Abstract
The international Trial to Reduce IDDM in the Genetically at Risk (TRIGR) tested the hypothesis whether extensively hydrolyzed casein‐based versus regular cow's milk‐based infant formula reduces the risk of type 1 diabetes. We describe dietary compliance in the trial in terms of study formula intake, feeding of nonrecommended foods, and serum cow's milk antibody concentration reflecting intake of cow's milk protein among 2,159 eligible newborn infants with a biological first‐degree relative affected by type 1 diabetes and with HLA‐conferred susceptibility to type 1 diabetes. The participating infants were introduced to the study formula feeding at the median age of 15 days with a median duration of study formula use of 63 days. During the intervention, 80% of the infants received study formula. Of these, 57% received study formula for at least 2 months. On average, 45.5 l of study formula were used per infant. Only 13% of the population had received a nonrecommended food by the age of 6 months. The dietary compliance was similar in the intervention and control arm. The reported cow's milk consumption by the families matched very well with measured serum casein IgA and IgG antibody concentration. To conclude, good compliance was observed in this randomized infant feeding trial. Compliance varied between the regions and those infants who were breastfed for a longer period of time had a shorter exposure to the study formula. High dietary compliance in infant feeding trial is necessary to allow accurate interpretation of study results.
Highlights
Type 1 diabetes is one of the most common chronic diseases of childhood with an increasing incidence around the world (Patterson et al, 2019)
The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) study reported that the cumulative incidence of diabetes- associated autoantibodies and type 1 diabetes in children with a first-degree relative with type 1 diabetes and a risk-associated Human leukocyte antigen (HLA) genotype did not differ in children weaned to an extensively hydrolyzed casein formula and one containing intact cow's milk proteins (Writing Group for the TRIGR Study Group et al, 2018)
TRIGR is a randomized controlled trial launched to determine whether weaning to extensively hydrolyzed infant formula compared to one containing intact cow's milk proteins given during the first 6–8 months of life would prevent type 1 diabetes in genetically susceptible children (Knip et al, 2014; TRIGR Study Group, 2007; Åkerblom et al, 2011; Writing Group for the TRIGR Study Group et al, 2018)
Summary
Type 1 diabetes is one of the most common chronic diseases of childhood with an increasing incidence around the world (Patterson et al, 2019). TRIGR is a randomized controlled trial launched to determine whether weaning to extensively hydrolyzed infant formula compared to one containing intact cow's milk proteins given during the first 6–8 months of life would prevent type 1 diabetes in genetically susceptible children (Knip et al, 2014; TRIGR Study Group, 2007; Åkerblom et al, 2011; Writing Group for the TRIGR Study Group et al, 2018). It is the first nutritional full-scale randomized trial for. The study was approved by the ethics committees of all participating centers and was conducted according to the standards of the Declaration of Helsinki and conforms to Directive 2010/63/EU
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