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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
LUDLEV®300 mg/46.2 mg once day
Placebo treatment (maltodextrin), once daily (u.i.d)
Ana Delfina Cano Contreras
Mexico, Veracruz, Mexico
RECRUITINGTransitional elastography with Fibroscan
Time frame: 30 minutes (performed after a 4-hour fast)
controlled attenuation parameter (CAP)
Hepatic steatosis by controlled attenuation parameter
Time frame: 30 minutes (performed after a 4-hour fast)
kilopascals (kpa)
Hepatic stiffness by Transitional elastography with Fibroscan
Time frame: 30 minutes (performed after a 4-hour fast)
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