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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Liver steatosis grade
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Liver steatosis grade
时间窗: 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.
次要结局
- 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))
研究者
piero portincasa
Full Professor
University of Bari