Infants weaned to hydrolyzed formula may not have a lower risk for type 1 diabetes developing compared with infants weaned to a conventional cow’s milk-based formula, according to a study published in the Journal of the American Medical Association.
Researchers conducted a double-blind randomized clinical trial (ClinicalTrials.gov identifier: NCT00179777) at 78 study centers in 15 different countries. The study included 2159 infants who had a first-degree relative with type 1 diabetes and who also were human leukocyte antigen (HLA)-conferred disease susceptible. Infants were randomly assigned to receive either extensively hydrolyzed casein formula (n=1081) or conventional formula containing cow’s milk protein (n=1078).
The purpose of the study was to determine whether early exposure to conventional formula containing cow’s milk complex dietary proteins increases the risk for type 1 diabetes developing in a child with genetic susceptibility.
Study results demonstrated that the risk for type 1 diabetes developing in infants weaned to hydrolyzed formula was 8.4% and 7.6% for infants weaned to conventional formula (difference 0.8% [95% CI, -1.6-3.2%]. After adjustment for variables such as HLA risk group, breastfeeding duration, formula consumption duration, gender, and geographic region, the hazard ratio was found to be 1.1 (95% CI, 0.8-1.5; P =.46). The median age of onset of type 1 diabetes was also similar between groups at 6.0 [Q1-Q3, 3.1-8.9] and 5.8 [Q1-Q3, 2.6-9.1] years for those infants assigned to casein and conventional formula, respectively, demonstrating a difference of 0.2 [95% CI, -0.9-1.2; P =.75].
The investigators concluded that, “for children with an HLA genotype conferring increased risk for type 1 diabetes and an affected first-degree relative, weaning to a highly hydrolyzed formula during infancy did not reduce the incidence of type 1 diabetes compared with cow’s milk-based formula.”
Therefore, clinicians should not change dietary recommendations to parents of infants identified as at an increased risk for the development of type 1 diabetes.
Writing Group for the TRIGR Study Group, Knip M, Åkerblom HK, Al Taji E, et al. Effect of hydrolyzed infant formula vs conventional formula on risk of type 1 diabetes: the TRIGR randomized clinical trial. JAMA. 2018;319:38-48.