acute or chronic illness
- History of alcohol dependency
- Alcohol consumption >2 units/day
- Active nicotine abuse
- Gluten intolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beer 5%oWeight adjusted beer to reach 0.8 blood alcohol content will be given over the time course of 1 hour to the participants | Other | Beer alone |
| Beer 8.5%o and waterWeight adjusted beer to reach 0.8 blood alcohol content and water will be given over the time course of 1 hour to the participants | Other | Beer and water |
| Beer 8.5%o and stockWeight adjusted beer to reach 0.8 blood alcohol content and stock will be given over the time course of 1 hour to the participants | Other | Beer and stock |
| WaterWater equivalent to the calculated volume of beer will be given over the time course of 1 hour to the participants | Other | Water alone |
Primary outcome
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.
10 secondary outcomes
Change in copeptin levels between the interventions throughout the observation period of 12 hours
Time frame: 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 urinary sodium levels between the interventions throughout the observation period of 12 hours
Time frame: 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 urinary osmolality levels between the interventions throughout the observation period of 12 hours
Time frame: 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 biomarkers involved in the sodium-water homeostasis between the interventions throughout the observation period of 12 hours
Time frame: 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
Change in blood alcohol content between the interventions throughout the observation period of 12 hours
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirjam Christ-Crain, Prof. Dr. MD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beer 5%o, Beer 8.5%o and water and Beer 8.5%o and stock in people with Alcohol Drinking, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in copeptin levels between the interventions (time frame: 30 minutes after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.