Removal of Bovine Insulin From Cow's Milk Formula and Early Initiation of Beta-Cell Autoimmunity in the FINDIA Pilot Study
Abstract
OBJECTIVE To test whether weaning to a bovine insulin-free cow's milk formula (CMF) reduces type 1 diabetes mellitus-associated autoantibodies in children at genetic risk. DESIGN Randomized, double-blind pilot trial (Finnish Dietary Intervention Trial for the Prevention of Type 1 Diabetes [FINDIA]). SETTING Three pediatric hospitals in Finland from May 15, 2002, to November 22, 2005. PARTICIPANTS A total of 1113 infants with HLA-conferred susceptibility to type 1 diabetes were randomly assigned to receive study infant formulas; 908 children provided at least 1 follow-up blood sample (last follow-up, June 2009). INTERVENTION The CMF (n = 389), whey-based hydrolyzed formula (WHF) (n = 350), or whey-based FINDIA formula essentially free of bovine insulin (n = 365) during the first 6 months of life whenever breast milk was not available. MAIN OUTCOME MEASURES Primary outcome was beta-cell autoimmunity monitored at ages 3, 6, and 12 months and then annually until age 3 years. Autoantibodies to insulin, the 65-kDa isoform of glutamic acid decarboxylase, and the tyrosine phosphatase-related IA-2 molecule were screened, and islet cell autoantibodies and autoantibodies to zinc transporter 8 were analyzed in infants whose primary screening test results were positive. RESULTS In the intention-to-treat analysis, 6.3% of children in the CMF group, 4.9% of those in the WHF group, and 2.6% of children in the FINDIA group were positive for at least 1 autoantibody by age 3 years. The odds rat…
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Another trial removed bovine insulin from infant formula and reported less progression to the development of one islet autoantibody after 3 years of follow-up compared with infants who received normal cow's milk formula.
“Another trial removed bovine insulin from infant formula and reported less progression (compared with infants who received normal cow's milk formula) to the development of one islet autoantibody after 3 years of follow-up.129”
From Type 1 diabetes (2014) · cites this paper as [129]
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- Authors
- Vaarala, O., Ilonen, J., Ruohtula, T., Pesola, J., Virtanen, S. M., Härkönen, T., Koski, M., Kallioinen, H., Tossavainen, O., Poussa, T., Järvenpää, A.-L., Komulainen, J., Lounamaa, R., Åkerblom, H. K., & Knip, M.
- Affiliations
- Finnish Institute for Health and Welfare (FI)
- University of Turku (FI)
- University of Eastern Finland (FI)
- University of Helsinki (FI)
- Valio (Finland) (FI)
- Kuopio University Hospital (FI)
- Corresponding author
- Vaarala, Outi
- ORCID
- Venue
- Archives of Pediatrics & Adolescent Medicine
- Publisher
- American Medical Association (AMA)
- Published
- 2012-07-01
- Volume
- 166
- Issue
- 7
- Pages
- 608
- ISSN
- 1072-4710 (ISSN-L)
- OpenAlex
- W2101085902
- Cited by
- 127
- References
- 42
- Citations by year
- 2026: 3 · 2025: 2 · 2024: 15 · 2023: 8 · 2022: 8 · 2021: 7 · 2020: 11 · 2019: 12 · 2018: 7 · 2017: 9 · 2016: 10 · 2015: 5 · 2014: 12 · 2013: 13 · 2012: 5
- FWCI
- 6.75
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Archives of Pediatrics and Adolescent Medicine (publishedVersion)
- PubMed (publishedVersion)
- STM:n Hallinnonalan avoin julkaisuarkisto (Julkari) (submittedVersion)
- 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 › Gastroenterology › Celiac Disease Research and Management
- Keywords
- type 1 diabetes prevention, bovine insulin, cow's milk formula, islet autoimmunity, islet autoantibodies, infant formula, HLA-DQ2, HLA-DQ8, glutamic acid decarboxylase antibodies, insulin autoantibodies, zinc transporter 8 autoantibodies, weaning
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