Children at risk for type 1 diabetes showed fewer signs of beta-cell autoimmunity for up to 10 years if they were fed a highly hydrolyzed casein formula rather than conventional cow's milk–based formula during infancy.
This indicates that “a preventive dietary intervention aimed at decreasing the risk of type 1 diabetes may be feasible,” said Dr. Mikael Knip of the University of Helsinki, Finland, and his associates.
Their pilot study – the Trial to Reduce IDDM in the Genetically at Risk (TRIGR) – was not sufficiently powered to render a definitive conclusion about preventing progression to overt type 1 diabetes. However, a larger ongoing TRIGR study is now underway in 15 countries and is designed to address that issue, the investigators noted.
The pilot study involved 230 neonates born at 15 Finnish hospitals between 1995 and 1997 whose HLA genotypes showed susceptibility to type 1 diabetes and who had at least one first-degree relative with the disorder. The newborns were randomly assigned in a double-blind fashion to receive for at least 6 months either an extensively hydrolyzed casein-based formula (Nutramigen) or a control cow's milk–based formula made to smell and taste like the intervention formula.
Both formulas were offered only when breast milk was unavailable. Breast-feeding was encouraged, and mothers breast-fed at their own discretion and without modifying their diets.
Blood samples were obtained periodically to test for five autoantibodies.
The intervention formula was linked with a significant decrease in risk of seropositivity for islet-cell antibodies, the tyrosine phosphatase-related insulinoma-associated 2 molecule, or to at least one of the five autoantibodies assessed, which also included insulin antibodies, and antibodies to glutamic acid decarboxylase, and zinc transporter 8, Dr. Knip and his colleagues said (N. Engl. J. Med. 2010;363:1900-8).
By 10 years of age, 6% of children in the intervention group and 8% of those in the control group developed type 1 diabetes. This difference was nonsignificant, but the study was not designed to show significance of this measure, they added.