Effects of an innovative dairy product enriched with bioactive compounds derived from milk on the health status of patients with gestational diabetes. A pilot randomized controlled double-blind trial

Background: Gestational diabetes Mellitus (GDM) is a form of glucose intolerance first diagnosed during pregnancy, caused by reduced insulin sensitivity and inadequate insulin production. The management of GDM requires a multidisciplinary approach involving obstetricians, endocrinologists, and dietitians; the strategy includes lifestyle interventions and, when necessary, pharmacological treatment. In addition to conventional management strategies, emerging treatments are being explored to further support maternal health during pregnancy, such as the use of lactoferrin. Lactoferrin is a multifunctional glycoprotein belonging to the transferrin family, characterized by its ability to reversibly bind iron ions with high affinity. Although lactoferrin has demonstrated several benefits during pregnancy, to the best of my knowledge, no previous studies have examined its supplementation in pregnancies affected by gestational diabetes mellitus, and none have investigated its effects when incorporated in a food matrix. Methods: A randomized, double-blind, controlled trial was conducted to evaluate the effects of a lactoferrin-enriched yogurt on metabolic variables and iron status in women diagnosed with GDM. Eighty participants were randomized to receive either a lactoferrin-enriched yogurt (100 mg/125g) or a control yogurt without lactoferrin, twice daily for two months. Women with GDM were recruited from the diabetes Clinics of the Sant’Anna Obstetrics and Gynecology Hospital and Mauriziano Umberto I Hospital in Torino, following the inclusion criteria such as gestational age between 24 and 31 weeks and a body Mass Index between 22.5 and 35 kg/m. Assessments were conducted at baseline and at the study end, including anthropometrics, dietary habits, blood parameters (glucose, insulin, ferritin, transferrin, iron, complete blood count), quality of life, and palatability. The study protocol was approved by the Ethics Committee of the “Città della Salute e della Scienza” hospital of Torino. The study is currently ongoing. The blinding process has not been unmasked, and treatment assignments are still concealed from participants and the research team. Results: At present, 47 women were enrolled, 37 completed the intervention, randomized into 19 group A and 18 group B. Both groups showed a significant increase in transferrin levels (Group A 4.38±0.60; Group B 4.17±0.58; p=0.41). A statistically significant between-group difference was observed in ferritin levels, which decreased only in group B (Group A 17.2±10.9; Group B 16.7±7.5; p=0.016). Fasting insulin levels increased significantly within group A (17.3±11.4), but no significant changes in glucose levels or HOMA-IR were detected between groups. The yogurt was well tolerated. The overall palatability rating resulted in an average score of 7,4±2.1, corresponding to "moderately liked" with no significant differences between groups. Conclusion: In conclusion this study represents an innovative approach to integrating lactoferrin into a food to support the management of gestational diabetes mellitus. Given the lack of adverse effects and good palatability, lactoferrin-enriched yogurt may represent a promising dietary intervention for the management of GDM.