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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Mureș County
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Târgu Mureş, Mureș County, Roemenië, 540058
- Medical Center TOPMED
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Screening
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Ander: Control Group
Alcohol Reduction Counseling
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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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Experimenteel: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in serum gamma-glutamyl transferase (GGT) levels
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2/2024
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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