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Effect of Lactoferrin in Obese Children and Adolescents with Metabolic Dysfunction-Associated Steatotic Disease: A Randomized Controlled Study.

  • 2026-03-11
  • Paediatric drugs 28(3)
    • Doaa El Amrousy
    • Dalia El-Afify
    • Esraa Abd Al-Fattah Sorour
    • Shymaa Elrifaey

Study Design

Type
Randomized Controlled Trial (RCT)
Population
73 obese children and adolescents with metabolic dysfunction-associated steatotic liver disease
Methods
Randomized controlled trial, lactoferrin 100 mg once daily for 3 months vs control (no lactoferrin or placebo), both groups on a hypocaloric diet
Blinding
Open-label
Duration
3 months
Funding
Unclear

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 .

Research Insights

  • Lactoferrin→Improved Insulin Sensitivity

    homeostatic model assessment method of insulin resistance (2.86 ± 0.43 vs 3.08 ± 0.4, p = 0.03)

    Effect
    Beneficial
    Effect size
    Small
    Dose
    100 mg once daily for 3 months
  • Lactoferrin→Reduced Body Mass Index

    body mass index (28.7 ± 1.48 vs 30.2 ± 1.45, p < 0.001)

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    100 mg once daily for 3 months
  • Lactoferrin→Reduced Fasting Blood Glucose Levels

    aspartate aminotransferase, fasting blood glucose, total cholesterol, triglycerides, homocysteine, malondialdehyde, and interleukin-6 compared with the control group

    Effect
    Beneficial
    Effect size
    Small
    Dose
    100 mg once daily for 3 months
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