NCT07724067Completed
GLUT-F Improves MASLD Liver Function
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
Source: ClinicalTrials.gov · Last updated 23 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 42 (actual)
- First submitted
- 14 Jul 2026
- Start date
- 1 May 2024
- Primary completion date
- 10 Sept 2025
- Lead sponsor
- University of Bari
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07724067
What you commit to
- Study type: Interventional
- Participants enrolled: 42
- From 1 May 2024 to the primary completion date, 10 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- 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
Other
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Bari Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.