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临床试验/NCT04819308
NCT04819308进行中(未招募)不适用

Substrate Utilization in Pre-pubertal Children During Submaximal Exercise and Rest ("SUPER Kids")

Arkansas Children's Hospital Research Institute1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2021年3月18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
95
试验地点
1
主要终点
Substrate Oxidation

研究概览

简要总结

Children who have previously participated in the study "MI Energy" will be invited to participate in "SUPER kids". Investigators want to better understand differences in nutrient use (e.g., fatty acid and carbohydrate) during rest and exercise in children of varying body types and activity levels.

详细描述

We will examine fatty acid oxidation (FAO) and carbohydrate (CHO) oxidation at rest and during exercise in children of all body types and activity levels.

Children 8-11 years old who have done the "MI Energy" study will participate. Up to 80 children will be recruited to participate in this study at Arkansas Children's Nutrition Center (ACNC).

They will be asked to attend three study visits (baseline, and two exercise visits). For the exercise visits, they will follow a diet plan and be encouraged to avoid certain foods and activities.

Children will do two testing days with the following measures:

  • Urine (pee) will be collected
  • Body weight and height
  • Exercise test on the bike - children will ride a stationary bike at a set intensity and at an intensity relative to their previous bike test during the study "MI Energy". The order in which they bike will be random. Before and during biking, children will wear a mask that will measure the gases in their breath and a monitor that will measure heart rate.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

年龄范围
8 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Boys or girls
  • Ages 8-11 years
  • All races
  • All ethnicities
  • Children who completed a dual-energy x-ray absorptiometry (DXA) scan during "MI Energy" (IRB Protocol: 260376)
  • Children who completed a fitness test during "MI Energy" (IRB Protocol: 260376) and achieved peak oxygen uptake (VO2 peak)
  • All fitness levels [VO2 peak already determined under "MI Energy" (IRB Protocol: 260376)]
  • Children whose parents consented to the following in the "MI Energy" (IRB Protocol: 260376) study:
  • A) be contacted about future follow-up studies to "MI Energy", and having the data that is collected about their child in "MI Energy" being used also in these follow-up studies; and B) information collected in the "MI Energy" study may be used in future research related to bioenergetics (for example, blood cell mitochondria function), nutrition, obesity, cardiovascular health, or development; and C) any biological samples collected in the "MI Energy" study may be used in future research related to bioenergetics (for example, blood cell mitochondria function), nutrition, obesity, cardiovascular health, or development.

排除标准

  • Participants who have been excluded from participation in the study "MI Energy" (IRB Protocol: 260376).
  • Participants whose parents report any change in medical history that may potentially affect participation and/or study outcomes as determined by PI.
  • Participants whose parents report food allergies or intolerances to nuts, wheat, dairy, or eggs.
  • Participants whose parents report unwillingness to follow dietary standardization.

结局指标

主要结局

Substrate Oxidation

时间窗: 24 months

Carbohydrate oxidation and fatty acid oxidation quantified using breath samples measured by indirect calorimetry

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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