Multimodal Intervention for GGT Reduction in Alcohol Use Disorder (GGT-AUD) (GGT-AUD)
Multimodal Nutraceutical and Psychological Intervention for GGT Reduction in Individuals With Alcohol Use Disorder
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Mureș County
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Târgu Mureş, Mureș County, Rumania, 540058
- Medical Center TOPMED
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Poner en pantalla
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Control Group
Alcohol 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.
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|
Experimental: Intervention Group
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.
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Participants received nutraceutical supplementation aimed at supporting liver function and reducing alcohol-related liver stress.
The intervention included compounds commonly used for hepatoprotective support.
Participants received structured psychological support designed to reduce alcohol consumption and improve adherence to behavioral recommendations.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in serum gamma-glutamyl transferase (GGT) levels
Periodo de tiempo: From baseline through follow-up, assessed up to 12 months
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Assessment of changes in serum GGT levels over time to evaluate the effect of the intervention.
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From baseline through follow-up, assessed up to 12 months
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2/2024
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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