In a follow up of 1744 new-born infants the absolute risk of type 1 diabetes was 8.4% among the 91 babies randomised to the casein hydrolysate compared to 7.6% of those randomised to conventional formula.
“In 2002, we embarked on a large-scale study on infants with a family member affected by type 1 diabetes and with genetic risk for type 1 diabetes to find an answer to the question whether delaying the exposure to complex foreign proteins will decrease the risk of diabetes”, said the University of Helsinki’s professor Mikael Knip, the TRIGR Study leader.
“There is no evidence to revise the current dietary recommendations for infants at high risk for type 1 diabetes.”
The association’s history
The TRIGR study has a study history that stretches back to the mid-80’s. Here, breastfeeding was associated with lower rates of children developing type 1 diabetes.
More recently, research has centred on hydrolysed formulas that contain cow’s milk proteins split into small peptides.
Popular brands that use these protein forms include Aptamil’s Pepti, Cow & Gate Pepti-junior, SHS Nutricia Pepdite, MCT and SHS Nutricia Infatrini Peptisorb and Mead Johnson’s Nutramigen and Pregestimil.
Investigations into this method of protein preparation found decreased rates of type 1 diabetes development in animals weaned to hydrolysed proteins over intact foreign proteins.
An earlier trial by Dr Knip pointed to a similar relationship in humans, where the immune system in young infants with genetic diabetes risk appeared less able to handle intact foreign food proteins.
Dr Knip’s latest investigation took breastfed infants, who were then either weaned on extensively hydrolysed casein formula or a formula that used intact cow’s milk proteins.
These subjects were feed on either formula for a minimum of two months until they were 6-8 months old. Parents were asked not to feed their infant cow´s milk proteins from other food sources.
All infants were then monitored for a minimum of ten years, where those that developed diabetes were noted.
The findings seem to raise more questions than answers as the team pointed to an outcome that was consistent with a report that showed no difference between the study groups in the appearance of islet autoantibodies.
“However, it is not consistent with data from the pilot study, which reported that weaning to an extensively hydrolysed formula in infancy was associated with a decrease in the frequency of disease-associated autoantibodies by the age of 7.5 years,” they added.
The team were quick to acknowledge the findings could not be taken as advice applicable to the general population.
“Participants were selected based on a positive family history for type 1 diabetes and an HLA genotype conferring risk for type 1 diabetes,” the team explained.
“In addition, the outcome is not necessarily applicable to children with other HLA genotypes.”
Published online ahead of print: doi:10.1001/jama.2017.19826
“Effect of Hydrolyzed Infant Formula vs Conventional Formula on Risk of Type 1 Diabetes.”
Authors: Mikael Knip et al.