Doaa El Amrousy, Dalia El-Afify, Esraa Abd Al-Fattah Sorour, Shymaa Elrifaey
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Both groups were on a hypocaloric diet. Measurements of weight, body mass index, alanine aminotransferase, aspartate aminotransferase, fasting blood glucose, fasting insulin, homeostatic model assessment method of insulin resistance, lipid profile, homocysteine, malondialdehyde, interleukin-6, and interleukin-10 were assessed at baseline and after 3 months of treatment.</p><p><strong>Results: </strong>Seventy patients completed the study. After 3 months of treatment, the lactoferrin group had a significantly lower weight, body mass index (28.7 ± 1.48 vs 30.2 ± 1.45, p < 0.001), alanine aminotransferase (47.7 ± 4.4 vs 56.4 ± 4.3, p < 0.001), homeostatic model assessment method of insulin resistance (2.86 ± 0.43 vs 3.08 ± 0.4, p = 0.03), aspartate aminotransferase, fasting blood glucose, total cholesterol, triglycerides, homocysteine, malondialdehyde, and interleukin-6 compared with the control group and the pre-treatment levels.</p><p><strong>Conclusions: </strong>Lactoferrin may help in weight reduction, improve insulin resistance and lipid profile, and decrease oxidative stress and inflammation in obese children and adolescents with metabolic dysfunction-associated steatotic liver disease.</p><p><strong>Clinical trial registration: </strong>The clinical trial was registered at Pan African Clinical Trial Registry with ID: PACTR202302847529384,T https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=24309 .</p>","PeriodicalId":19955,"journal":{"name":"Pediatric Drugs","volume":" ","pages":"285-294"},"PeriodicalIF":3.3000,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13121533/pdf/","citationCount":"0","resultStr":"{\"title\":\"Effect of Lactoferrin in Obese Children and Adolescents with Metabolic Dysfunction-Associated Steatotic Disease: A Randomized Controlled Study.\",\"authors\":\"Doaa El Amrousy, Dalia El-Afify, Esraa Abd Al-Fattah Sorour, Shymaa Elrifaey\",\"doi\":\"10.1007/s40272-026-00742-9\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background and objective: </strong>Lactoferrin is an iron-binding glycoprotein existing in mammalian milk. It has immunomodulatory, antioxidant, and anti-inflammatory properties, and it can also regulate metabolism. The present study investigated the effect of lactoferrin in obese children and adolescents with metabolic dysfunction-associated steatotic liver disease.</p><p><strong>Methods: </strong>This randomized controlled trial was performed on 73 obese children and adolescents with metabolic dysfunction-associated steatotic liver disease. The patients were randomized into two groups: group I, who received lactoferrin 100 mg once daily for 3 months, and group II, who did not receive lactoferrin or placebo as the control group. Both groups were on a hypocaloric diet. 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引用次数: 0
摘要
背景与目的:乳铁蛋白是存在于哺乳动物乳汁中的一种铁结合糖蛋白。它具有免疫调节、抗氧化和抗炎的特性,还可以调节新陈代谢。本研究探讨了乳铁蛋白在肥胖儿童和青少年代谢功能障碍相关脂肪变性肝病中的作用。方法:这项随机对照试验对73名患有代谢功能障碍相关脂肪变性肝病的肥胖儿童和青少年进行了研究。患者被随机分为两组:第一组,接受乳铁蛋白100mg,每日一次,持续3个月;第二组,不接受乳铁蛋白或安慰剂作为对照组。两组都采用低热量饮食。在基线和治疗3个月后测量体重、体重指数、丙氨酸转氨酶、天冬氨酸转氨酶、空腹血糖、空腹胰岛素、胰岛素抵抗的稳态模型评估方法、血脂、同型半胱氨酸、丙二醛、白细胞介素-6和白细胞介素-10。结果:70例患者完成了研究。3个月的治疗后,乳铁蛋白组显著降低体重、身体质量指数(28.7±1.48 vs 30.2±1.45,p < 0.001),丙氨酸转氨酶(47.7±4.4 vs 56.4±4.3,p < 0.001),稳态模型评估胰岛素抵抗的方法(2.86±0.43 vs 3.08±0.4,p = 0.03),天冬氨酸转氨酶、空腹血糖、总胆固醇、甘油三酯、同型半胱氨酸,丙二醛,和白细胞介素- 6与对照组相比,预处理的水平。结论:乳铁蛋白可能有助于体重减轻,改善胰岛素抵抗和脂质特征,并减少氧化应激和炎症与代谢功能障碍相关的肥胖儿童和青少年脂肪肝疾病。临床试验注册:该临床试验在Pan African Clinical trial Registry注册,ID: PACTR202302847529384,T https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=24309。
Effect of Lactoferrin in Obese Children and Adolescents with Metabolic Dysfunction-Associated Steatotic Disease: A Randomized Controlled Study.
Background and objective: Lactoferrin is an iron-binding glycoprotein existing in mammalian milk. It has immunomodulatory, antioxidant, and anti-inflammatory properties, and it can also regulate metabolism. The present study investigated the effect of lactoferrin in obese children and adolescents with metabolic dysfunction-associated steatotic liver disease.
Methods: This randomized controlled trial was performed on 73 obese children and adolescents with metabolic dysfunction-associated steatotic liver disease. The patients were randomized into two groups: group I, who received lactoferrin 100 mg once daily for 3 months, and group II, who did not receive lactoferrin or placebo as the control group. Both groups were on a hypocaloric diet. Measurements of weight, body mass index, alanine aminotransferase, aspartate aminotransferase, fasting blood glucose, fasting insulin, homeostatic model assessment method of insulin resistance, lipid profile, homocysteine, malondialdehyde, interleukin-6, and interleukin-10 were assessed at baseline and after 3 months of treatment.
Results: Seventy patients completed the study. After 3 months of treatment, the lactoferrin group had a significantly lower weight, body mass index (28.7 ± 1.48 vs 30.2 ± 1.45, p < 0.001), alanine aminotransferase (47.7 ± 4.4 vs 56.4 ± 4.3, p < 0.001), homeostatic model assessment method of insulin resistance (2.86 ± 0.43 vs 3.08 ± 0.4, p = 0.03), aspartate aminotransferase, fasting blood glucose, total cholesterol, triglycerides, homocysteine, malondialdehyde, and interleukin-6 compared with the control group and the pre-treatment levels.
Conclusions: Lactoferrin may help in weight reduction, improve insulin resistance and lipid profile, and decrease oxidative stress and inflammation in obese children and adolescents with metabolic dysfunction-associated steatotic liver disease.
Clinical trial registration: The clinical trial was registered at Pan African Clinical Trial Registry with ID: PACTR202302847529384,T https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=24309 .
期刊介绍:
Pediatric Drugs promotes the optimization and advancement of all aspects of pharmacotherapy for healthcare professionals interested in pediatric drug therapy (including vaccines). The program of review and original research articles provides healthcare decision makers with clinically applicable knowledge on issues relevant to drug therapy in all areas of neonatology and the care of children and adolescents. The Journal includes:
-overviews of contentious or emerging issues.
-comprehensive narrative reviews of topics relating to the effective and safe management of drug therapy through all stages of pediatric development.
-practical reviews covering optimum drug management of specific clinical situations.
-systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement.
-Adis Drug Reviews of the properties and place in therapy of both newer and established drugs in the pediatric population.
-original research articles reporting the results of well-designed studies with a strong link to clinical practice, such as clinical pharmacodynamic and pharmacokinetic studies, clinical trials, meta-analyses, outcomes research, and pharmacoeconomic and pharmacoepidemiological studies.
Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Pediatric Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.