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Background <p>With few effective therapies, metabolic dysfunction-associated steatotic liver disease (MASLD) is a rising worldwide health problem. Ellagic acid (EA), a polyphenol with antioxidant and anti-inflammatory properties, may address the multifactorial pathogenesis of MASLD. This trial evaluated the efficacy of EA supplementation combined with a hypocaloric diet in reducing hepatic fat and improving metabolic and liver function markers.</p> Methods <p>In this double-blind, randomized, placebo-controlled study, 60 persons with MASLD participated. Included patients were randomly assigned to consume either 200 mg of EA once a day or a placebo, alongside a hypocaloric diet for 8&#xa0;weeks. The primary outcome was the absolute mean change in HRI. Secondary outcomes included liver stiffness (LS), liver function tests, metabolic profile, high-sensitivity C-reactive protein (hs-CRP), and anthropometric indices.</p> Results <p>EA supplementation significantly reduced HRI compared to the placebo group (mean difference [MD]: -0.23; <i>P</i> &lt; 0.001). Improvements were also observed in LS (MD: −&#xa0;0.47&#xa0;kPa; <i>P</i> &lt; 0.001), alanine transaminase (MD: −&#xa0;27.89&#xa0;U/L; <i>P</i> &lt; 0.001), aspartate transaminase (MD: −&#xa0;8.20&#xa0;U/L; <i>P</i> &lt; 0.001), fasting blood sugar (MD: −&#xa0;6.78&#xa0;mg/dL; <i>P</i> &lt; 0.001), triglyceride (MD: −&#xa0;42.65&#xa0;mg/dL; <i>P</i> = 0.004), low-density lipoprotein cholesterol (MD: −&#xa0;14.63&#xa0;mg/dL; <i>P</i> = 0.026), high-density lipoprotein cholesterol (MD: + 3.38&#xa0;mg/dL; <i>P</i> = 0.019), and hs-CRP (MD: −&#xa0;0.81&#xa0;mg/L; <i>P</i> &lt; 0.001). Anthropometric indices improved significantly by week 8.</p> Conclusions <p>EA supplementation, combined with a hypocaloric diet, effectively reduced hepatic fat and improved metabolic and liver function markers in patients with MASLD. EA represents a promising adjunct therapy for MASLD management, warranting further investigation.</p> Trial registration <p>The trial was registered in the Iranian Registry of Clinical Trials (Trial identifier: IRCT20180103038199N16).</p> Graphical abstract <p></p>

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The effects of ellagic acid in metabolic dysfunction-associated steatotic liver disease (MASLD) patients: a randomized, add-on, double-blind, controlled trial

  • 期刊论文

  • 发表日期：

    2025年8月28日

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  • Mohammad Mahmoudi Azar,
  • Matin Shirazinia,
  • Mohsen Nematy,
  • Vafa Baradaran Rahimi,
  • Motahare Bateni,
  • Fateme Tafaghodi Piadeh Gheibi,
  • Farnood Rajabzadeh,
  • Ladan Goshayeshi,
  • Sara Honari,
  • Mehran Mottahedi,
  • Vahid Reza Askari

摘要

Background

With few effective therapies, metabolic dysfunction-associated steatotic liver disease (MASLD) is a rising worldwide health problem. Ellagic acid (EA), a polyphenol with antioxidant and anti-inflammatory properties, may address the multifactorial pathogenesis of MASLD. This trial evaluated the efficacy of EA supplementation combined with a hypocaloric diet in reducing hepatic fat and improving metabolic and liver function markers.

Methods

In this double-blind, randomized, placebo-controlled study, 60 persons with MASLD participated. Included patients were randomly assigned to consume either 200 mg of EA once a day or a placebo, alongside a hypocaloric diet for 8 weeks. The primary outcome was the absolute mean change in HRI. Secondary outcomes included liver stiffness (LS), liver function tests, metabolic profile, high-sensitivity C-reactive protein (hs-CRP), and anthropometric indices.

Results

EA supplementation significantly reduced HRI compared to the placebo group (mean difference [MD]: -0.23; P < 0.001). Improvements were also observed in LS (MD: − 0.47 kPa; P < 0.001), alanine transaminase (MD: − 27.89 U/L; P < 0.001), aspartate transaminase (MD: − 8.20 U/L; P < 0.001), fasting blood sugar (MD: − 6.78 mg/dL; P < 0.001), triglyceride (MD: − 42.65 mg/dL; P = 0.004), low-density lipoprotein cholesterol (MD: − 14.63 mg/dL; P = 0.026), high-density lipoprotein cholesterol (MD: + 3.38 mg/dL; P = 0.019), and hs-CRP (MD: − 0.81 mg/L; P < 0.001). Anthropometric indices improved significantly by week 8.

Conclusions

EA supplementation, combined with a hypocaloric diet, effectively reduced hepatic fat and improved metabolic and liver function markers in patients with MASLD. EA represents a promising adjunct therapy for MASLD management, warranting further investigation.

Trial registration

The trial was registered in the Iranian Registry of Clinical Trials (Trial identifier: IRCT20180103038199N16).

Graphical abstract