Previous studies suggested a baby formula lacking complex cow milk proteins might prevent the development of auto-antibodies - which signify inflammatory changes in an organ - thus preventing type 1 diabetes. However, a large international study shows that infants at risk for the disease who were fed the special formula still produced antibodies against the insulin-producing cells of the pancreas.
Though the researchers, from Children's Hospital of Pittsburgh of the University of Pittsburgh School of Medicine, had hoped they could try to prevent type 1 diabetes, they do note that their findings do not mean the children will definitely develop type 1 diabetes.
They publish their findings in the JAMA.
Earlier studies have indicated that early exposure to complex foreign proteins - such as those in cow's milk - increase risk of type 1 diabetes in individuals who are predisposed to the disease. But hydrolyzed formulas, where the proteins are split, do not contain intact proteins.
For this reason, the research team wanted to test whether weaning to such a formula could decrease the incidence of auto-antibodies associated with diabetes in young children.
When a person has type 1 diabetes, their immune system attacks its own pancreatic beta cells, which are the cells that make insulin to regulate blood sugar levels. And this process starts very early in life.
According to the Centers for Disease Control and Prevention (CDC), more than 13,000 young people in the US are diagnosed with type 1 diabetes each year.
In order to study the effects of hydrolyzed baby formula, from 2002-2007 at 78 sites in 15 countries, the research group from the "Trial to Reduce IDDM in the Genetically at Risk" (TRIGR) randomly assigned 1,078 high-risk infants to be weaned to a hydrolyzed formula and 1,081 high-risk infants to be weaned on conventional formula - made with 80% cow milk proteins and 20% hydrolyzed casein protein.
Jury still out: research to be concluded in 2017
Babies who were fed a hydrolyzed formula did not show a difference in antibody levels from the babies who were fed conventional formula.
Because the two formulas were so similar in taste and smell, neither the parents nor the researchers were able to tell the difference between them.
The parents of each baby made their own decisions about breastfeeding and when to wean the baby to formula.
Blood samples taken from the umbilical cord after birth and at ages 3, 6, 9, 12, 18 and 24 months of age were tested for antibody levels. Additionally, every year after that up to the age of 10, the children were tested.
Results showed that, after 7 years' average follow-up, the researchers observed no differences in antibody levels between the two groups.
Commenting on the findings, principal investigator Dorothy Becker, professor of pediatrics at Children's Hospital of Pittsburgh, says:
"This tells us that the kind of formula the baby drinks doesn't affect the inflammatory changes going on in the pancreas. But it doesn't tell us yet whether they will develop diabetes.
In one animal study, mice that were fed the experimental formula had the inflammatory markers, but diabetes was almost totally prevented using the same experimental formula. That could be the case with these children, too."
She adds that their trial concludes in February 2017, when all participating children will be at least 10 years old, so "we should have enough evidence to say whether or not this experimental formula can prevent them from getting type 1 diabetes."
Medical News Today recently reported on another study published in JAMA, which showed that both type 1 and type 2 diabetes are on the rise in American youths.