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临床试验/NCT03602144
NCT03602144已完成不适用

Breakfast, Energy Metabolism, and Skeletal Muscle Health in Obese Children

University of Arkansas, Fayetteville2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2018年6月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
88
试验地点
2
主要终点
Whole body energy expenditure (WBEE)

研究概览

简要总结

One in every three children ages 2-19 years is overweight or obese. Although multifactorial in nature, obesity is primarily attributed to a mismatch between energy intake and energy expenditure (EE). Daily EE (DEE) can be partitioned between resting metabolic rate (RMR), EE associated with physical activity, and the thermic effect of food (TEF). RMR corresponds to the energy needed to sustain the body functions at rest and is also related to body composition (i.e., ratio of skeletal muscle mass to fat mass). Skeletal muscle mass is a large contributor to RMR; the more skeletal muscle mass, the higher the RMR (i.e., more energy expended at rest). In addition, muscle plays a central role in whole body protein metabolism and disrupted muscle metabolism is associated with the development of many common chronic diseases associated with obesity such as type 2 diabetes and cardiovascular disease. Although the contribution of disrupted muscle metabolism to chronic disease is well-established in older adults, the potential impact in children is unknown. The overall objective for this primary project application is to determine the role of breakfast protein consumption in improving energy metabolism, energy balance and skeletal muscle health in obese, school-aged children.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
7 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Resides within Northwest Arkansas
  • Age 8-12 years old
  • BMI >5th percentile
  • All ethnicities

排除标准

  • Food allergies
  • Dietary restrictions
  • Regularly skip breakfast (> 5 times per week)
  • Prescription medications
  • Claustrophobic
  • Fear of needles
  • Classified as a picky eater by parent/guardian

结局指标

主要结局

Whole body energy expenditure (WBEE)

时间窗: WBEE will be measured as the change between WBEE during day 1 and day 42 of the intervention.

WBEE will be measured using doubly labeled water.

次要结局

  • Muscle fractional synthesis rate (FSR)(FSR will be determined as the change between baseline (day 0) and day 42.)
  • Appetite (VAS)(VAS will be measured on day 1 and day 42.)
  • Glycemic Response(Glycemic response will be measured on day 1 and day 42.)
  • Muscle mass(Change in muscle mass will be determined by the difference in muscle mass between day 1 and day 42.)
  • Whole body protein turnover (WPT)(Change in WPT will be determined by the difference in WPT between day 1 and day 42.)
  • Resting energy expenditure (REE)(Change in REE will be determined by the difference in REE between day 1 and day 42.)
  • Body composition(Change in body composition will be determined by the difference in body composition between day 1 and day 42.)

研究者

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

Jamie Baum

Assistant Professor

University of Arkansas, Fayetteville

研究点 (2)

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