Effect of alpha-lipoic acid and Silybum marianum supplementation with a Mediterranean diet on metabolic dysfunction-associated steatosis.

Abstract

Background: The treatment of metabolic dysfunction-associated steatotic liver disease (MASLD) has focused on the control of comorbidities. Silybum marianum (SM) and alpha-lipoic acid (ALA) have shown antioxidant and adjuvant effects on the control of metabolic disorders.

Aim: To evaluate whether the SM-ALA formulation (LUDLEV^®), in combination with the Mediterranean diet (MD), could improve MASLD-related liver injury.

Methods: A randomized, double-blind clinical trial was conducted on patients with MASLD. Administration of SM-ALA plus MD (group A) vs placebo plus MD (group B) was compared for 24 weeks. At baseline and weeks 12 and 24, anthropometric measurements, metabolic parameters, and liver function were analyzed. Clinical effectiveness was evaluated through transient elastography.

Results: Fifty patients aged 54 ± 10 years were included, and the majority (74%) were female. Reduced visceral fat and umbilical circumference were reported in both groups, with significance in group A (P = 0.045 and 0.003, respectively). The decrease in controlled attenuation parameter was gradual and maintained at 12 and 24 weeks in group A (P = 0.026), whereas in group B the decrease was greater at week 12 and remained unchanged at week 24 (^∆controlled attenuation parameter: -27 dB/m). Mild adverse effects were reported in 4 patients in group A (16%) and 4 patients in group B (16%), with no significant differences between groups (P = 0.641).

Conclusion: SM-ALA (LUDLEV^®) combined with the MD can promote the improvement of metabolic parameters, reducing visceral fat and hepatic steatosis in Mexican patients with MASLD.