Virtanen Suvi M, Cuthbertson David, Nucci Anita M, Hyytinen Mila, Ormisson Anne, Salonen Marja, Turrini Tania, Cummings Elizabeth A, Bradley Brenda, Tanner-Blasiar Marilyn, Becker Dorothy J, Åkerblom Hans K, Savilahti Erkki, Krischer Jeffrey P, Knip Mikael
Health and Well-Being Promotion Unit Finnish Institute for Health and Welfare Helsinki Finland.
Faculty of Social Sciences/Unit of Health Sciences Tampere University Tampere Finland.
Food Sci Nutr. 2021 Jun 23;9(8):4221-4231. doi: 10.1002/fsn3.2389. eCollection 2021 Aug.
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.
国际降低遗传易患1型糖尿病风险（TRIGR）试验检验了基于深度水解酪蛋白的婴儿配方奶粉与常规牛奶配方奶粉相比是否能降低1型糖尿病风险这一假设。我们从研究配方奶粉摄入量、非推荐食物喂养情况以及反映牛奶蛋白摄入量的血清牛奶抗体浓度等方面，描述了该试验中2159名符合条件的新生儿的饮食依从性。这些新生儿均有一位受1型糖尿病影响的生物学一级亲属，且具有1型糖尿病的HLA易感性。参与试验的婴儿在15天龄的中位数时开始接受研究配方奶粉喂养，研究配方奶粉的使用持续时间中位数为63天。在干预期间，80%的婴儿接受了研究配方奶粉。其中，57%的婴儿接受研究配方奶粉至少2个月。平均每名婴儿使用了45.5升研究配方奶粉。到6个月龄时，只有13%的人群食用过非推荐食物。干预组和对照组的饮食依从性相似。家庭报告的牛奶消费量与测得的血清酪蛋白IgA和IgG抗体浓度非常匹配。总之，在这项随机婴儿喂养试验中观察到了良好的依从性。依从性在不同地区有所差异，母乳喂养时间较长的婴儿接触研究配方奶粉的时间较短。婴儿喂养试验中的高饮食依从性对于准确解读研究结果是必要的。
