Alcohol Use Disorder (AUD)
Conditions
Keywords
Alcohol Use Disorder, Psychological support, Gamma-glutamyl transferase, Nutraceuticals, Alcohol-related liver disease
Brief summary
The aim of this clinical trial is to evaluate whether a combined nutraceutical and psychological intervention can reduce gamma-glutamyl transferase (GGT) levels in individuals with Alcohol Use Disorder (AUD). The main question it seeks to answer is: • Does this combined intervention lead to a reduction in GGT levels over time? Participants with Alcohol Use Disorder and elevated GGT levels were included in the study. Participants will: * Receive nutraceutical supplements aimed at supporting liver function * Participate in psychological support sessions to help reduce alcohol consumption * Have their GGT levels monitored over time.
Detailed description
Alcohol Use Disorder (AUD) is commonly associated with liver dysfunction, which can be reflected by elevated levels of gamma-glutamyl transferase (GGT). Monitoring changes in GGT levels may provide useful information about liver status and response to interventions aimed at reducing alcohol-related harm. This study evaluates a multimodal approach that combines nutraceutical support with psychological intervention in individuals with AUD and elevated GGT levels. The rationale for this combined approach is to address both the biological and behavioral components of alcohol use. Participants were included based on the presence of Alcohol Use Disorder and elevated baseline GGT levels. For analysis purposes, participants were stratified according to baseline GGT values (55-99 U/L and ≥100 U/L). The study focuses on assessing changes in GGT levels over time following the intervention. Additional analyses explore variations in response based on baseline GGT levels. This study aims to contribute to the understanding of integrated approaches for improving liver-related biomarkers in individuals with Alcohol Use Disorder.
Interventions
BEHAVIORALAlcohol Reduction Counseling
Participants received structured counseling focused on reducing alcohol consumption and improving lifestyle behaviors. The intervention included educational guidance and recommendations regarding alcohol use and general health.
DIETARY_SUPPLEMENTNutraceutical Treatment
Participants received nutraceutical supplementation aimed at supporting liver function and reducing alcohol-related liver stress. The intervention included compounds commonly used for hepatoprotective support.
BEHAVIORALPsychological Intervention
Participants received structured psychological support designed to reduce alcohol consumption and improve adherence to behavioral recommendations.
Sponsors
Medical Center TOPMED
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Masking description
This is an open-label study. No participants, investigators, or outcome assessors were blinded to group assignment.
Intervention model description
This is a non-randomized, parallel-assignment interventional study. Participants were allocated into two groups based on baseline gamma-glutamyl transferase (GGT) levels. Participants with GGT levels between 55-99 U/L were assigned to the control group and received standard guidance only. Participants with GGT levels ≥100 U/L were assigned to the intervention group and received a combined nutraceutical and psychological intervention. Outcomes were assessed over time to evaluate changes in GGT levels.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older * Diagnosis of Alcohol Use Disorder * Elevated baseline gamma-glutamyl transferase (GGT) levels * Ability to provide informed consent
Exclusion criteria
* Severe liver disease (e.g., cirrhosis or hepatic failure) * Severe psychiatric disorders interfering with participation * Current participation in another clinical study * Incomplete clinical or laboratory data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum gamma-glutamyl transferase (GGT) levels | From baseline through follow-up, assessed up to 12 months | Assessment of changes in serum GGT levels over time to evaluate the effect of the intervention. |
Countries
Romania
Outcome results
None listed