MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)GLUT-FNCT07724067
GLUT-F Improves MASLD Liver Function
A study testing GLUTatios FOrte in people with MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), run by University of Bari at 1 site in Italy.
Trial summary
This randomized, double-blind, placebo-controlled, two-period crossover study evaluated the effects of GLUT-F, a nutraceutical formulation containing silibin-enriched silymarin, glutathione, and vitamin E delivered with Enterosoma® technology, in adults with metabolic dysfunction-associated steatotic liver disease… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
- What is being tested?
- GLUTatios FOrte
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2024to 15 May 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Evidence of hepatic steatosis (≥ grade 1) at screening.
- Body mass index (BMI) ≥25 kg/m² or presence of metabolic dysfunction consistent with MASLD diagnostic criteria.
- Stable body weight (no significant weight change during the 3 months preceding enrollment).
- Willingness to maintain usual dietary habits, physical activity, and concomitant medications throughout the study.
- Ability to provide written informed consent.
Who cannot join
- Excessive alcohol consumption (>30 g/day for men or >20 g/day for women). Other known causes of chronic liver disease, including viral hepatitis (HBV or HCV), autoimmune liver disease, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, or drug-induced liver disease.
- Evidence of liver cirrhosis, hepatic decompensation, hepatocellular carcinoma, or other severe liver disorders.
- Previous bariatric surgery or planned bariatric surgery during the study period.
- Current use of medications or nutritional supplements known to significantly affect hepatic steatosis or liver function unless on a stable dose for at least 3 months before enrollment.
- Pregnancy or breastfeeding.
- Severe renal, cardiovascular, respiratory, endocrine, or malignant disease that could interfere with study participation.
- Known allergy or hypersensitivity to silybin, glutathione, vitamin E, or any component of the study product.
- Any condition that, in the investigator's judgment, could compromise participant safety or adherence to the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Enterosoma-delivered Silibin and Glutathione-based Supplementation on Hepatic Steatosis and Liver Function in Patients With MASLD: a Randomized, Double-blind, Placebo-controlled Crossover Clinical Trial
This randomized, double-blind, placebo-controlled, two-period crossover study evaluated the effects of GLUT-F, a nutraceutical formulation containing silibin-enriched silymarin, glutathione, and vitamin E delivered with Enterosoma® technology, in adults with metabolic dysfunction-associated steatotic liver disease (MASLD). Participants received GLUT-F and placebo for 3 months each, separated by a 1-month washout period. The study assessed changes in hepatic steatosis, liver enzymes, metabolic parameters, inflammatory markers, and liver function measured by ultrasonography and the ^13C-methacetin breath test.
Read the detailed description
Background
Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease worldwide and is closely associated with obesity, insulin resistance, oxidative stress, and chronic low-grade inflammation. Although lifestyle modification remains the cornerstone of treatment, adherence is often poor and effective pharmacological therapies remain limited. GLUT-F is a nutraceutical formulation containing silibin-enriched silymarin, glutathione, and vitamin E encapsulated using Enterosoma® technology to improve the bioavailability of its active components. The combined antioxidant and hepatoprotective properties of these compounds may reduce hepatic steatosis and improve liver function in patients with MASLD.
Objectives
The primary objective was to evaluate the effect of GLUT-F supplementation on hepatic steatosis compared with placebo in adults with MASLD. Secondary objectives were to assess the effects of GLUT-F on liver metabolic function, liver enzymes, anthropometric measures, glucose metabolism, lipid profile, inflammatory biomarkers, and hepatic fibrosis.
Methods
This was a randomized, double-blind, placebo-controlled, two-period crossover clinical trial. Following a 2-week dietary run-in period, participants with ultrasonographically diagnosed MASLD were randomly assigned to receive either GLUT-F or matching placebo for 3 months. After a 1-month washout period, participants crossed over to receive the alternate treatment for an additional 3 months. Throughout the study, participants were instructed to maintain their habitual lifestyle and consume an isocaloric diet.
Clinical assessments were performed at baseline and at the end of each treatment period. Liver steatosis was assessed by ultrasonographic steatosis grading and the hepatorenal index (HRI), while liver stiffness was evaluated by acoustic radiation force impulse (ARFI) elastography. Dynamic liver function was assessed using the ¹³C-methacetin breath test (¹³C-MBT), including cumulative percent dose recovery (cPDR) and delta over baseline (DOB). Additional assessments included anthropometric measurements, serum liver enzymes (ALT, AST, GGT), hepatic steatosis indices (HSI and FLI), fasting glucose, insulin, HOMA-IR, lipid profile, C-reactive protein, and a panel of inflammatory and metabolic mediators.
The primary endpoint was the change in hepatic steatosis assessed by ultrasonography. Secondary endpoints included changes in liver function, liver enzymes, metabolic and inflammatory biomarkers, and safety. Treatment effects were analyzed using linear mixed-effects models accounting for treatment, period, sequence, and baseline values, with participants included as random effects.
- Being tested
- GLUTatios FOrte, Placebo
- Keywords
- Hepatic steatosis, Nutraceutical, Silybin, Glutathione, Vitamin E, Liver function
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLUTatios FOrteDietary supplement
GLUT-F is an oral nutraceutical formulation containing silibin-enriched silymarin, reduced glutathione, and vitamin E encapsulated using Enterosoma® technology to enhance intestinal absorption and bioavailability. Participants received one sachet daily for 3 months. The placebo was identical in appearance, taste, and packaging but contained no active ingredients.
PlaceboDietary supplement
The placebo consisted of an oral formulation identical to GLUT-F in appearance, taste, packaging, and mode of administration, but containing no active ingredients. It was administered as one sachet daily for 3 months to maintain participant and investigator blinding.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Treatment | Experimental | Not described Receives: Dietary Supplement: GLUTatios FOrte |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver steatosis grade
Change in liver steatosis grade from baseline to the end of each treatment period, assessed by abdominal ultrasonography using a standardized semiquantitative steatosis grading system and the hepatorenal index (HRI), which quantifies hepatic echogenicity relative to the renal cortex. Lower steatosis grade and HRI values indicate improvement in hepatic fat accumulation.
Measured: At baseline and at the end of intervention (3 months)
Secondary outcomes (2)
Liver function
Change from baseline to the end of each treatment period in liver metabolic function assessed by the ¹³C-methacetin breath test. Functional parameters included cumulative percent dose recovery (cPDR), reflecting hepatic microsomal metabolic capacity, and delta over baseline (DOB), reflecting hepatic substrate extraction and metabolism. Higher cPDR and normalization of abnormal cPDR or DOB values indicate improved liver function.
Measured: At baseline and after the end of intervention (3 months)
Change in Liver Enzyme Levels
To evaluate the change in liver enzyme levels from baseline to the end of the treatment period. Liver function will be assessed by measuring serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT). Results will be reported as mean change from baseline and compared between treatment groups.
Measured: At baseline and after the intervention (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 May 2024
- Primary completion10 Sep 2025
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double-blind, placebo-controlled, two-period crossover study. Participants were randomly assigned to receive either GLUT-F followed by placebo or placebo followed by GLUT-F, with each intervention lasting 3 months and separated by a 1-month washout period. Each participant served as their own control.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, piero portincasa, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724067
- Sponsor's protocol ID
- GLUT-FORTE2025
- Acronym
- GLUT-F
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Portincasa P, Khalil M, Mahdi L, Perniola V, Idone V, Graziani A, Baffy G, Di Ciaula A. Metabolic Dysfunction-Associated Steatotic Liver Disease: From Pathogenesis to Current Therapeutic Options. Int J Mol Sci. 2024 May 22;25(11):5640. doi: 10.3390/ijms25115640.
PubMed 38891828Abdallah H, Khalil M, Awada E, Lanza E, Di Ciaula A, Portincasa P. Metabolic dysfunction-associated steatotic liver disease (MASLD). Assessing metabolic dysfunction, cardiovascular risk factors, and lifestyle habits. Eur J Intern Med. 2025 Aug;138:101-111. doi: 10.1016/j.ejim.2025.05.018. Epub 2025 May 27.
PubMed 40436716
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Enterosoma-delivered Silibin and Glutathione-based Supplementation on Hepatic Steatosis and Liver Function in Patients With MASLD: a Randomized, Double-blind, Placebo-controlled Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT07724067
- Acronym / sponsor ID
- GLUT-F / GLUT-FORTE2025
- Keywords
- Hepatic steatosis, Nutraceutical, Silybin, Glutathione, Vitamin E, Liver function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 23 Jul 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.
This randomized, double-blind, placebo-controlled, two-period crossover study evaluated the effects of GLUT-F, a nutraceutical formulation containing silibin-enriched silymarin, glutathione, and vitamin E delivered with Enterosoma® technology, in adults with metabolic dysfunction-associated steatotic liver disease (MASLD). Participants received GLUT-F and placebo for 3 months each, separated by a 1-month washout period. The study assessed changes in hepatic steatosis, liver enzymes, metabolic parameters, inflammatory markers, and liver function measured by ultrasonography and the ^13C-methacetin breath test.
Detailed description
Background
Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease worldwide and is closely associated with obesity, insulin resistance, oxidative stress, and chronic low-grade inflammation. Although lifestyle modification remains the cornerstone of treatment, adherence is often poor and effective pharmacological therapies remain limited. GLUT-F is a nutraceutical formulation containing silibin-enriched silymarin, glutathione, and vitamin E encapsulated using Enterosoma® technology to improve the bioavailability of its active components. The combined antioxidant and hepatoprotective properties of these compounds may reduce hepatic steatosis and improve liver function in patients with MASLD.
Objectives
The primary objective was to evaluate the effect of GLUT-F supplementation on hepatic steatosis compared with placebo in adults with MASLD. Secondary objectives were to assess the effects of GLUT-F on liver metabolic function, liver enzymes, anthropometric measures, glucose metabolism, lipid profile, inflammatory biomarkers, and hepatic fibrosis.
Methods
This was a randomized, double-blind, placebo-controlled, two-period crossover clinical trial. Following a 2-week dietary run-in period, participants with ultrasonographically diagnosed MASLD were randomly assigned to receive either GLUT-F or matching placebo for 3 months. After a 1-month washout period, participants crossed over to receive the alternate treatment for an additional 3 months. Throughout the study, participants were instructed to maintain their habitual lifestyle and consume an isocaloric diet.
Clinical assessments were performed at baseline and at the end of each treatment period. Liver steatosis was assessed by ultrasonographic steatosis grading and the hepatorenal index (HRI), while liver stiffness was evaluated by acoustic radiation force impulse (ARFI) elastography. Dynamic liver function was assessed using the ¹³C-methacetin breath test (¹³C-MBT), including cumulative percent dose recovery (cPDR) and delta over baseline (DOB). Additional assessments included anthropometric measurements, serum liver enzymes (ALT, AST, GGT), hepatic steatosis indices (HSI and FLI), fasting glucose, insulin, HOMA-IR, lipid profile, C-reactive protein, and a panel of inflammatory and metabolic mediators.
The primary endpoint was the change in hepatic steatosis assessed by ultrasonography. Secondary endpoints included changes in liver function, liver enzymes, metabolic and inflammatory biomarkers, and safety. Treatment effects were analyzed using linear mixed-effects models accounting for treatment, period, sequence, and baseline values, with participants included as random effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, two-period crossover study. Participants were randomly assigned to receive either GLUT-F followed by placebo or placebo followed by GLUT-F, with each intervention lasting 3 months and separated by a 1-month washout period. Each participant served as their own control.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| Treatment | Experimental | Dietary Supplement: GLUTatios FOrte |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Evidence of hepatic steatosis (≥ grade 1) at screening.
- Body mass index (BMI) ≥25 kg/m² or presence of metabolic dysfunction consistent with MASLD diagnostic criteria.
- Stable body weight (no significant weight change during the 3 months preceding enrollment).
- Willingness to maintain usual dietary habits, physical activity, and concomitant medications throughout the study.
- Ability to provide written informed consent.
Key exclusion criteria (8 listed)
- Excessive alcohol consumption (>30 g/day for men or >20 g/day for women). Other known causes of chronic liver disease, including viral hepatitis (HBV or HCV), autoimmune liver disease, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, or drug-induced liver disease.
- Evidence of liver cirrhosis, hepatic decompensation, hepatocellular carcinoma, or other severe liver disorders.
- Previous bariatric surgery or planned bariatric surgery during the study period.
- Current use of medications or nutritional supplements known to significantly affect hepatic steatosis or liver function unless on a stable dose for at least 3 months before enrollment.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| GLUTatios FOrteGLUT-F is an oral nutraceutical formulation containing silibin-enriched silymarin, reduced glutathione, and vitamin E encapsulated using Enterosoma® technology to enhance intestinal absorption and bioavailability. Participants received one sachet daily for 3 months. The placebo was identical in appearance, taste, and packaging but contained no active ingredients. | Dietary supplement | Treatment |
| PlaceboThe placebo consisted of an oral formulation identical to GLUT-F in appearance, taste, packaging, and mode of administration, but containing no active ingredients. It was administered as one sachet daily for 3 months to maintain participant and investigator blinding. | Dietary supplement | Placebo |
Primary outcome
Liver steatosis grade
Time frame: At baseline and at the end of intervention (3 months)
Change in liver steatosis grade from baseline to the end of each treatment period, assessed by abdominal ultrasonography using a standardized semiquantitative steatosis grading system and the hepatorenal index (HRI), which quantifies hepatic echogenicity relative to the renal cortex. Lower steatosis grade and HRI values indicate improvement in hepatic fat accumulation.
2 secondary outcomes
Liver function
Time frame: At baseline and after the end of intervention (3 months)
Change in Liver Enzyme Levels
Time frame: At baseline and after the intervention (3 months)
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 23 Jul 2026.
- Background: PubMed 38891828Portincasa P, Khalil M, Mahdi L, Perniola V, Idone V, Graziani A, Baffy G, Di Ciaula A. Metabolic Dysfunction-Associated Steatotic Liver Disease: From Pathogenesis to Current Therapeutic Options. Int J Mol Sci. 2024 May 22;25(11):5640. doi: 10.3390/ijms25115640.
- Background: PubMed 40436716Abdallah H, Khalil M, Awada E, Lanza E, Di Ciaula A, Portincasa P. Metabolic dysfunction-associated steatotic liver disease (MASLD). Assessing metabolic dysfunction, cardiovascular risk factors, and lifestyle habits. Eur J Intern Med. 2025 Aug;138:101-111. doi: 10.1016/j.ejim.2025.05.018. Epub 2025 May 27.
- Individual participant dataSharing planned: Undecided
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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 GLUTatios FOrte in people with MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), run by University of Bari at 1 site in Italy.
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 5 inclusion and 8 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 23 Jul 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 Italy. 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. Some participants in this study may receive a placebo. 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?
Liver steatosis grade (time frame: At baseline and at the end of intervention (3 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 NCT07724067, which also lists 2 linked publications.
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 23 Jul 2026.