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. 2025 Jan 27;17(1):101704.
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  1 , María Del Rocío Francisco  2 , Jose L Vargas Basurto  2 , Kevin D Gonzalez-Gomez  2 , Mercedes Amieva-Balmori  2 , Federico Roesch Dietlen  2 , José M Remes-Troche  2
Affiliations

Effect of alpha-lipoic acid and Silybum marianum supplementation with a Mediterranean diet on metabolic dysfunction-associated steatosis

Ana D Cano Contreras et al. World J Hepatol. .

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

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Flow diagram of the study.
Figure 2
Figure 2
Mean controlled attenuation parameter at baseline and weeks 12 and 24 in the intervention and control groups with metabolic dysfunction-associated steatotic liver disease. P values are from repeated measures analysis of variance. CAP: Controlled attenuation parameter. Group A: Silybum marianum and alpha-lipoic acid + Mediterranean diet; Group B: Placebo + Mediterranean diet.
See this image and copyright information in PMC

References

    1. Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016;64:73–84. - PubMed
    1. Rinella ME, Lazarus JV, Ratziu V, Francque SM, Sanyal AJ, Kanwal F, Romero D, Abdelmalek MF, Anstee QM, Arab JP, Arrese M, Bataller R, Beuers U, Boursier J, Bugianesi E, Byrne CD, Castro Narro GE, Chowdhury A, Cortez-Pinto H, Cryer DR, Cusi K, El-Kassas M, Klein S, Eskridge W, Fan J, Gawrieh S, Guy CD, Harrison SA, Kim SU, Koot BG, Korenjak M, Kowdley KV, Lacaille F, Loomba R, Mitchell-Thain R, Morgan TR, Powell EE, Roden M, Romero-Gómez M, Silva M, Singh SP, Sookoian SC, Spearman CW, Tiniakos D, Valenti L, Vos MB, Wong VW, Xanthakos S, Yilmaz Y, Younossi Z, Hobbs A, Villota-Rivas M, Newsome PN NAFLD Nomenclature consensus group. A multisociety Delphi consensus statement on new fatty liver disease nomenclature. Hepatology. 2023;78:1966–1986. - PMC - PubMed
    1. Houttu V, Csader S, Nieuwdorp M, Holleboom AG, Schwab U. Dietary Interventions in Patients With Non-alcoholic Fatty Liver Disease: A Systematic Review and Meta-Analysis. Front Nutr. 2021;8:716783. - PMC - PubMed
    1. Hohenester S, Christiansen S, Nagel J, Wimmer R, Artmann R, Denk G, Bischoff M, Bischoff G, Rust C. Lifestyle intervention for morbid obesity: effects on liver steatosis, inflammation, and fibrosis. Am J Physiol Gastrointest Liver Physiol. 2018;315:G329–G338. - PubMed
    1. Gillessen A, Schmidt HH. Silymarin as Supportive Treatment in Liver Diseases: A Narrative Review. Adv Ther. 2020;37:1279–1301. - PMC - PubMed

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