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临床试验/NCT07603726
NCT07603726已完成不适用

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

Medical Center TOPMED1 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2024年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
197
试验地点
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Participant)

盲法说明

This is an open-label study. No participants, investigators, or outcome assessors were blinded to group assignment.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 years or older
  • Diagnosis of Alcohol Use Disorder
  • Elevated baseline gamma-glutamyl transferase (GGT) levels
  • Ability to provide informed consent

排除标准

  • 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

研究者

发起方
Medical Center TOPMED
申办方类型
Other
责任方
Sponsor

研究点 (1)

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