鞣花酸对代谢功能障碍相关脂肪变性肝病（MASLD）患者的影响：一项随机、附加、双盲、对照试验

IF 5.3 2区医学 Q2 IMMUNOLOGY

Inflammopharmacology Pub Date : 2025-09-01 Epub Date: 2025-08-28 DOI:10.1007/s10787-025-01919-3

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

{"title":"鞣花酸对代谢功能障碍相关脂肪变性肝病（MASLD）患者的影响：一项随机、附加、双盲、对照试验","authors":"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","doi":"10.1007/s10787-025-01919-3","DOIUrl":null,"url":null,"abstract":"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).","PeriodicalId":13551,"journal":{"name":"Inflammopharmacology","volume":" ","pages":"5583-5598"},"PeriodicalIF":5.3000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The effects of ellagic acid in metabolic dysfunction-associated steatotic liver disease (MASLD) patients: a randomized, add-on, double-blind, controlled trial.\",\"authors\":\"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\",\"doi\":\"10.1007/s10787-025-01919-3\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"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).\",\"PeriodicalId\":13551,\"journal\":{\"name\":\"Inflammopharmacology\",\"volume\":\" \",\"pages\":\"5583-5598\"},\"PeriodicalIF\":5.3000,\"publicationDate\":\"2025-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Inflammopharmacology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s10787-025-01919-3\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/8/28 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"IMMUNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Inflammopharmacology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s10787-025-01919-3","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/8/28 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"IMMUNOLOGY","Score":null,"Total":0}

引用次数: 0

摘要

背景：代谢功能障碍相关的脂肪变性肝病（MASLD）是一个日益严重的全球性健康问题，目前有效的治疗方法很少。鞣花酸（EA）是一种具有抗氧化和抗炎特性的多酚，可能解决MASLD的多因素发病机制。该试验评估了EA补充与低热量饮食在减少肝脏脂肪和改善代谢和肝功能指标方面的功效。方法：在这项双盲、随机、安慰剂对照的研究中，60名MASLD患者参加了研究。纳入的患者被随机分配每天服用一次200毫克EA或安慰剂，同时进行8周的低热量饮食。主要终点是HRI的绝对平均变化。次要结局包括肝硬度（LS）、肝功能测试、代谢谱、高敏c反应蛋白（hs-CRP）和人体测量指标。结果：与安慰剂组相比，补充EA可显著降低HRI（平均差[MD]: -0.23； P）。结论：补充EA与低热量饮食相结合，可有效降低MASLD患者的肝脏脂肪，改善代谢和肝功能指标。EA是治疗MASLD的一种很有前景的辅助疗法，值得进一步研究。试验注册：该试验已在伊朗临床试验注册中心注册（试验标识符：IRCT20180103038199N16）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

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

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).

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Inflammopharmacology IMMUNOLOGYTOXICOLOGY-TOXICOLOGY

CiteScore

8.00

自引率

3.40%

发文量

200

期刊介绍： Inflammopharmacology is the official publication of the Gastrointestinal Section of the International Union of Basic and Clinical Pharmacology (IUPHAR) and the Hungarian Experimental and Clinical Pharmacology Society (HECPS). Inflammopharmacology publishes papers on all aspects of inflammation and its pharmacological control emphasizing comparisons of (a) different inflammatory states, and (b) the actions, therapeutic efficacy and safety of drugs employed in the treatment of inflammatory conditions. The comparative aspects of the types of inflammatory conditions include gastrointestinal disease (e.g. ulcerative colitis, Crohn''s disease), parasitic diseases, toxicological manifestations of the effects of drugs and environmental agents, arthritic conditions, and inflammatory effects of injury or aging on skeletal muscle. The journal has seven main interest areas: -Drug-Disease Interactions - Conditional Pharmacology - i.e. where the condition (disease or stress state) influences the therapeutic response and side (adverse) effects from anti-inflammatory drugs. Mechanisms of drug-disease and drug disease interactions and the role of different stress states -Rheumatology - particular emphasis on methods of measurement of clinical response effects of new agents, adverse effects from anti-rheumatic drugs -Gastroenterology - with particular emphasis on animal and human models, mechanisms of mucosal inflammation and ulceration and effects of novel and established anti-ulcer, anti-inflammatory agents, or antiparasitic agents -Neuro-Inflammation and Pain - model systems, pharmacology of new analgesic agents and mechanisms of neuro-inflammation and pain -Novel drugs, natural products and nutraceuticals - and their effects on inflammatory processes, especially where there are indications of novel modes action compared with conventional drugs e.g. NSAIDs -Muscle-immune interactions during inflammation [...]