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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Other | Alcohol Reduction Counseling |
|
| Intervention Group | Experimental | Participants with baseline gamma-glutamyl transferase (GGT) levels ≥100 U/L who received a combined intervention consisting of nutraceutical treatment and structured psychological support aimed to reduce alcohol consumption and improve liver-related biomarkers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcohol Reduction Counseling | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum gamma-glutamyl transferase (GGT) levels | Assessment of changes in serum GGT levels over time to evaluate the effect of the intervention. | From baseline through follow-up, assessed up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Center TOPMED | Târgu Mureş | Mureș County | 540058 | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42280319 | Derived | Diana NS, Monica T, Florina G. Multimodal Nutraceutical and Psychological Intervention for GGT Reduction in Individuals with Alcohol Use Disorder. Nutrients. 2026 May 23;18(11):1676. doi: 10.3390/nu18111676. |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D000083626 | Psychosocial Intervention |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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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.
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This is an open-label study. No participants, investigators, or outcome assessors were blinded to group assignment.
| Nutraceutical Treatment | Dietary Supplement | Participants received nutraceutical supplementation aimed at supporting liver function and reducing alcohol-related liver stress. The intervention included compounds commonly used for hepatoprotective support. |
|
| Psychological Intervention | Behavioral | Participants received structured psychological support designed to reduce alcohol consumption and improve adherence to behavioral recommendations. |
|