Early feeding and risk of type 1 diabetes: experiences from the Trial to Reduce Insulin-dependent diabetes mellitus in the Genetically at

Short-term breastfeeding and early exposure to complex dietary pro-teins, such as cow milk proteins and cereals, or to fruit, berries, and roots have been implicated as risk factors for b cell autoimmunity, clinical type 1 diabetes, or both. The Trial to Reduce Insulin-de-pendent diabetes mellitus in the Genetically at Risk (TRIGR) is an international, randomized, double-blind, controlled intervention tri-al designed to answer the question of whether weaning to an exten-sively hydrolyzed formula in infancy will decrease the risk of type 1 diabetes later in childhood. In our pilot study, weaning to a highly hydrolyzed formula decreased by ’50 % the cumulative incidence of one or more diabetes-associated autoantibodies by a mean age of 4.7 y. This finding was confirmed in a recent follow-up analysis to 10 y of age. Currently, the full-scale TRIGR takes place in 77 centers in 15 countries. The TRIGR initially recruited 5606 new-born infants with a family member affected by type 1 diabetes and enrolled 2159 eligible subjects who carried a risk-conferring HLA genotype. All recruited mothers were encouraged to breastfeed. The intervention lasted for 6–8 mo with a minimum study formula ex-posure time of 2 mo, and hydrolyzed casein and standard cow milk– based weaning formulas were compared. Eighty percent of the par-ticipants were exposed to the study formula. The overall retention rate over the first 5 y was 87%, and protocol compliance was 94%. The randomization code will be opened when the last recruited child turns 10 y of age (ie, in 2017). Am J Clin Nutr 2011;94 (suppl):1814S–20S