Effects of oral nutritional supplement on growth and body composition in malnutrition at risk and malnourished children: MARVEL study, a multi-center randomized controlled trial

Abstract

Purpose: This study investigated the effect of oral nutritional supplement (ONS) on growth and body composition in undernourished children. Methods: Thai children aged 1–6 years with weight-for-height (WFH) z-scores between − 1 SD and − 3 SD were randomized (1:1) to receive either dietary counselling alone (DC group) or counselling plus 420 mL/day of a cow’s milk–based ONS (1 kcal/mL; energy distribution: 10% protein, 49% carbohydrate, 41% fat; fortified with calcium, vitamin D, iron, and zinc) for 3 months. Weight and height were measured at baseline, 1, and 3 months and compared with WHO standards. Body composition was assessed via bioelectrical impedance analysis in children aged ≥ 3 years old at the same period. Results: A total of 159 children (78 DC and 81 ONS), with mean ages (95% CI) of 3.5 (3.15–3.90) and 3.49 (3.10–3.90) years, were included. After 3 months, the ONS group demonstrated higher gains in weight, height, weight-for-age (WFA) and weight-for-height (WFH) z-score compared to the DC group [mean difference (95% CI): weight 0.16 (0.04–0.28) kg; height: 0.42 (0.05–0.79) cm; WFA z-score: 0.10 (0.01–0.18); WFH z-score: 0.13 (− 0.02 to 0.27)]. Gains in fat-free mass were higher with ONS at both 1 and 3 months [mean difference (95%CI): 0.26 (0.01–0.50) and 0.36 (0.10–0.63) kg]. Soft lean mass gain was also significantly greater in the ONS group at 3 months [0.39 (0.11–0.68) kg]. Conclusions: ONS combined with dietary counselling improved growth and fat-free mass, supporting its role in promoting healthier body composition and long-term metabolic health. TCTR20220908004. Category of study: Randomized controlled trials.