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一项多中心、双盲、随机、安慰剂对照试验,旨在评估 12-23 月龄儿童饮用“成长牛奶 Lite”对其身体成分的影响。

A multicenter, double-blind, randomized, placebo-controlled trial to evaluate the effect of consuming Growing Up Milk "Lite" on body composition in children aged 12-23 mo.

机构信息

Discipline of Nutrition and Dietetics, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.

Children's Nutrition Research Centre, University of Queensland Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Australia.

出版信息

Am J Clin Nutr. 2019 Mar 1;109(3):576-585. doi: 10.1093/ajcn/nqy302.

DOI:10.1093/ajcn/nqy302
PMID:30831579
Abstract

BACKGROUND

Growing Up Milk (GUM) was developed to assist young children in meeting their nutritional requirements during the second year of life. However, there is limited evidence that GUM improves nutritional status and growth in young children.

OBJECTIVES

To evaluate the effect of consuming Growing Up Milk "Lite" (GUMLi) (reduced protein with synbiotics and micronutrients added) compared with standard cow milk as part of a whole diet for 1 y on body composition at 2 y of age.

METHODS

GUMLi Trial was a multicenter, double-blind, randomized placebo-controlled trial conducted in Auckland and Brisbane. Healthy 1-y-olds were recruited and randomly assigned to receive either GUMLi or standard cow milk for 12 mo as part of a whole diet. The primary outcome was percentage body fat at 2 y of age measured by bioelectrical impedance. All regression models adjusted for baseline outcome and study center.

RESULTS

160 children (80 per arm) were randomly assigned, and 134 (67 per arm) were included in the modified intention-to-treat analyses. The mean percentage body fat at 12 mo was 23.3% (SD 7.9) in the GUMLi group and 25.7% (SD 7.2) in the cow milk group. After adjusting for baseline outcome and study location, the estimated mean difference in percentage body fat between the intervention and control at 12 mo was -2.19% (95% CI: -4.24, -0.15; P = 0.036). Per-protocol analysis showed a similar effect (mean difference: -2.09%; 95% CI: -4.16, -0.03; P = 0.047). Both fat mass and the fat mass index were significantly lower in the GUMLi group at 12 mo than in the cow milk group.

CONCLUSIONS

At 2 y of age, children who consumed a GUM with a lower protein content than cow milk over 12 mo had a lower percentage of body fat. This trial was registered at the Australian New Zealand Clinical Trials Registry as ACTRN12614000918628.

摘要

背景

成长牛奶(GUM)旨在帮助幼儿在生命的第二年满足其营养需求。然而,目前几乎没有证据表明 GUM 可以改善幼儿的营养状况和生长。

目的

评估在 1 岁时作为完整饮食的一部分,与标准牛奶相比,食用添加了合生元和微量营养素的低蛋白成长牛奶(GUMLi)对 2 岁时身体成分的影响。

方法

GUMLi 试验是一项多中心、双盲、随机安慰剂对照试验,在奥克兰和布里斯班进行。招募健康的 1 岁儿童,并随机分配接受 GUMLi 或标准牛奶,为期 12 个月,作为完整饮食的一部分。主要结局是通过生物电阻抗法测量的 2 岁时的体脂肪百分比。所有回归模型均根据基线结局和研究中心进行调整。

结果

160 名儿童(每组 80 名)被随机分配,134 名(每组 67 名)被纳入修改后的意向治疗分析。GUMLi 组 12 个月时的平均体脂肪百分比为 23.3%(SD 7.9),牛奶组为 25.7%(SD 7.2)。在调整基线结局和研究地点后,干预组和对照组在 12 个月时的体脂肪百分比估计平均差异为-2.19%(95%CI:-4.24,-0.15;P=0.036)。按方案分析显示出类似的效果(平均差异:-2.09%;95%CI:-4.16,-0.03;P=0.047)。在 12 个月时,GUMLi 组的脂肪量和脂肪量指数均明显低于牛奶组。

结论

在 2 岁时,12 个月内食用蛋白质含量低于牛奶的 GUM 的儿童体脂肪百分比较低。该试验在澳大利亚和新西兰临床试验注册中心注册,注册号为 ACTRN12614000918628。

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