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临床试验/NCT00378820
NCT00378820Unknown不适用

The Effect of Whey and Casein With and Without Milk Minerals on IGFs in Prepubertal Boys

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2004年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
IGF-I

研究概览

简要总结

It is not clear which milk compounds are responsible for the growth stimulation. Through short term intervention studies in prepubertal children, we will test the effects of whey, casein, and milk minerals (especially Ca/P). Outcomes will be IGF-I, IGFBP-3, p-amino acids, oral glucose tolerance test (insulin, glucose, GLP-1 and 2, C-peptide, proinsulin) and markers for bone turn-over in blood and urine (s-osteocalcin, s-bone alkaline phosphatase, urine Dpyr, Ntx) as well as blood pressure.

详细描述

Milk has evolved to support high growth velocity in newborns and observational and intervention studies suggest that milk has special growth stimulating properties especially regarding body size, bone mass and gut. We have previously shown that a one week high-dose intervention with milk, but not meat, increased fasting IGF-I and insulin levels in prepubertal boys. It is not clear which milk compounds are responsible for the growth stimulation. Through short term intervention studies in prepubertal children, we will test the effects of whey, casein, and milk minerals (especially Ca/P). Outcomes will be IGF-I, IGFBP-3, p-amino acids, oral glucose tolerance test (insulin, glucose, GLP-1 and 2, C-peptide, proinsulin) and markers for bone turn-over in blood and urine (s-osteocalcin, s-bone alkaline phosphatase, urine Dpyr, Ntx) as well as blood pressure. Exploring the growth stimulating effects of these milk components will improve the understanding of dietary effects on growth and bone metabolism, and will be valuable for the diary industry developing dietary products supporting growth e.g. infant formula, products for clinical nutrition and milk based products for nutritional rehabilitation of malnourished children in developing countries.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Double

入排标准

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

入选标准

  • habital milk intake:200 - 500 mL/d

排除标准

  • chronic illnesses
  • children who suffer from any condition likely to affect their protein metabolism or growth

结局指标

主要结局

IGF-I

IGFBP-3

Insulin

Glucose

次要结局

  • Blood Pressure
  • Body Composition
  • Adiponectin
  • Osteocalcin
  • BAP
  • Urea Nitrogen
  • Amino Acids
  • Ghrelin
  • C-peptide
  • OGGT
  • Leptin
  • CTX

研究者

申办方类型
Other

研究点 (2)

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