Dietary intervention in infancy and later signs of beta-cell autoimmunity
Open accessAbstract
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.
“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”
From Type 1 diabetes (2014) · cites this paper as [128]
A study in Finland 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.
“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.”
From Type 1 diabetes (2014) · cites this paper as [128]
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Self-citationAllaitement maternel : les bénéfices pour la santé de l'enfant et de sa mère
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Self-citationProgress in immune-based therapies for type 1 diabetes
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Dietary factors in the development of type 1 diabetes
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Self-citationManagement of diabetes mellitus in infants
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Effects of Pasteurization on Adiponectin and Insulin Concentrations in Donor Human Milk
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Is Cow's Milk Harmful to a Child's Health?
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Blood-based signatures in type 1 diabetes
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Self-citationMasala, S., Paccagnini, D., Cossu, D., Brezar, V., Pacifico, A., Ahmed, N., Mallone, R., & Sechi, L. A. (2011) · PLoS ONE · doi:10.1371/journal.pone.0026931 · Cited by 61 · see citing works
Glycotoxin and Autoantibodies Are Additive Environmentally Determined Predictors of Type 1 Diabetes
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Self-citationIntroduction to ISPAD Clinical Practice Consensus Guidelines 2014 Compendium
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Metabolic alterations in immune cells associate with progression to type 1 diabetes
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Self-citationHope vs hype: where are we in type 1 diabetes?
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Dysregulation of secondary bile acid metabolism precedes islet autoimmunity and type 1 diabetes
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Self-citationLempainen, J., Tauriainen, S., Vaarala, O., Mäkelä, M., Honkanen, H., Marttila, J., Veijola, R., Simell, O., Hyöty, H., Knip, M., et al. (2011) · Diabetes/Metabolism Research and Reviews · doi:10.1002/dmrr.1294 · Cited by 53 · see citing works
Self-citationSARS-CoV-2 and type 1 diabetes in children in Finland: an observational study
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Self-citationComplementary Feeding: Tradition, Innovation and Pitfalls
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Allaitement maternel : les bénéfices pour la santé de l’enfant et de sa mère
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Environmental control of autoimmune inflammation in the central nervous system
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Dietary Cows’ Milk Protein A1 Beta-Casein Increases the Incidence of T1D in NOD Mice
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Self-citationImmune intervention in type 1 diabetes
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Self-citationCLARITY – ChiLdhood Arthritis Risk factor Identification sTudY
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Wiberg, A., Granstam, A., Ingvast, S., Härkönen, T., Knip, M., Korsgren, O., & Skog, O. (2015) · Clinical & Experimental Immunology · doi:10.1111/cei.12698 · Cited by 43 · see citing works
Self-citationThe gut as a regulator of early inflammation in type 1 diabetes
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Self-citationCombination immunotherapy for type 1 diabetes
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Fermentable fibres condition colon microbiota and promote diabetogenesis in NOD mice
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Differential Digestion of Human Milk Proteins in a Simulated Stomach Model
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New and future immunomodulatory therapy in type 1 diabetes
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Self-citationCirculating metabolites in progression to islet autoimmunity and type 1 diabetes
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Self-citationRising incidence and challenges of childhood diabetes. A mini review.
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Risk Factors and Primary Prevention Trials for Type 1 Diabetes
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Common ground: shared risk factors for type 1 diabetes and celiac disease
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Land Cover of Early-Life Environment Modulates the Risk of Type 1 Diabetes
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- 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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