Evaluate effects of one month alcohol abstinence in a healthy population of moderate drinkers.
ID
Source
Brief title
Condition
- Other condition
- Hepatic and hepatobiliary disorders
- Lifestyle issues
Synonym
Health condition
lichamelijke en psychische gezondheid
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proportional decrease in liver steatosis after intervention
Secondary outcome
Proportional decrease in liver steatosis at week 8
Proportional decrease in liver stiffness at week 4, 8
Proportional decrease in body weight, fatpercentage, bloodpressure at week 4.8
Proportional decrease in glucose and cholesterolspectrum at week 4,8
Proportional decrease in liverenzymes at week 4,8
Proportional improvement in sleep quality at week 4,8
Proportional improvement in ability to concentrate at week 4,8
Proportional improvement in ability to enjoy oneself at week 4,8
Proportional change in lifestyle at week 4,8
Proportional decrease in alcohol intake at week 8
Difference between intervention and controlgroup for all above listed variables
at week 0,4,8
Background summary
Excessive alcohol use is a growing problem in the Western world. Alcohol is
processed in the liver. Therefore the liver can be damaged. This damage is an
effect of the direct toxic effect of alcohol on the livercells (=hepatitis).
Furthermore alcohol leads to fat accumalation in the liver (=steatosis). This
fat also leads to inflammation. After prolonged damage scarring of the liver
can occur (=fibrosis).
Other processes in the body are also negatively influenced by excessive alcohol
intake. It can lead to obesity, cardiovasvcular disease, diabetes, and mental
problems. If alcohol intake is cessated these effects are reversable with many
people.
In people with moderate alcohol intake (short) abstinence of alcohol intake may
also lead to possitive health effects, as shown in recent cohorts (ref 1,2).
The sustainability of these effects has not yet been thoroughly studied.
References
1.
https://www.newscientist.com/article/mg22129502-600-our-liver-vacation-is-a-dry-
january-really-worth-it/
2. http://onlinelibrary.wiley.com/doi/10.1002/hep.28184/full Abstract 113;
AASLD 2015
Study objective
Evaluate effects of one month alcohol abstinence in a healthy population of
moderate drinkers.
Study design
Prospective cohort study of 10 healthy volunteers that undergo intervention
(one month alcohol abstinence) with control group of 10 healthy volunteers who
never consume alcohol. All volunteers undergo several investigations before
intervention (t=0), after intervention (t=4) and after additional follow-up of
4 weeks (t=8).
Variables:
-body weight, fat percentage, blood pressure
-Liver steatosis measurement (CAUS)
-Liverstiffness (Fibroscan)
-Glucose, HbA1C, plasma insuline, C-peptide
-Cholesterol spectrum + triglycerides
-Liverenzymes
-CDT
-hemocytometry
-iron, hepcidin, ferritin, transferrin saturation, C-reactive protein
- Na, K, Kreat, U, Mg
-TSH, FT4
Questionnaires:
-Alcohol intake: quantification, AUDIT-C, CAGE
-Evaluation lifestyle: SLIQ
Cognitive function:
-Quality of sleep: PSQI
-Concentration
-Self-assessment ability to enjoy oneself: SHAPS
Intervention
one month alcohol abstinence
Study burden and risks
Three visits of 1-2 hours to hospital for tests. Discomfort from blood
withdrawal (pain, hematoma).
Possibility of unexpected findings from tests that require medical attention.
Geert-Grooteplein Zuid 10
Nijmegen 6500 HB
NL
Geert-Grooteplein Zuid 10
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
above 18 years
mentally competent
Exclusion criteria
-pregnant or lactating
-known liver disease
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL56238.091.15 |