GLUT-F Improves MASLD Liver Function

NCT07724067 | Completed

• 1 other identifier: GLUT-FORTE2025
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)

Keywords

Hepatic steatosis; Nutraceutical; Silybin; Glutathione; Vitamin E; Liver function

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline and at the end of intervention (3 months)

Secondary Outcomes (2)

• Liver function

  At baseline and after the end of intervention (3 months)

• Change in Liver Enzyme Levels

  At baseline and after the intervention (3 months)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Treatment

EXPERIMENTAL

Dietary Supplement: GLUTatios FOrte

Interventions

Placebo DIETARY_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.

Placebo

GLUTatios FOrte DIETARY_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.

Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bari: lead

Study Sites (1)

University of Bari

Bari, 70124, Italy

Location

Related Publications (2)

• 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.

  PMID: 38891828 BACKGROUND

• Abdallah 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.

  PMID: 40436716 BACKGROUND

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 23, 2026
• Study Start: May 1, 2024
• Primary Completion: September 10, 2025
• Study Completion: May 15, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

IT (1)