Last updated 18 months ago
Supplementation With Alpha-lipoic Acid and Silybum Marianum(LUDLEV®) for the Improvement of Fatty Liver Disease
50 patients around the world
Available in Mexico
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.
Saluz Investigación S. C.
1Research sites
50Patients around the world
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- Subjects treated at the Instituto de Investigaciones Médico Biológicas de la Universidad Veracruzana with a diagnosis of Fatty Liver DiseaseAgree to voluntarily participate in the study and sign informed consent.Patients with evidence of hepatic steatosis who are overweight or obesePatients 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
- Patients meeting diagnostic criteria for Fatty Liver Disease with normal weightPatients with terminal illness, cancer, renal disease in renal replacement therapyPregnant womenPatients with inability to understand or follow the study protocolSensitivity to the components of the formula.
Sites
Ana Delfina Cano Contreras
Recruiting
SponsorSaluz Investigación S. C.
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05913986
