Multimodal Intervention for GGT Reduction in Alcohol Use Disorder (GGT-AUD) (GGT-AUD)

May 16, 2026 updated by: Medical Center TOPMED

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

197

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
    • Mureș County
      • Târgu Mureş, Mureș County, Romania, 540058
        • Medical Center TOPMED

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control Group
Alcohol Reduction Counseling
Behavioral: 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.
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.
Dietary supplement: Nutraceutical 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.
Behavioral: Psychological Intervention
Participants received structured psychological support designed to reduce alcohol consumption and improve adherence to behavioral recommendations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum gamma-glutamyl transferase (GGT) levels
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Center TOPMED

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

April 1, 2026

Study Completion (Actual)

April 1, 2026

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

May 16, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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