Efficacy of long-term oral nutritional supplementation with dietary counseling on growth, body composition and bone mineralization in children with or at risk for undernutrition: a randomized controlled trial.

BACKGROUND

Impaired growth, accompanied by low lean mass and poor bone mineralization in undernourished children, is linked to adverse short- and long-term health outcomes. Oral nutritional supplements (ONS) promote catch-up growth, but their efficacy in improving lean mass and bone mineralization remains uninvestigated. This study aims to compare the efficacy of long-term ONS with dietary counseling (DC) versus DC alone on growth, body composition, bone mineralization, and health outcomes in children with or at risk of undernutrition.

METHODS

Children (n = 330) aged 24-60 months with WHO Growth Standard z-scores of weight-for-age < - 1, height-for-age < - 1, and weight-for-height < 0 were randomized in a multisite controlled trial to receive two servings of a complete and balanced ONS formula with DC, or DC-only, for 240 days. Anthropometric measurements, dietary intake, and parent-reported measures of illness-related and other health outcomes were assessed at baseline and days 30, 120, and 240. Dual X-ray absorptiometry-assessed body composition and bone mineralization, and nutritional blood biomarkers were measured at baseline and day 240.

RESULTS

ONS supplementation augmented growth in height and weight through day 240, with increasing between-group differences over visits (P < 0.01 for treatment-by-visit interaction in height, weight, height-for-age and weight-for-age z-scores). Energy and protein intake levels were 26% and 22% higher, respectively, in the ONS + DC compared to the DC-group at day 240 (both P < 0.001). The ONS + DC group also had a higher lean mass index of 11.06 (0.05) versus 10.92 (0.05) kg/m2 (P = 0.048) and total body less head bone mineral density of 0.407 (0.003) versus 0.399 (0.003) g/cm2 (P = 0.03) at day 240, with no differences in fat mass index compared to DC. The ONS + DC group also had better serum vitamin D and K status, fewer sick and missed school days, better parent-reported sleep habits, appetite, energy, and physical activity levels versus DC-group (all P < 0.05).

CONCLUSION

Adding ONS to DC for 8 months improved linear catch-up growth and supported quality growth, as evidenced by greater lean mass and bone mineral accretion. These findings, alongside parent-reported improvements in child health, suggest that improved nutrient intake with ONS improves multiple domains of child health and well-being.

TRIAL REGISTRATION

This clinical trial was registered on ClinicalTrials.gov (registration number: NCT05239208) on 14 February 2022. Video Abstract.