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.