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.
Oral nutritional supplements combined with dietary counseling showed statistically significant improvements in growth metrics in undernourished children, but the clinical relevance of these findings may be limited.
Where it sits
this study against the rest of the alexamorelin corpusSummary and findings
This study measured the effects of an oral nutritional supplement (ONS) on growth and body composition in undernourished Thai children aged 1-6 years. The children were randomized to receive either dietary counseling alone or counseling plus 420 mL/day of ONS for 3 months. The ONS group showed higher gains in weight, height, and body composition metrics compared to the dietary counseling group.
Abstract
<h4>Purpose</h4>This study investigated the effect of oral nutritional supplement (ONS) on growth and body composition in undernourished children.<h4>Methods</h4>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.<h4>Results</h4>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].<h4>Conclusions</h4>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.<h4>Category of study</h4>Randomized controlled trials.
Background
The study addresses the clinical question of how oral nutritional supplements can impact growth and body composition in malnourished children. Prior research has indicated that nutritional interventions can improve health outcomes in this population, but specific effects of ONS in young children had not been thoroughly investigated. This study aims to fill that gap by providing evidence from a randomized controlled trial.
Methods
This multi-center randomized controlled trial involved Thai children aged 1-6 years with weight-for-height z-scores between -1 SD and -3 SD. A total of 159 children were randomized (1:1) to receive either dietary counseling alone or counseling plus 420 mL/day of a cow's milk-based ONS for 3 months. Primary outcome measures included weight, height, and body composition assessed via bioelectrical impedance analysis in children aged ≥3 years.
Results
The primary endpoint showed that the ONS group had a weight gain of 0.16 kg (95% CI: 0.04-0.28) compared to the dietary counseling group after 3 months. Additionally, height gain was 0.42 cm (95% CI: 0.05-0.79), and improvements were seen in weight-for-age and weight-for-height z-scores. Fat-free mass gains were also significantly higher in the ONS group at both 1 and 3 months.
Interpretation
The findings suggest that ONS can lead to statistically significant improvements in growth metrics compared to dietary counseling alone. However, the clinical significance of these changes may be limited, as the effect sizes for some outcomes are relatively small. The study's limitations, including a small sample size and potential biases from dietary counseling, may affect the robustness of the conclusions.
Key findings
- Weight gain: 0.16 kg (95% CI: 0.04-0.28) after 3 months, n=159.
- Height gain: 0.42 cm (95% CI: 0.05-0.79) after 3 months, n=159.
- Weight-for-age z-score increase: 0.10 (95% CI: 0.01-0.18) after 3 months, n=159.
- Weight-for-height z-score increase: 0.13 (95% CI: -0.02 to 0.27) after 3 months, n=159.
- Fat-free mass gain at 3 months: 0.36 kg (95% CI: 0.10-0.63), n=159.
Limitations
- small sample size (n=159)
- short follow-up duration of 3 months
- potential bias from self-reported dietary counseling
- not all children assessed for body composition
- multi-center study may have variability in implementation