Real-World Effectiveness of a New Growing Up Milk on Digestive Comfort and Social-Emotional Outcomes Among Healthy Toddlers in China

Objectives Existing clinical evidence indicates infant formulas containing bovine milk-derived oligosaccharides (MOS) promote soft stools and gut health among young infants. This prospective single-arm study aimed to assess effectiveness of a new growing-up milk (GUM) containing MOS and milk fat (naturally contains sn-2 palmitate) on digestive and social-emotional outcomes among healthy toddlers. Methods Toddlers age 12–36 months were enrolled from an urban area in China to receive the GUM for 28 days. Overall digestive comfort (primary outcome) was assessed by the Gut Comfort Composite Score (GCCS; range 10–60 with increasing scores for higher GI burden) from the 10-item Toddler Gut Comfort Questionnaire (Meng 2019). Other parent-reported culturally relevant outcomes included heatiness based on individual symptoms via Child Heatiness Questionnaire (Sheng 2020; total score range 0–10), and social-emotional outcomes via 3-day mood diary and Children's Playfulness Scale (Li 1995; range 0–69). Results A total of 98 toddlers were enrolled and completed the study. While overall GI burden was low at baseline (mean ± SD GCCS: 15.7 ± 4.7; range 10–32), GCCS at post-baseline visits was further reduced (14.7 ± 4.7 at D7, p = 0.02; 13.5 ± 4.0 at D14, p < 0.001; 13.3 ± 3.6 at D28, p < 0.001). Parental report for child heatiness was reduced over study period (0.5 ± 1.2 at D28 vs. 1.0 ± 1.5 [range 0–7] at baseline, p = 0.002). Percentage of toddlers with heatiness (composite score > 0) was 40% at baseline and reduced to 26% by D28 (p = 0.011). Parents reported that their toddlers’ playful behaviors became more important to them by D28 from baseline (median [IQR]: 62 [13] vs. 58 [11.5], p = 0.002). Over 94% of parents reported their toddlers exhibited happy moods at each post-baseline visit, although not statistically different from baseline. Furthermore, lower gut comfort score was associated with more playful behaviors (p < 0.001) and happier mood during daytime (p < 0.001). Over 95% of parents reported their toddlers liked the taste of the GUM and felt happy when drinking it, while 98% of toddlers indicated they liked to drink the GUM. Conclusions Consumption of a new GUM with MOS and milk fat is associated with improved gut comfort, increased importance of playfulness and reduced heatiness. Parents also reported happy toddler moods and high satisfaction. Funding Sources Sponsored by Wyeth Nutrition.