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临床试验/NCT07492095
NCT07492095招募中不适用

Determination of Leucine Requirements in Healthy School-Age Children Using the Indicator Amino Acid Oxidation Method

University of British Columbia1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2026年6月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
7
试验地点
1
主要终点
Carbon-13 Oxidation

研究概览

简要总结

Leucine is an essential amino acid, which serves a special purpose of signaling cell growth in muscle in addition to making up protein. Essential amino acids like leucine need to be eaten every day from our foods like meat, dairy, eggs, beans, and nuts, as they cannot be made by our bodies. The current recommendation for leucine in the diet of school-age children are based upon adult needs. This study will measure the leucine requirement in children aged 6-10 years old using an non-invasive technique with special diets, safe stable isotopes, and simple breath collections. Creating guidelines based on measured requirements for leucine in this age group is essential for supporting optimal growth in healthy children.

详细描述

Purpose:

- The purpose of this study is to determine the requirement of the essential amino acid leucine, in school-aged children (6-10 years old), with the minimally invasive indicator amino acid oxidation (IAAO) protocol.

Hypothesis:

- The leucine requirement for healthy school-age children is higher than current 2005 recommendation of 40-49 mg/kg/d when measured using the IAAO method.

Justification:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy children
  • Aged 6 to 10 years at enrollment
  • Body weight between the 3rd and 85th percentile according to WHO Child Growth Standards
  • Assent from the child and written informed consent from parent(s) and/or legal guardian(s)

排除标准

  • Diagnosis of any acute or chronic medical condition
  • Current use of prescription medication that may affect protein or energy metabolism
  • Recent weight loss
  • Recent illness (fever, vomiting, severe runny nose within the past 5 days)
  • Inability to comply with study procedures

结局指标

主要结局

Carbon-13 Oxidation

时间窗: 8 hours (1 study day)

9 breath samples will be collected during the study day, to measure the rate of oxidation of tracer phenylalanine in the expired breath.

次要结局

  • Urinary L-[1-13C] Phenylalanine Flux(8 hours (1 study day))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rajavel Elango, PhD

Principal Investigator

University of British Columbia

研究点 (1)

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