Effects of a Dairy Product Enriched With Lactoferrin on Iron Status of Women With Gestational Diabetes. A Pilot Randomized Controlled Double-blind Trial

Lactoferrin is recognized as both effective and safe during pregnancy. Nonetheless, studies specifically investigating its effects in women with GDM are limited.

The primary outcome of this pilot RCT was the change in serum ferritin concentration following the consumption of lactoferrin-enriched yogurt compared with non-enriched control yogurt. Secondary outcomes included changes between the two arms in hemoglobin concentration, hematocrit, red blood cell count, serum iron, transferrin levels, total iron-binding capacity, and transferrin saturation. Additional outcomes were the evaluation of variations in metabolic variables, the occurrence of adverse maternal and neonatal outcomes, and changes in the maternal gut microbiota before and after the intervention

The study began on March 1, 2023, and continued until May 31, 2025. All participants with diagnosis of GDM were recruited according to the inclusion criteria.

Participants received the same dietary counseling and nutritional recommendations aligned with current guidelines by trained registered dieticians. Women were randomized to receive the lactoferrin-enriched yogurt (experimental arm, n=25) and the non-enriched control yogurt (control arm, n=25). Both products were derived from high-quality cow's milk, had the same color, flavor, texture, and were contained in identical unlabeled white 125g plastic cups, each identified solely by a code. The experimental product was enriched with lactoferrin during the manufacturing process (100mg/125g).