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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Mureș County
-
Târgu Mureş, Mureș County, Roumanie, 540058
- Medical Center TOPMED
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Dépistage
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: 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.
|
|
Expérimental: 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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in serum gamma-glutamyl transferase (GGT) levels
Délai: 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.
|
From baseline through follow-up, assessed up to 12 months
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2/2024
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .