A six-month randomized controlled pilot study evaluating the effects of an oral nutrition supplement on children's growth patterns

Q3 Nursing

Clinical Nutrition Open Science Pub Date : 2025-02-01 DOI:10.1016/j.nutos.2024.11.006

Robert Frument , Ceci Mao , Becca Li , Clara Chan , Diana Pozo , John Ademola , Michael Milobsky

{"title":"A six-month randomized controlled pilot study evaluating the effects of an oral nutrition supplement on children's growth patterns","authors":"Robert Frument , Ceci Mao , Becca Li , Clara Chan , Diana Pozo , John Ademola , Michael Milobsky","doi":"10.1016/j.nutos.2024.11.006","DOIUrl":null,"url":null,"abstract":"<div><h3>Background and aims</h3><div>Pilot study to evaluate the effect of oral nutrition supplementation (ONS) among children and adolescents.</div></div><div><h3>Methods</h3><div>A prospective, randomized trial of nutritional supplementation was conducted among 32 children and adolescents 4–17 years of age. Change in height and weight standard deviation score (SDS) as well as measures of body composition were measured 3 times over a six month study period. Participants in the treatment arm were given ONS to take once a day, 5 days a week; the controls continued their usual diet. Three study visits were conducted to collect measurements for all subjects: baseline, 3 months and 6 months. Univariate, bivariate and multivariate analyses were conducted to estimate the effect of the powder supplement on height velocity as measured by standard deviation score (SDS) as well as static body composition measurements (lean body mass, fat-free mass, body mass index (BMI)) and collagen X concentration in the urine.</div></div><div><h3>Results</h3><div>The mean change in height SDS increased in both the treatment and control groups, but only the treatment group achieved statistical significance (SDS 0.09, 95% Confidence Interval (CI) 0.04, 0.15, p=0.0028). The mean increase in height in the treatment group was 2.94 cm (95% CI 2.22, 3.66) compared to 2.23 cm (95% CI 1.34, 3.12) in the control group. Changes in the secondary outcome measures (BMI, fat mass, lean mass and collagen X) did not reach statistical significance. The most parsimonious linear regression model (p<0.0001, Adj R-squared 0.6950) suggests that the ONS afforded a 0.281 cm growth advantage when controlling for baseline age, sex, height, and collagen X.</div></div><div><h3>Conclusions</h3><div>The change in height SDS was statistically significant only in the treatment group (p=0.0028). While both groups grew, as expected, the multivariate model suggests an advantage for the treatment group when controlling for baseline characteristics.</div></div><div><h3>Clinical trial registry number</h3><div><span><span>https://clinicaltrials.gov/study/NCT06329388</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":36134,"journal":{"name":"Clinical Nutrition Open Science","volume":"59 ","pages":"Pages 17-30"},"PeriodicalIF":0.0000,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Nutrition Open Science","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2667268524001189","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Nursing","Score":null,"Total":0}

引用次数: 0

Abstract

Background and aims

Pilot study to evaluate the effect of oral nutrition supplementation (ONS) among children and adolescents.

Methods

A prospective, randomized trial of nutritional supplementation was conducted among 32 children and adolescents 4–17 years of age. Change in height and weight standard deviation score (SDS) as well as measures of body composition were measured 3 times over a six month study period. Participants in the treatment arm were given ONS to take once a day, 5 days a week; the controls continued their usual diet. Three study visits were conducted to collect measurements for all subjects: baseline, 3 months and 6 months. Univariate, bivariate and multivariate analyses were conducted to estimate the effect of the powder supplement on height velocity as measured by standard deviation score (SDS) as well as static body composition measurements (lean body mass, fat-free mass, body mass index (BMI)) and collagen X concentration in the urine.

Results

The mean change in height SDS increased in both the treatment and control groups, but only the treatment group achieved statistical significance (SDS 0.09, 95% Confidence Interval (CI) 0.04, 0.15, p=0.0028). The mean increase in height in the treatment group was 2.94 cm (95% CI 2.22, 3.66) compared to 2.23 cm (95% CI 1.34, 3.12) in the control group. Changes in the secondary outcome measures (BMI, fat mass, lean mass and collagen X) did not reach statistical significance. The most parsimonious linear regression model (p<0.0001, Adj R-squared 0.6950) suggests that the ONS afforded a 0.281 cm growth advantage when controlling for baseline age, sex, height, and collagen X.

Conclusions

The change in height SDS was statistically significant only in the treatment group (p=0.0028). While both groups grew, as expected, the multivariate model suggests an advantage for the treatment group when controlling for baseline characteristics.

Clinical trial registry number

https://clinicaltrials.gov/study/NCT06329388.

查看原文本刊更多论文

一项为期六个月的随机对照试验，评估口服营养补充剂对儿童生长模式的影响

背景与目的本研究旨在评价儿童和青少年口服营养补充剂（ONS）的效果。方法对32名4-17岁的儿童和青少年进行前瞻性、随机的营养补充试验。在6个月的研究期间，测量了3次身高和体重标准差（SDS）的变化以及身体成分的测量。治疗组的参与者给予ONS，每天一次，每周5天；对照组继续他们平常的饮食。进行了三次研究访问以收集所有受试者的测量数据：基线、3个月和6个月。通过单因素、双因素和多因素分析来估计粉末补充剂对身高速度的影响，这些影响是通过标准差评分（SDS）以及静态身体成分测量（瘦体重、无脂体重、体重指数（BMI））和尿液中X胶原蛋白浓度来测量的。结果治疗组和对照组的身高SDS的平均变化均有所增加，但只有治疗组有统计学意义（SDS 0.09, 95%可信区间（CI） 0.04, 0.15, p=0.0028）。治疗组的平均身高增加2.94 cm (95% CI 2.22, 3.66)，对照组的平均身高增加2.23 cm （95% CI 1.34, 3.12）。次要结局指标（BMI、脂肪质量、瘦质量和胶原蛋白X）的变化没有统计学意义。最简洁的线性回归模型（p<0.0001， Adj r平方0.6950）表明，在控制基线年龄、性别、身高和胶原蛋白x时，ONS提供了0.281 cm的生长优势。结论高度SDS的变化仅在治疗组有统计学意义（p=0.0028）。正如预期的那样，两组都有所增长，但多变量模型表明，在控制基线特征时，治疗组具有优势。临床试验注册编号https://clinicaltrials.gov/study/NCT06329388。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊