medwireNews: Limiting the exposure of high-risk infants to foreign intact protein does not reduce their risk for developing type 1 diabetes, show the results of the TRIGR study.
Infants in TRIGR (Trial to Reduce Insulin-Dependent Diabetes Mellitus in the Genetically at Risk) were randomly assigned to receive either an extensively hydrolyzed casein-based formula or a control formula of 80% intact cow’s milk protein and 20% hydrolyzed milk protein, although breastfeeding was also encouraged for all participants.
As reported in JAMA, around 80% of both groups were exposed to the study formula milks, but this did not influence their risk for diabetes, which occurred in 8.4% of 1081 infants in the hydrolyzed casein formula group and 7.6% of 1078 in the control group.
The difference remained nonsignificant after adjusting for variables including sex, duration of breastfeeding, and human leukocyte antigen (HLA) risk group. And there was also no difference in a per protocol analysis of 1177 infants who were exposed to the study formula milks for at least 60 days – before the age of 6 months or before 8 months if this was not achieved – and were not exposed to any non-permitted cow’s milk products.
The current findings are in line with the previously reported islet autoantibody results for TRIGR participants, which were similar in the two groups, contrary to the autoantibody results of the pilot study, in 230 infants from Finland, which indicated a protective effect of hydrolyzed formula.
“The larger number of participants in this study provides substantially greater statistical power in a more heterogeneous study population compared with the pilot study and, therefore, provides a more definitive answer to whether weaning to an extensively hydrolyzed formula is protective of diabetes,” say Mikael Knip (University of Helsinki, Finland) and co-researchers.
TRIGR participants were recruited from 15 countries and had genetic susceptibility to diabetes based on their HLA genotypes and a first-degree relative with type 1 diabetes. Those who developed diabetes did so at an average age of 4.1 and 3.9 years in the hydrolyzed and control formula groups, respectively, having developed autoantibodies at 1.6 and 1.5 years.
medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group