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

NCT ID: NCT05913986

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-03-30

Brief 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.

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.

Conditions

Metabolic Associated Fatty Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Alpha-lipoic acid and y silybum marianum

LUDLEV®300 mg/46.2 mg once day

Group Type: EXPERIMENTAL

Placebo

Intervention Type: OTHER

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

LUDLEV®300 mg/46.2 mg

Intervention Type: DIETARY_SUPPLEMENT

LUDLEV®300 mg/46.2 mg once day

Interventions

LUDLEV®300 mg/46.2 mg

LUDLEV®300 mg/46.2 mg once day

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saluz Investigación S. C.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ana Delfina Cano Contreras

Mexico, Veracruz, Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

ANA D CONTRERAS, MD

Role: CONTACT

anacano_143@hotmail.com

2881011174

Facility Contacts

ANA DELFINA CANO CONTRERAS, MD

Role: primary

anacano_143@hotmail.com

2299318011

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

SaluzInvestigacion

Identifier Type: -

Identifier Source: org_study_id