Effect of milk protein and whey permeate in large quantity lipid-based nutrient supplement on linear growth and body composition among stunted children: A randomized 2 × 2 factorial trial in Uganda.

BACKGROUND: Despite possible benefits for growth, milk is costly to include in foods for undernourished children. Furthermore, the relative effects of different milk components, milk protein (MP), and whey permeate (WP) are unclear. We aimed to assess the effects of MP and WP in lipid-based nutrient supplement (LNS), and of LNS itself, on linear growth and body composition among stunted children. METHODS AND FINDINGS: We performed a randomized, double-blind, 2 × 2 factorial trial among 12 to 59 months old stunted children in Uganda. Children were randomized to 4 formulations of LNS with MP or soy protein isolate and WP or maltodextrin (100 g/day for 12 weeks) or no supplementation. Investigators and outcome assessors were blinded; however, participants were only blinded to the ingredients in LNS. Data were analyzed based on intention-to-treat (ITT) using linear mixed-effects models adjusted for age, sex, season, and site. Primary outcomes were change in height and knee-heel length, and secondary outcomes included body composition by bioimpedance analysis (ISRCTN13093195). Between February and September 2020, we enrolled 750 children with a median age of 30 (interquartile range 23 to 41) months, with mean (± standard deviation) height-for-age z-score (HAZ) -3.02 ± 0.74 and 12.7% (95) were breastfed. The 750 children were randomized to LNS (n = 600) with or without MP (n = 299 versus n = 301) and WP (n = 301 versus n = 299), or no supplementation (n = 150); 736 (98.1%), evenly distributed between groups, completed 12-week follow-up. Eleven serious adverse events occurred in 10 (1.3%) children, mainly hospitalization with malaria and anemia, all deemed unrelated to the intervention. Unsupplemented children had 0.06 (95% confidence interval, CI [0.02, 0.10]; p = 0.015) decline in HAZ, accompanied by 0.29 (95% CI [0.20, 0.39]; p < 0.001) kg/m2 increase in fat mass index (FMI), but 0.06 (95% CI [-0.002; 0.12]; p = 0.057) kg/m2 decline in fat-free mass index (FFMI). There were no interactions between MP and WP. The main effects of MP were 0.03 (95% CI [-0.10, 0.16]; p = 0.662) cm in height and 0.2 (95% CI [-0.3, 0.7]; p = 0.389) mm in knee-heel length. The main effects of WP were -0.08 (95% CI [-0.21, 0.05]; p = 220) cm and -0.2 (95% CI [-0.7; 0.3]; p = 403) mm, respectively. Interactions were found between WP and breastfeeding with respect to linear growth (p < 0.02), due to positive effects among breastfed and negative effects among non-breastfed children. Overall, LNS resulted in 0.56 (95% CI [0.42, 0.70]; p < 0.001) cm height increase, corresponding to 0.17 (95% CI [0.13, 0.21]; p < 0.001) HAZ increase, and 0.21 (95% CI [0.14, 0.28]; p < 0.001) kg weight increase, of which 76.5% (95% CI [61.9; 91.1]) was fat-free mass. Using height-adjusted indicators, LNS increased FFMI (0.07 kg/m2, 95% CI [0.0001; 0.13]; p = 0.049), but not FMI (0.01 kg/m2, 95% CI [-0.10, 0.12]; p = 0.800). Main limitations were lack of blinding of caregivers and short study duration. CONCLUSIONS: Adding dairy to LNS has no additional effects on linear growth or body composition in stunted children aged 12 to 59 months. However, supplementation with LNS, irrespective of milk, supports linear catch-up growth and accretion of fat-free mass, but not fat mass. If left untreated, children already on a stunting trajectory gain fat at the expense of fat-free mass, thus nutrition programs to treat such children should be considered. TRIAL REGISTRATION: ISRCTN13093195.

Calibration of Bioelectrical Impedance Analysis Against Deuterium Dilution for Body Composition Assessment in Stunted Ugandan Children.

BACKGROUND: BIA represents an important tool in body composition (BC) assessment, especially in low-income settings in which simple and affordable options are preferred. There is a particular need to measure BC in stunted children, in which cases population-specific BIA estimating equations are lacking. OBJECTIVES: We calibrated an equation to estimate body composition from BIA using deuterium dilution (2H) as the criterion method in stunted children. METHODS: We measured BC with 2H and performed BIA in stunted Ugandan children (n = 50). Multiple linear regression models were constructed to predict 2H-derived FFM from BIA-derived whole-body impedance and other relevant predictors. Model performance was expressed as adjusted R2 and RMSE. Prediction errors were also calculated. RESULTS: Participants were aged 16-59 mo, of whom 46% were girls, and their median (IQR) height-for-age z-score (HAZ) was -2.58 (-2.92 to -2.37) according to the WHO growth standards. Impedance index (height2/impedance measured at 50 kHz) alone explained 89.2% variation in FFM and had an RMSE of 583 g (precision error 6.5%). The final model contained age, sex, impedance index, and height-for-age z-score as predictors and explained 94.5% variation in FFM with an RMSE of 402 g (precision error 4.5%). CONCLUSIONS: We present a BIA calibration equation for a group of stunted children with a relatively low prediction error. This may help evaluate the efficacy of nutritional supplementation in large-scale trials in the same population. J Nutr 20XX;xxx:xx.

Correlates of Pancreatic Enzyme Replacement Therapy Intake in Adults with Cystic Fibrosis: Results of a Cross-Sectional Study.

Most people with cystic fibrosis (pwCF) develop pancreatic insufficiency and are treated with pancreatic enzyme replacement therapy (PERT). We aimed to describe the use of PERT and assess the correlates of PERT dose in adult pwCF. In a cross-sectional study at the Copenhagen CF Centre, the participants reported PERT intake, gastrointestinal (GI) symptoms and the use of concomitant treatments. Demographic and clinical characteristics were extracted from the Danish CF Registry. We used linear regression to assess the correlates of PERT dose per kg bodyweight (U-lipase/kg). We included 120 pwCF with a median age of 32.9 years, 46% women and 72% F508delta homozygote. The PERT dose ranged from 0 to 6160 U-lipase/kg per main meal (mean 1828; SD 1115). The PERT dose was associated with participants' sex (men vs. women: 661; 95% CI: 302; 1020 U-lipase/kg), age (-16; 95% CI: -31; -1 U-lipase/kg per year) and weight (-45; 95% CI: -58; -31 U-lipase/kg per kg). Having less frequent constipation and being lung transplanted were also associated with a higher PERT dose. A third of participants did not take PERT for snacks, and this was associated with the frequency of diarrhoea. These findings indicate that PERT intake may be improved to reduce GI symptoms.

Birthweight z-score and fat-free mass at birth predict body composition at 3 years in Danish children born from obese mothers.

AIM: We investigated associations between newborn body composition and anthropometry and body composition at 3 years in Danish children born from obese mothers. METHODS: Analyses are based on data from the observational cohort study SKOT II (SKOT; small children's diet and well-being (Danish)). Body composition at birth and at 3 years was assessed by dual-energy X-ray absorptiometry (DXA) scans and bioelectrical impedance analysis (BIA), respectively. Multiple linear regression models were applied to determine associations between newborn body composition and anthropometry and body composition at 3 years. RESULTS: Birthweight z-score (BWZ) was positively associated with fat-free mass (FFM), height, fat-free mass index (FFMI), fat mass (FM) and fat mass index (FMI) at 3 years. Newborn FFM was positively associated with FFM, height, FFMI and FM at 3 years, and positive trends were seen between newborn FM and FM and FMI at 3 years. CONCLUSION: We showed that infants born with a higher BWZ go on to be taller at 3 years. They also grow to be heavier, to which FM and FFM both contribute, independently of linear growth. Additionally, it seems that FFM tracks into early childhood, thus supporting intrauterine programming of later health.