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

Saluz Investigación S. C.

Status: Enrolling

Conditions: Metabolic Associated Fatty Liver Disease

Treatments: Other: Placebo; Dietary Supplement: LUDLEV®300 mg/46.2 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05913986

SaluzInvestigacion

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects treated at the Instituto de Investigaciones Médico Biológicas de la Universidad Veracruzana with a diagnosis of Fatty Liver Disease
• Agree to voluntarily participate in the study and sign informed consent.
• Patients with evidence of hepatic steatosis who are overweight or obese
• Patients with evidence of hepatic steatosis with diabetes mellitus and overweight or obesity.
• Patients with evidence of steatosis plus metabolic risk abnormalities will be included (waist circumference >102 in men, 88 cm in women, blood pressure >130/85 mmHg or specific treatment, triglycerides >150 mg/dL or specific treatment, HDL cholesterol < 40 mg/dL in men, <50 mg/dL in women or specific treatment, HOMA-IR >2.5, CRP >2 mg/L or prediabetes defined by fasting glucose detection 100 to 125 mg/dL, postload glucose 2 hours 140 to 199 mg/dL or HbA1c between 5.7 to 6.4%)
• Accept not to start any diet program during the study period.
• Agree not to change your current exercise plan during the study period

Exclusion criteria

• Patients meeting diagnostic criteria for Fatty Liver Disease with normal weight
• Patients with terminal illness, cancer, renal disease in renal replacement therapy
• Pregnant women
• Patients with inability to understand or follow the study protocol
• Sensitivity to the components of the formula.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Alpha-lipoic acid and y silybum marianum

Experimental group

Description:

LUDLEV®300 mg/46.2 mg once day

Treatment:

Other: Placebo

Placebo

Placebo Comparator group

Description:

Placebo treatment (maltodextrin), once daily (u.i.d)

Treatment:

Dietary Supplement: LUDLEV®300 mg/46.2 mg