TRIGR, supported by the NICHD Endocrinology, Nutrition, and Growth Branch is a randomized, controlled clinical trial designed to ascertain if the onset of type 1 diabetes mellitus (T1DM) can be delayed or prevented by weaning genetically susceptible infants to Nutramigen®, a hydrolysate of cow milk protein, instead of to a standard cow milk-based infant formula.  The rationale for this intervention comes from studies in which hydrolyzed protein diets prevented the onset of T1DM in animal models.  TRIGR is enrolling 2,032 genetically susceptible infants at 73 sites in 15 countries.  The primary outcome will be the prevalence of T1DM in each of the two groups in 2011.  Interim analyses, planned for 2005 and 2008, will examine autoantibodies directed against islet-cell antigens in the two groups.

Although the NICHD is the lead Institute for TRIGR, funding for this large trial comes from eight other sources, which greatly leverage the NICHD’s contribution.  For instance, the Mead Johnson Company is contributing all of the formula for the trial and has prepared package inserts in 12 languages.  This trial is the first large effort designed to ascertain if a simple nutritional intervention during infancy can delay or prevent the onset of T1DM in children at high genetic risk for the disease.  If the intervention succeeds, the public health implications will be great.

For more information, visit http://trigr.epi.usf.edu/index.html.