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Completed

NCT Number: NCT07603726

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Center TOPMED

Târgu Mureş, Mureș County, 540058, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Medical Center TOPMED

Other

Registry information

Official study title

Multimodal Nutraceutical and Psychological Intervention for GGT Reduction in Individuals With Alcohol Use Disorder

Acronym: GGT-AUD

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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