Randomized Controlled Trial
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Hepatol. Jan 27, 2025; 17(1): 101704
Published online Jan 27, 2025. doi: 10.4254/wjh.v17.i1.101704
Effect of alpha-lipoic acid and Silybum marianum supplementation with a Mediterranean diet on metabolic dysfunction-associated steatosis
Ana D Cano Contreras, María Del Rocío Francisco, Jose L Vargas Basurto, Kevin D Gonzalez-Gomez, Mercedes Amieva-Balmori, Federico Roesch Dietlen, José M Remes-Troche
Ana D Cano Contreras, María Del Rocío Francisco, Jose L Vargas Basurto, Kevin D Gonzalez-Gomez, Mercedes Amieva-Balmori, Federico Roesch Dietlen, José M Remes-Troche, Instituto de Investigaciones Médico-Biológicas, Universidad Veracruzana, Veracruz 91700, Mexico
Author contributions: Cano Contreras AD, Francisco MR, and Remes Troche JM contributed to the study concept and design; Vargas Basurto JL, Gonzalez Gomez KD, and Francisco MR coordinated the study; Vargas Basurto JL, K Gonzalez Gomez KD, Francisco MR, and Cano Contreras AD recruited and treated patients; Cano Contreras AD contributed to data analysis and statistics; Cano Contreras AD, Remes Troche JM, and Roesch Dietlen FB drafted the manuscript; All authors contributed to critical revision of the manuscript.
Institutional review board statement: The study received approval from the research committee of the Universidad Veracruzana.
Clinical trial registration statement: The study was registered as a clinical trial, identification number NCT05913986 (ClinicalTrials.gov).
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: Cano Contreras AD is a speaker for Medix and Mayoli, Remes Troche JM is a speaker for Carnot and Alfasigma, and the rest of the authors declare that they have no conflicts of interest.
Data sharing statement: The data supporting the results are not available in a public repository. The information is safeguarded by the principal investigator. If further information is required, the corresponding author should be contacted.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Ana D Cano Contreras, PhD, Professor, Instituto de Investigaciones Médico-Biológicas, Universidad Veracruzana, C. Agustín de Iturbide, Veracruz 91700, Mexico. anacano1403@gmail.com
Received: September 24, 2024
Revised: November 8, 2024
Accepted: December 2, 2024
Published online: January 27, 2025
Processing time: 104 Days and 11.2 Hours
Abstract
BACKGROUND

The treatment of metabolic dysfunction-associated steatotic liver disease (MASLD) has focused on the control of comorbidities. Silybum marianum (SM) and alpha-lipoic acid (ALA) have shown antioxidant and adjuvant effects on the control of metabolic disorders.

AIM

To evaluate whether the SM-ALA formulation (LUDLEV®), in combination with the Mediterranean diet (MD), could improve MASLD-related liver injury.

METHODS

A randomized, double-blind clinical trial was conducted on patients with MASLD. Administration of SM-ALA plus MD (group A) vs placebo plus MD (group B) was compared for 24 weeks. At baseline and weeks 12 and 24, anthropometric measurements, metabolic parameters, and liver function were analyzed. Clinical effectiveness was evaluated through transient elastography.

RESULTS

Fifty patients aged 54 ± 10 years were included, and the majority (74%) were female. Reduced visceral fat and umbilical circumference were reported in both groups, with significance in group A (P = 0.045 and 0.003, respectively). The decrease in controlled attenuation parameter was gradual and maintained at 12 and 24 weeks in group A (P = 0.026), whereas in group B the decrease was greater at week 12 and remained unchanged at week 24 (∆controlled attenuation parameter: -27 dB/m). Mild adverse effects were reported in 4 patients in group A (16%) and 4 patients in group B (16%), with no significant differences between groups (P = 0.641).

CONCLUSION

SM-ALA (LUDLEV®) combined with the MD can promote the improvement of metabolic parameters, reducing visceral fat and hepatic steatosis in Mexican patients with MASLD.

Keywords: Steatotic liver disease; Silybum marianum; Alpha-lipoic acid; Mediterranean diet; Fatty liver

Core Tip: Administration of Silybum marianum and alpha-lipoic acid in conjunction with a Mediterranean-style diet demonstrated a decrease in hepatic steatosis as measured by controlled attenuation parameter, improved biochemical parameters, and a reduction in the percentage of visceral fat. In addition to these metabolic benefits, the combination of Silybum marianum and alpha-lipoic acid is considered safe and well-tolerated.