Fig. 1: Subjects and design of the clinical trial and effect of the experimental blend on bone and muscle clinical outcomes. | Nature Communications

Fig. 1: Subjects and design of the clinical trial and effect of the experimental blend on bone and muscle clinical outcomes.

From: A young child formula with Limosilactobacillus reuteri and GOS modulates gut microbiome and enhances bone and muscle development: a randomized trial

Fig. 1

A A total of 273 toddlers were enrolled into the study; 182 toddlers were randomized to one of the feeding groups, and 91 toddlers were enrolled in parallel as a reference population. Randomized toddlers were assigned to either a minimally fortified cow milk (CM, n = 91) or an experimental young child formula group (EYCF, n = 91). Overall, 225 (82%) subjects completed the study. In the full analysis set (FAS), the retention rate was 77% in both CM & EYCF groups. Across all groups, 48 toddlers (22 each in CM and EYCF, 4 in REF) withdrew from the study with the common reasons of issues with taste (n = 16; 33%) and transfer to province/other country (n = 15; 31%). Other reasons for withdrawal included relatives’ disapproval (n = 9; 19%), unable to comply (n = 4; 8%), adverse events (n = 2; 4%), and preference to solid food (n = 2; 4%). B Schematic of experimental design. C Tibia speed of sound (SOS) measured by quantitative ultrasound after 6 months of intervention. D Longitudinal tibia SOS. E Bone turnover marker (CTx-P1NP)/P1NP. CTX: carboxy-terminal collagen crosslinks, P1NP: Procollagen type I N-terminal propeptide. Anthropometric outcomes: F Head circumference, G Tibia length, H Height for age, I Weight for age. J Muscle force (right arm) measured by handgrip. For all outcomes, EYCF and CM groups n = 69. Data are presented as mean ± SD for C, E, and mean ± SEM for D, F, G, H, I, B, *P < 0.05, **P < 0.01, compared to the CM group.

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