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

NCT ID: NCT03883503

Last Updated: 2019-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-25

Study Completion Date

2019-04-10

Brief Summary

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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.

Detailed Description

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Conditions

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Alcohol Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Beer 5%o

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

Beer 8.5%o and water

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

Beer 8.5%o and stock

Intervention Type 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 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.

Group Type PLACEBO_COMPARATOR

Water

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

Water

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mirjam Christ-Crain, Prof. Dr. MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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University Hospital Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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CASCO

Identifier Type: -

Identifier Source: org_study_id

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