Dietary compliance in a randomized double-blind infant feeding trial during infancy aiming at prevention of type 1 diabetes

Suvi M. Virtanen, David Cuthbertson, Anita M. Nucci, Mila Hyytinen, Anne Ormisson, Marja Salonen, Tania Turrini, Elizabeth A. Cummings, Brenda Bradley, Marilyn Tanner-Blasiar, Dorothy J. Becker, Hans K. Åkerblom, Erkki Savilahti, Jeffrey P. Krischer, Mikael Knip, The TRIGR Investigators

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The international Trial to Reduce IDDM in the Genetically at Risk (TRIGR) tested the hypothesis whether extensively hydrolyzed casein-based versus regular cow's milk-based infant formula reduces the risk of type 1 diabetes. We describe dietary compliance in the trial in terms of study formula intake, feeding of nonrecommended foods, and serum cow's milk antibody concentration reflecting intake of cow's milk protein among 2,159 eligible newborn infants with a biological first-degree relative affected by type 1 diabetes and with HLA-conferred susceptibility to type 1 diabetes. The participating infants were introduced to the study formula feeding at the median age of 15 days with a median duration of study formula use of 63 days. During the intervention, 80% of the infants received study formula. Of these, 57% received study formula for at least 2 months. On average, 45.5 l of study formula were used per infant. Only 13% of the population had received a nonrecommended food by the age of 6 months. The dietary compliance was similar in the intervention and control arm. The reported cow's milk consumption by the families matched very well with measured serum casein IgA and IgG antibody concentration. To conclude, good compliance was observed in this randomized infant feeding trial. Compliance varied between the regions and those infants who were breastfed for a longer period of time had a shorter exposure to the study formula. High dietary compliance in infant feeding trial is necessary to allow accurate interpretation of study results.

Original languageEnglish
JournalFood Science and Nutrition
Issue number8
Publication statusPublished - 2021
Publication typeA1 Journal article-refereed


  • infant and child nutrition
  • infant feeding
  • infant formula
  • nutritional interventions
  • randomized controlled trial
  • research methodology
  • type 1 diabetes

Publication forum classification

  • Publication forum level 1

ASJC Scopus subject areas

  • Food Science


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