Alcohol Use Disorder (AUD)GGT-AUDNCT07603726
Multimodal Intervention for GGT Reduction in Alcohol Use Disorder (GGT-AUD)
A study testing Alcohol Reduction Counseling, Nutraceutical Treatment and Psychological Intervention in people with Alcohol Use Disorder (AUD), run by Medical Center TOPMED at 1 site in Romania.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder (AUD)
- What is being tested?
- Alcohol Reduction Counseling, Nutraceutical Treatment and Psychological Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteRomania
- Study dates
- 1 Jan 2024to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Diagnosis of Alcohol Use Disorder
- Elevated baseline gamma-glutamyl transferase (GGT) levels
- Ability to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Use Disorder (AUD)
- Being tested
- Alcohol Reduction Counseling, Nutraceutical Treatment, Psychological Intervention
- Keywords
- Alcohol Use Disorder, Psychological support, Gamma-glutamyl transferase, Nutraceuticals, Alcohol-related liver disease
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol Reduction CounselingBehavioural
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 TreatmentDietary 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 InterventionBehavioural
Participants received structured psychological support designed to reduce alcohol consumption and improve adherence to behavioral recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | Alcohol Reduction Counseling Receives: Behavioral: Alcohol Reduction Counseling |
| Intervention Group | Experimental | 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. Receives: Dietary Supplement: Nutraceutical Treatment; Behavioral: Psychological Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum gamma-glutamyl transferase (GGT) levels
Assessment of changes in serum GGT levels over time to evaluate the effect of the intervention.
Measured: From baseline through follow-up, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jan 2024
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a non-randomized, parallel-assignment interventional study. Participants were allocated into two groups based on baseline gamma-glutamyl transferase (GGT) levels. Participants with GGT levels between 55-99 U/L were assigned to the control group and received standard guidance only. Participants with GGT levels ≥100 U/L were assigned to the intervention group and received a combined nutraceutical and psychological intervention. Outcomes were assessed over time to evaluate changes in GGT levels.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Center TOPMED
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603726
- Sponsor's protocol ID
- 2/2024
- Acronym
- GGT-AUD
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Diana NS, Monica T, Florina G. Multimodal Nutraceutical and Psychological Intervention for GGT Reduction in Individuals with Alcohol Use Disorder. Nutrients. 2026 May 23;18(11):1676. doi: 10.3390/nu18111676.
PubMed 42280319
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Nutraceutical and Psychological Intervention for GGT Reduction in Individuals With Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT07603726
- Acronym / sponsor ID
- GGT-AUD / 2/2024
- Conditions
- Alcohol Use Disorder (AUD)
- Keywords
- Alcohol Use Disorder, Psychological support, Gamma-glutamyl transferase, Nutraceuticals, Alcohol-related liver disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Medical Center TOPMEDUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a non-randomized, parallel-assignment interventional study. Participants were allocated into two groups based on baseline gamma-glutamyl transferase (GGT) levels. Participants with GGT levels between 55-99 U/L were assigned to the control group and received standard guidance only. Participants with GGT levels ≥100 U/L were assigned to the intervention group and received a combined nutraceutical and psychological intervention. Outcomes were assessed over time to evaluate changes in GGT levels.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Behavioral: Alcohol Reduction CounselingAlcohol Reduction Counseling |
| Intervention Group | Experimental | Dietary Supplement: Nutraceutical Treatment, Behavioral: Psychological InterventionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older
- Diagnosis of Alcohol Use Disorder
- Elevated baseline gamma-glutamyl transferase (GGT) levels
- Ability to provide informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol Reduction CounselingParticipants 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. | Behavioural | Control Group |
| Nutraceutical TreatmentParticipants received nutraceutical supplementation aimed at supporting liver function and reducing alcohol-related liver stress. The intervention included compounds commonly used for hepatoprotective support. | Dietary supplement | Intervention Group |
| Psychological InterventionParticipants received structured psychological support designed to reduce alcohol consumption and improve adherence to behavioral recommendations. | Behavioural | Intervention Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Derived from this study: PubMed 42280319Diana NS, Monica T, Florina G. Multimodal Nutraceutical and Psychological Intervention for GGT Reduction in Individuals with Alcohol Use Disorder. Nutrients. 2026 May 23;18(11):1676. doi: 10.3390/nu18111676.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol Reduction Counseling, Nutraceutical Treatment and Psychological Intervention in people with Alcohol Use Disorder (AUD), run by Medical Center TOPMED at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum gamma-glutamyl transferase (GGT) levels (time frame: From baseline through follow-up, assessed up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07603726, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.