NCT05913986

Supplementation With Alpha-lipoic Acid and Silybum Marianum(LUDLEV®) for the Improvement of Fatty Liver Disease

Effect of Supplementation With Alpha-lipoic Acid and Silybum Marianum (LUDLEV®) in Association With a Mediterranean Diet for the Improvement of Metabolic Dysfunction-associated Fatty Liver Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Saluz Investigación S. C. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This randomized, controlled, double-blind study evaluates the utility of alpha-lipoic acid and silybum marianum , versus placebo, in the treatment of metabolic associated fatty liver disease.

Detailed description

Between 80-90% of people with associated metabolic fatty liver disease present with obesity and diabetes mellitus. Alpha-lipoic acid is a cofactor of mitochondrial enzymes that has been considered an antioxidant since its reduced form, dihydrolipoate, reacts with reactive oxygen species and thus protects the cell membrane. Alpha-lipoic acid administration has been shown to have beneficial effects on adipokine levels and metabolic disorders such as diabetes and obesity, both of which are present in patients with MAFLD. It has been shown that the administration of 1200 mg of alpha-lipoic acid in patients with fatty liver decreases insulin resistance, serum leptin, increases the concentration of adiponectin. Given the metabolic effects of alpha-lipoic acid, it is hypothesized that administration of this formulation may be beneficial for people with metabolic associated fatty liver disease.

Conditions

• Metabolic Associated Fatty Liver Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	LUDLEV®300 mg/46.2 mg	LUDLEV®300 mg/46.2 mg once day
OTHER	Placebo	Placebo treatment (maltodextrin), once daily (u.i.d)

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-01-10
• Completion: 2024-03-30
• First posted: 2023-06-22
• Last updated: 2023-06-22

Locations

1 site across 1 country: Mexico