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Dietary Intervention in Infancy and Later Signs of Beta-Cell Autoimmunity
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BACKGROUND: Early exposure to complex dietary proteins may increase the risk of beta-cell autoimmunity and type 1 diabetes in children with genetic susceptibility. We tested the hypothesis that supplementing breast milk with highly hydrolyzed milk formula would decrease the cumulative incidence of diabetes-associated autoantibodies in such children. METHODS: In this double-blind, randomized trial, we assigned 230 infants with HLA-conferred susceptibility to type 1 diabetes and at least one family member with type 1 diabetes to receive either a casein hydrolysate formula or a conventional, cow's-milk-based formula (control) whenever breast milk was not available during the first 6 to 8 months of life. Autoantibodies to insulin, glutamic acid decarboxylase (GAD), the insulinoma-associated 2 molecule (IA-2), and zinc transporter 8 were analyzed with the use of radiobinding assays, and islet-cell antibodies were analyzed with the use of immunofluorescence, during a median observation period of 10 years (mean, 7.5). The children were monitored for incident type 1 diabetes until they were 10 years of age. RESULTS: The unadjusted hazard ratio for positivity for one or more autoantibodies in the casein hydrolysate group, as compared with the control group, was 0.54 (95% confidence interval [CI], 0.29 to 0.95), and the hazard ratio adjusted for an observed difference in the duration of exposure to the study formula was 0.51 (95% CI, 0.28 to 0.91). The unadjusted hazard ratio for positivity for two or more autoantibodies was 0.52 (95% CI, 0.21 to 1.17), and the adjusted hazard ratio was 0.47 (95% CI, 0.19 to 1.07). The rate of reported adverse events was similar in the two groups. CONCLUSIONS: Dietary intervention during infancy appears to have a long-lasting effect on markers of beta-cell autoimmunity--markers that may reflect an autoimmune process leading to type 1 diabetes. (ClinicalTrials.gov number, NCT00570102.).
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“Children who received the hydrolysed formula were less likely to develop two or more islet autoantibodies compared with those who received the conventional formula, with an unadjusted hazard ratio of 0·52.128”
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“A study in Finland128 identified 230 infants with a first-degree relative with type 1 diabetes, and randomly assigned infants to receive a hydrolysed infant formula or conventional formula whenever breast milk was not available during the first 6–8 months of life.”
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Metadata
- Authors
- Knip, M., Virtanen, S. M., Seppä, K., Ilonen, J., Savilahti, E., Vaarala, O., Reunanen, A., Teramo, K., Hämäläinen, A.-M., Paronen, J., Dosch, H.-M., Hakulinen, T., & Åkerblom, H. K.
- Affiliations
- University of Helsinki (FI)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2010-11-11
- Volume
- 363
- Issue
- 20
- Pages
- 1900-1908
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC4242902
- OpenAlex
- W1227874083
- Cited by
- 281
- References
- 29
- Citations by year
- 2026: 5 · 2025: 3 · 2024: 11 · 2023: 7 · 2022: 11 · 2021: 12 · 2020: 11 · 2019: 13 · 2018: 17 · 2017: 17 · 2016: 19 · 2015: 20 · 2014: 28 · 2013: 35 · 2012: 39
- FWCI
- 18.91
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- STM:n Hallinnonalan avoin julkaisuarkisto (Julkari) (submittedVersion)
- Funders
- Mead Johnson Nutrition
- Helsingin Yliopisto
- Helsingin ja Uudenmaan Sairaanhoitopiiri
- European Commission (BMH4-CT96-0233)
- Academy of Finland
- Novo Nordisk
- Novo Nordisk Fonden
- Tays
- Diabetestutkimussäätiö
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (U01HD040364)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Health Sciences › Nursing › Nutrition and Dietetics › Infant Nutrition and Health
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Keywords
- type 1 diabetes, islet autoimmunity, dietary intervention, breast milk supplementation, diabetes-associated autoantibodies, insulin autoantibodies, glutamic acid decarboxylase, IA-2, zinc transporter 8, islet cell antibodies, HLA-DQ2/DQ8, genetic susceptibility, infant feeding
- MeSH terms
- Animals, Autoantibodies, Caseins, Child, Diabetes Mellitus, Type 1, Double-Blind Method, Histocompatibility Testing, Humans, Infant, Infant, Newborn, Milk, Milk, Human, Pilot Projects, Biomarkers, Autoimmunity, Disease Progression, Genetic Predisposition to Disease, Infant Formula, Insulin-Secreting Cells
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