Supplementation With Alpha-lipoic Acid and Silybum Marianum(LUDLEV®) for the Improvement of Fatty Liver Disease
Metabolic Associated Fatty Liver Disease
About this trial
This is an interventional treatment trial for Metabolic Associated Fatty Liver Disease focused on measuring fatty liver disease
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.
Sites / Locations
- Ana Delfina Cano ContrerasRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Alpha-lipoic acid and y silybum marianum
Placebo
LUDLEV®300 mg/46.2 mg once day
Placebo treatment (maltodextrin), once daily (u.i.d)