Introduction: Adequate nutrition plays an important role in linear growth throughout childhood, including puberty. However, not all children are willing or able to consume an adequate balanced diet daily. We aimed to evaluate the 1-year effectiveness and safety of nutritional supplementation on linear growth, weight gain, and changes in body composition in short and lean peripubertal boys. Methods: A one-year, 2-phase multicenter interventional study comprising 1-6 months of a double-blinded intervention with nutritional formula or placebo, followed by 6-12 months of an open-label extension with the nutritional formula for all participants. Results: The outcomes of the double-blinded intervention were reported previously. A total of 79/98 (81%) boys, aged ≥10 years, Tanner stages 1-3, completed the open-labeled extension-phase. For this phase, a significant dose-response correlation (P<0.05) was found of the consumption of the formula with Δ height-SDS, Δ weight-SDS, and Δ muscle-mass (crude correlations and after adjustment for baseline age and end-of-study Tanner stage). In the extension phase and in the 12-month analysis, participants who were good formula consumers (intake ≥50% of recommended dose) maintained their height-SDS, while poor consumers had a significant decline in their height-SDS (P=0.028 and P=0.009, between group difference in the extension phase and 12-months analysis, respectively). Between-group differences were not observed in Tanner stage at any point of the study. No serious adverse events were reported. Conclusions: An intervention in healthy peripubertal boys suggests that one year consumption of a multi-nutrient, protein-rich nutritional supplement is efficacious and safe. The induced changes in growth and body composition, although modest, may be clinically significant. The effect of the formula on growth parameters was not mediated by enhancement of the pubertal tempo.


中文翻译：

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干预一年后，营养补充剂对矮瘦青春期前男孩生长和身体成分的影响

简介：充足的营养对整个儿童时期（包括青春期）的线性生长起着重要作用。然而，并非所有儿童都愿意或能够每天进食足够均衡的饮食。我们的目的是评估营养补充剂对矮小和苗条的青春期男孩线性生长、体重增加和身体成分变化的 1 年有效性和安全性。方法：一项为期一年、两阶段的多中心干预研究，包括 1-6 个月的营养配方或安慰剂双盲干预，然后是 6-12 个月的开放标签扩展，所有参与者都使用营养配方。结果：先前报告了双盲干预的结果。共有 79/98 (81%) 名年龄≥10 岁的 Tanner 1-3 期男孩完成了开放标记的扩展期。对于这个阶段，发现食用配方奶粉与 Δ 身高-SDS、Δ 体重-SDS 和 Δ 肌肉质量之间存在显着的剂量反应相关性 (P<0.05)（粗相关，并在针对基线年龄和研究结束进行调整后坦纳阶段）。在扩展阶段和为期 12 个月的分析中，良好配方奶消费者（摄入量≥推荐剂量的 50%）的参与者保持了他们的身高 SDS，而不良消费者的身高 SDS 显着下降（P=0.028 和P = 0.009，分别在扩展阶段和 12 个月分析中的组间差异）。在研究的任何时间点，在 Tanner 分期均未观察到组间差异。没有报告严重的不良事件。结论：对健康围青春期男孩的干预表明，一年摄入多种营养素、富含蛋白质的营养补充剂有效且安全。生长和身体成分的诱发变化虽然不大，但可能具有临床意义。配方对生长参数的影响不是通过提高青春期节奏来调节的。