Using alpha-lipoic acid and silybum marianum to improve 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

This study is testing if a combination of alpha-lipoic acid and silybum marianum can help people with fatty liver disease who are overweight or obese feel better and improve their liver health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Saluz Investigación S. C. (other)
• Locations: 1 site (Mexico, Veracruz)
• Trial ID: NCT05913986 on ClinicalTrials.gov

What this trial studies

This randomized, controlled, double-blind study evaluates the effectiveness of a formulation containing alpha-lipoic acid and silybum marianum compared to a placebo in treating metabolic associated fatty liver disease (MAFLD). The study focuses on patients who are overweight or obese and may also have diabetes, as these conditions are commonly associated with MAFLD. The hypothesis is that the antioxidant properties of alpha-lipoic acid can improve metabolic parameters and liver health in affected individuals. Participants will be monitored for changes in insulin resistance and other metabolic markers during the intervention.

Who should consider this trial

Good fit: Ideal candidates are overweight or obese individuals diagnosed with metabolic associated fatty liver disease, particularly those with diabetes or other metabolic risk factors.

Not a fit: Patients without evidence of hepatic steatosis or those not meeting the metabolic risk criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve liver health and metabolic function in patients with fatty liver disease.

How similar studies have performed: Other studies have shown promising results with similar antioxidant approaches in treating metabolic disorders, suggesting potential for success in this trial.

Eligibility criteria

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.

Where this trial is running

Mexico, Veracruz

• Ana Delfina Cano Contreras — Mexico, Veracruz, Mexico (RECRUITING)

Study contacts

• Study coordinator: ANA D CONTRERAS, MD

Conditions: Metabolic Associated Fatty Liver Disease, fatty liver disease