The study population comprised 230 newborn infants with at least one family member affected by type 1 diabetes and a predisposing genotype based on screening cord blood at birth. The children were randomized into two groups; the infants in the intervention group were weaned to a highly hydrolyzed casein-based formula while those in the control group were weaned to a regular cow’s milk-based formula.
The intention was that the children should be exposed to their study formula for at least 2 months by the age of 8 months.
They were observed up to the age of 10 years for the appearance of diabetes-predictive autoantibodies and progression to type 1 diabetes.
Twenty-five children developed at least two diabetes-predictive autoantibodies out of the five tested for, which marks a high risk of presenting with clinical diabetes. Seventeen children tested positive for two or more autoantibodies had been randomized to the control group, whereas seven belonged to the intervention group.
Nine children in the control group presented with clinical diabetes by the age of 10 years, while four of those who had been exposed to the casein hydrolysate progressed to clinical disease.
— The study showed that the safe and simple dietary intervention applied in this pilot trial was capable of reducing the emergence of diabetes-predictive autoantibodies by about 50% by age 10 in the participants carrying increased disease risk, states Professor Mikael Knip from the University of Helsinki.
— However, the current study population does not provide sufficient statistical power to definitely conclude whether an intervention of this type will reduce the frequency of clinical type 1 diabetes, although the preliminary data are promising.
A full-scale trial, called TRIGR, is currently running in 77 study centers in 15 countries to provide a conclusive answer to the question of whether weaning to a highly hydrolyzed formula will reduce the cumulative incidence of clinical type 1 diabetes. A total of 2160 children have been randomized for TRIGR. The first end-point in TRIGR will be reached in 2013 and the final endpoint in the year 2017.