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 .