跳至主要内容
临床试验/NCT02971046
NCT02971046进行中(未招募)不适用

Glutathione (GSH) Synthesis in Response to Graded Protein Intakes: a Functional Measure of Protein Requirement in Healthy School-aged Children and Healthy Young and Old Adults

The Hospital for Sick Children2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
55
试验地点
2
主要终点
Erythrocyte GSH Fractional synthesis rates

研究概览

简要总结

To measure the fractional and absolute synthesis rates of GSH, an antioxidant that protects cells from damage, in the erythrocytes of healthy school-aged children, young adults and old adults in response to graded intakes of protein in order to determine if increasing the protein intake above the current recommended DRI produces increases in the GSH synthesis rates in erythrocytes of these individuals. Participants will consume specially formulated diets with varying protein levels.

详细描述

The current dietary reference intake (DRI) recommendations for protein in children (6-11 years old) and adults (>19 years old) are based on nitrogen balance data and set at a mean (EAR) of 0.76 and 0.66 g/kg/day respectively and population safe (RDA) recommendation of 0.95 and 0.80 g/kg/day respectively. Using the indicator amino oxidation (IAAO) method we estimated higher protein requirements in these populations. This suggests that current recommendations are underestimated. Studies in adults have shown that protein recommendation set on the basis of nitrogen balance data, while sufficient to maintain nitrogen balance, does not maintain GSH status.

Glutathione (GSH) is most important intracellular antioxidant and scavenger and its deficiency has been shown to compromise recovery in acute as well as chronic stressors. Deficiency of GSH results when protein and/or cysteine intake is inadequate. Inadequate protein intake in children not only compromises growth, but could increase susceptibility to, and compromise recovery from regular childhood illness. Similarly, in young and older adults' inadequate intakes may result in increased oxidative stress and compromised immune function. Measurement of GSH synthesis provides a functional method whereby the current protein recommendation can be tested against higher estimates derived using the IAAO method. The purpose of this study therefore is to measure GSH synthesis in healthy school aged children (6-11 years), and healthy young (19 - 40 years) and old (60 - 90 years) adults in response to current recommended protein intakes and in response to protein requirement estimates derived using the IAAO method.

In healthy school-aged children, each level of protein will be studied over three days. For two days (adaptation days), participants will eat some low protein foods plus a milkshake drink. On the study day, participants will consume 8 hourly protein drinks and special cookies at SickKids. In healthy young and old adults, each level of protein will be studied over three days. For two days (adaptation days), young adults will eat some low protein foods plus a milkshake drink. On the one study day, young adults will consume 10 hourly milkshake diets at SickKids. In old adults, each level of protein will be studied over four days. For three days (adaptation days), old adults will eat some low protein foods plus a milkshake drink. On the one study day, old adults will consume 10 hourly milkshake diets at SickKids.

研究设计

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

入排标准

年龄范围
6 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Erythrocyte GSH Fractional synthesis rates

时间窗: up to 24 months

To measure the fractional synthesis rates of GSH in the erythrocytes of healthy school-aged children and healthy young and old adults in response to graded intakes of protein.

次要结局

  • Erythrocyte GSH absolute synthesis(up to 24 months)

研究者

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

Glenda Courtney-Martin

Academic &Clinical Specialist, Project Investigator

The Hospital for Sick Children

研究点 (2)

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