Open AccessDietary compliance in a randomized double‐blind infant feeding trial during infancy aiming at prevention of type 1 diabetes
Author(s) -
Virtanen Suvi M.,
Cuthbertson David,
Nucci Anita M.,
Hyytinen Mila,
Ormisson Anne,
Salonen Marja,
Turrini Tania,
Cummings Elizabeth A.,
Bradley Brenda,
TannerBlasiar Marilyn,
Becker Dorothy J.,
Åkerblom Hans K.,
Savilahti Erkki,
Krischer Jeffrey P.,
Knip Mikael
Publication year - 2021
Publication title -
food science and nutrition
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.614
H-Index - 27
ISSN - 2048-7177
DOI - 10.1002/fsn3.2389
Subject(s) - medicine , infant formula , randomized controlled trial , diabetes mellitus , type 1 diabetes , population , pediatrics , type 2 diabetes , physiology , endocrinology , environmental health
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.