Participating in this study may put your infant at increased risk for Type 1 diabetes


Issued by INFACT Canada June 20, 2002



A research project – TRIGR - Trial to Reduce Insulin-Dependent Diabetes in the Genetically at Risk – is one of the largest paediatric trials in the world. This randomized controlled trial will determine if a delay of dietary exposure to intact foreign food proteins can reduce the risk of developing Type 1 diabetes in children genetically predisposed to the disease. The purpose is to test the outcomes for Type 1 diabetes when infants are fed an infant formula with partially hydrolyzed cow’s milk proteins or to a routine infant formula mixture with 30% partially hydrolyzed cow’s milk protein.


The study subjects will be asked to wean their baby from breastmilk to a formula that will have reduced level of intact cow’s milk proteins, or a higher level of intact cow’s milk proteins. As this is a randomized study, they will not know which formula their infant is receiving. There are a number of reasons why one should not participate in this study.






  1. Research has shown that the best way to reduce your infant’s risk of Type I diabetes is by exclusive breastfeeding. The World Health Organization has determined the duration of exclusive breastfeeding to be six months with the introduction of complementary foods to start at six months and continued breastfeeding to two years and beyond to confer optimal growth, development and disease prevention.


  1. The American Academy of Pediatrics’ statement on Breastfeeding and the Use of Human Milk, recommends that families with a history of diabetes breastfeed their children. 

“Research in the United States, Canada, Europe, and other developed countries, among predominantly middle-class populations, provides strong evidence that human milk feeding decreases the incidence and/or severity of diarrhea,1-5 lower respiratory infection,6-9 otitis media,3,10-14 bacteremia,15,16 bacterial meningitis,15,17 botulism,18 urinary tract infection,19 and necrotizing enterocolitis.20,21 There are a number of studies that show a possible protective effect of human milk feeding against sudden infant death syndrome,22-24 insulin-dependent diabetes mellitus,25-27 Crohn's disease,28,29 ulcerative colitis,29 lymphoma,30,31 allergic diseases,32-34 and other chronic digestive diseases.35-37 Breastfeeding has also been related to possible enhancement of cognitive development.38,39”

25.Mayer EJ, Hamman RF, Gay EC, et al. Reduced risk of IDDM among breast-fed children. Diabetes. 1988;37:1625-1632

26.Virtanen SM, Rasanen L, Aro A, et al. Infant feeding in Finnish children <7 yr of age with newly diagnosed IDDM. Diabetes Care. 1991;14:415-417

27.Gerstein HC. Cow's milk exposure and type 1 diabetes mellitus. Diabetes Care. 1994;17:13-19


  1. If you feel you are unable to provide your own breastmilk for your baby, then you should contact a breastfeeding support clinic. (Contact your local hospital or health clinic for a referral.) It is unlikely that there are any medical reasons to prevent you from breastfeeding.

If you still feel you are unable to breastfeed, and you do not want to increase the risk for diabetes for your infant, then the next best option for your baby is to receive pasteurized human milk from Canada’s human milk bank located in Vancouver.  You may be required to pay the cost of transportation for the milk. The milk bank’s address is:

Children’s and Women’s Health Centre

4480 Oak Street, Vancouver BC, V6H 3V4

Telephone: (604) 875-2282

Mother's Milk Bank
Children’s  and Women’s Lactation Services
Vancouver, BC
(604) 875-2282


  1. A number of recent studies (the following abstracts are from PubMed) indicate that there is an increased risk of developing Type 1 diabetes when infants are not breastfed or breastfed for a short time with early introduction of cow’s based infant formulas.



Bovine beta-casein antibodies in breast- and bottle-fed infants: their relevance in Type 1 diabetes.

Monetini L, Cavallo MG, Stefanini L, Ferrazzoli F, Bizzarri C, Marietti G, Curro V, Cervoni M, Pozzilli P; IMDIAB Group.

University of
Rome Tor Vergata, Rome, Italy.

BACKGROUND: Bovine beta-casein is a cow's milk protein that targets both humoral and cellular immune responses in patients with Type 1 diabetes and, to a lesser degree, also in normal subjects. In this study we aimed to determine whether the avoidance of cow's milk consumption early in life could prevent the development of antibody response to bovine beta-casein despite the mother being exposed on a daily basis to cow's milk consumption. MATERIALS AND METHODS: We measured the antibody response to bovine beta-casein using an ELISA method in 28 healthy infants under 4 months of age, of whom 16 were exclusively breast-fed and 12 were bottle-fed with cow's milk. In addition, beta-casein antibodies were measured in 37 prepubertal children with Type 1 diabetes and in 31 healthy children who were exposed to cow's milk or dairy products to see whether differences in antibody titers exist in this young age group. Antibodies binding to beta-casein were also evaluated by immunoblotting analysis. RESULTS: Elevated levels of beta-casein antibodies were found in bottle-fed infants compared to breast-fed infants (p<0.0001). Antibody levels to bovine beta-casein were also significantly higher in children with Type 1 diabetes compared to age-matched controls (p=0.03). By western blot analysis we confirmed specific binding to bovine beta-casein in bottle-fed infants, in children with Type 1 diabetes and in controls exposed to cow's milk, but not in infants who were exclusively breast-fed. CONCLUSIONS: The results of this study indicate that breastfeeding within the first 4 months of life prevents the generation of antibody response to bovine beta-casein despite the mothers' consumption of cow's milk during the breastfeeding period. These findings may have relevance for disease prevention. Copyright 2000 John Wiley & Sons, Ltd.

PMID: 11241891 [PubMed - indexed for MEDLINE]



Breastfeeding and chronic disease in childhood and adolescence.

Davis MK.

Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia.

A growing body of research suggests that infant feeding practices influence the risk for several chronic diseases of childhood and adolescence. Increased risks for type 1 diabetes, celiac disease, some childhood cancers, and inflammatory bowel disease have been associated with artificial infant feeding and short-term breastfeeding. As genetic susceptibility is understood more completely and gene-environment interactions are elucidated, evidence to either confirm or refute these findings will be forthcoming.



Seasonal variation of birth month and breastfeeding in children with diabetes mellitus.

Samuelsson U, Ludvigsson J.

Department of Health and Environment, Linkoping University,
Sweden. Ulf.Samuelsson@lio.se

OBJECTIVE: As breastfeeding is suggested to protect against diabetes mellitus we decided to investigate whether the seasonal variation of month of birth of diabetic children, with more diabetes in children born in summer, can be explained to some extent by a seasonal variation of exclusive breastfeeding. PATIENTS: A population-based group of 297 children who had been diagnosed with diabetes mellitus before the age of 15 years was compared with 792 matched healthy subjects. RESULTS: There was no difference in duration of breast-feeding between children who later got diabetes and the controls. Children (both diabetics and controls) born during the summer were exclusively breastfed for a mean period of 2.2 months. Corresponding figures for children born during winter were 2.8 months (p<0.04), spring 2.5 months (n.s.) and autumn 2.7 months (p<0.05). Seasonality was most pronounced in children who developed diabetes between the ages of 10 and 15 years. CONCLUSION: These results indicate that children born during the summer, who have increased risk of developing diabetes mellitus, have also been exclusively breastfed for a shorter time.



Short-term exclusive breastfeeding predisposes young children with increased genetic risk of Type I diabetes to progressive beta-cell autoimmunity.

Kimpimaki T, Erkkola M, Korhonen S, Kupila A, Virtanen SM, Ilonen J, Simell O, Knip M.

Department of Pediatrics,
Tampere University Hospital, Finland.

AIMS/HYPOTHESIS: This study aimed to establish the relation between early infant nutrition and signs of beta-cell autoimmunity in young children. METHODS: We identified and observed from birth 2949 infants with increased genetic risk of Type I (insulin-dependent) diabetes mellitus (HLA DQB1*02/ *0302 or DQB1*0302/x, x = other than *02, *0301 or *0602) and monitored them for islet cell antibodies at 3 to 6 month intervals. If an infant seroconverted to islet cell antibody positivity, all of his or her samples were also analysed for autoantibodies to insulin, GAD65 (GADA) and to the protein tyrosine phosphatase related IA-2 molecule (IA-2A). Our case-control study comprises the first 65 children who seroconverted to islet cell antibody positivity before the age of 4 years and 390 control children who were islet cell antibody-negative (six control children/ case). We monitored the duration of exclusive and total breastfeeding and the age at which cows' milk was introduced. RESULTS: Infants who had been breastfed exclusively for at least 4 months had lower risk of seroconversion to positivity for IA-2A or all four autoantibodies [odds ratio (OR) 0.24; 95 % CI 0.06-0.94 and OR 0.17; 95 % CI 0.03-0.86, respectively] than those infants who had been breastfed exclusively for less than 2 months. The risk of seroconversion to positivity for IA-2A or all four autoantibodies was higher in those younger than 2 months (OR 4.37; 95 % CI 1.33-14.42 and OR 5.02; 95 % CI 1.27-19.89) or aged 2 to 3.9 months (OR 5.50; 95 % CI 1.21-25.04 and 6.19; 95% CI 1.10-34.84) when they first received cows' milk than in those aged 4 months or older. CONCLUSIONS/INTERPRETATION: These observations suggest that short-term breastfeeding and the early introduction of cows' milk-based infant formula predispose young children who are genetically susceptible to Type I diabetes to progressive signs of beta-cell autoimmunity.


Cow's milk and immune-mediated diabetes.

Wasmuth HE, Kolb H.

German Diabetes Research Institute at the University of
Dusseldorf, Auf'm Hennekamp 65, 40225 Dusseldorf, Germany.

Cow's milk-based infant formulas and cow's milk consumption in childhood have been suggested to promote the development of type 1 diabetes mellitus and other immune-mediated or neurological diseases. Epidemiological studies in man have led to the hypothesis that introduction of cow's milk-based infant formula within the first 3 months of life is associated with increased risk of type 1 diabetes mellitus. Furthermore, in animal models of type 1 diabetes mellitus, cow's milk proteins have been proven to be 'diabetogenic'. However, the issue seems far from being resolved. Several epidemiological studies and, more importantly, the first prospective trials did not show an association between early exposure to cow's milk and type 1 diabetes mellitus. In animal models, cow's milk proteins are modestly and variably diabetogenic, wheat or soybean proteins in the diet cause higher rates of autoimmune diabetes. In both man and rodents there is increasing evidence that the gut-associated immune system plays a major role in disease development, probably because of disturbed oral tolerance mechanisms. Oral tolerance depends on immunological homeostasis and normal maturation of the gut. These factors are influenced by growth factors and cytokines from breast milk, normal bacterial colonization, infections and diet. All these factors have been proposed as risk factors for type 1 diabetes mellitus. Hence, cow's milk proteins may provide mimicry epitopes relevant in autoimmunity, as well as destabilizing oral tolerance mechanisms by biologically active peptides. The concept of dietary regulation of autoimmunity does not apply only to cow's milk protein, but also to other dietary proteins.