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

Study Overview

• Status: Recruiting
• Conditions: Metabolic Associated Fatty Liver Disease
• Intervention / Treatment: Other: Placebo; Dietary supplement: LUDLEV®300 mg/46.2 mg

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ANA D CONTRERAS, MD; Phone Number: 2881011174; Email: anacano_143@hotmail.com

Study Locations

• Mexico
  • Veracruz
    • Mexico, Veracruz, Mexico, 917000
      • Recruiting
      • Ana Delfina Cano Contreras
      • Contact: ANA DELFINA CANO CONTRERAS, MD; Phone Number: 2299318011; Email: anacano_143@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo treatment (maltodextrin), once daily (u.i.d)	Dietary supplement: LUDLEV®300 mg/46.2 mg; LUDLEV®300 mg/46.2 mg once day
Experimental: Alpha-lipoic acid and y silybum marianum; LUDLEV®300 mg/46.2 mg once day	Other: Placebo; Placebo treatment (maltodextrin), once daily (u.i.d)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Transitional elastography with Fibroscan	30 minutes (performed after a 4-hour fast)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
controlled attenuation parameter (CAP)	Hepatic steatosis by controlled attenuation parameter	30 minutes (performed after a 4-hour fast)
kilopascals (kpa)	Hepatic stiffness by Transitional elastography with Fibroscan	30 minutes (performed after a 4-hour fast)

Collaborators and Investigators

• Sponsor: Saluz Investigación S. C.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): January 10, 2024
• Study Completion (Estimated): March 30, 2024

Study Registration Dates

• First Submitted: June 4, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: fatty liver disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: SaluzInvestigacion

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No