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

Metabolic Associated Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05913986
• Other study ID #: SaluzInvestigacion
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: June 2023
• Source: Saluz Investigación S. C.
• Contact: ANA D CONTRERAS, MD
• Phone: 2881011174
• Email: anacano_143[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 30, 2024
• Est. primary completion date: January 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Metabolic Associated Fatty Liver Disease
• Non-alcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• LUDLEV®300 mg/46.2 mg
LUDLEV®300 mg/46.2 mg once day

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

Locations

Country	Name	City	State
Mexico	Ana Delfina Cano Contreras	Mexico	Veracruz

Sponsors (1)

Lead Sponsor	Collaborator
Saluz Investigación S. C.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transitional elastography with Fibroscan		30 minutes (performed after a 4-hour fast)
Secondary	controlled attenuation parameter (CAP)	Hepatic steatosis by controlled attenuation parameter	30 minutes (performed after a 4-hour fast)
Secondary	kilopascals (kpa)	Hepatic stiffness by Transitional elastography with Fibroscan	30 minutes (performed after a 4-hour fast)