References
Gastrointestinal adverse, flatulence, breast-fed, vomiting, stomach ache, constipation, weight gain, breast milk
GENETIC DISEASE
Study flowchart. Randomization, allocation and follow-up in intention-to-treat and per protocol (PP) populations. SF, standard formula; α-lac-EW, experimental formula with α-lactalbumin-enriched whey; CGMP-RW, experimental formula with reduced CGMP whey; BF, breast-fed. Reasons for lost to follow-up: * Gastrointestinal adverse events, such as vomiting, stomach ache, flatulence or constipation. ** Congenital genetic disease affecting growth.Unadjusted mean (95% CI) of z-score weight-for-age (WAZ), length-for-age (LAZ), weight-for-length (WLZ), HC-for-age (HCAZ) and BMI-for-age (BMIZ) in study groups compared by one-way ANOVA, post hoc Bonferroni. Mean (±SD) plasma concentration of essential and nonessential amino acids in the randomized subgroup (n = 50 in each group) at four and six months of age. Groups compared by one-way ANOVA, post hoc Bonferroni. Mean (± SD) total BCCA (isoleucine, leucine, valine) plasma concentration in the randomized subgroup (n = 50 in each group) at four and six months of age. Groups compared by one-way ANOVA, post hoc Bonferroni. Energy and protein content in study formulas * and minimum levels according to regulation.* SF, standard formula; α-lac-EW, experimental formula with α-lactalbumin-enriched whey; CGMP-RW, experimental formula with reduced CGMP whey. Baseline characteristics of parents and infants fed formula (SF, α-lac-EW or CGMP-RW) * or breast milk (BF), ITT population.* SF, standard formula; α-lac-EW, experimental formula with α-lactalbumin-enriched whey; CGMP-RW, experimental formula with reduced CGMP whey.** All FF = infant formula groups combined.Infant formula, energy and protein intake in infants fed formula (SF, α-lac-EW or CGMP-RW) * during the intervention, ITT population.* SF, standard formula; α-lac-EW, experimental formula with α-lactalbumin-enriched whey; CGMP-RW, experimental formula with reduced CGMP whey. Anthropometric data and growth velocity in infants fed formula (SF, α-lac-EW or CGMP-RW) * or breast milk (BF) during the intervention, ITT population.* SF, standard formula; α-lac-EW, experimental formula with α-lactalbumin-enriched whey; CGMP-RW, experimental formula with reduced CGMP whey. Mean weight and weight gain in infants fed formula (SF, α-lac-EW or CGMP-RW) * or breast milk (BF) during the intervention, PP population.* SF, standard formula; α-lac-EW, experimental formula with α-lactalbumin-enriched whey; CGMP-RW, experimental formula with reduced CGMP whey. Energy efficiency in infants fed formula (SF, α-lac-EW or CGMP-RW) * during the intervention, ITT population.* SF, standard formula; α-lac-EW, experimental formula with α-lactalbumin-enriched whey; CGMP-RW, experimental formula with reduced CGMP whey. Mean concentration (unadjusted) of blood urea nitrogen (BUN), s-IGF-1, insulin, c-peptide, leptin, leptin receptor, free leptin receptor index (FLI), hemoglobin (Hb), ferritin and iron in infants fed formula (SF, α-lac-EW or CGMP-RW) * or breast milk (BF) during the intervention, ITT population, and for BUN in the randomized subgroup.* SF, standard formula; α-lac-EW, experimental formula with α-lactalbumin-enriched whey; CGMP-RW, experimental formula with reduced CGMP whey. 