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临床试验/NCT00635583
NCT00635583已完成不适用

Influence of Dairy on Bone Accrual and Bone Size and Fat and Lean Mass in Early Pubertal Overweight vs. Healthy-weight Boys and Girls

Purdue University4 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2008年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
47
试验地点
4
主要终点
Changes in bone density and geometry as measured with DEXA and pQCT.

研究概览

简要总结

Building stronger bones during pubertal growth could reduce lifelong fracture risk. This project is an 18 month dairy intervention study for overweight and healthy weight 4th-8th grade boys and girls. Half of the girls will receive dairy products to add to their habitual diet (milk, yogurt, and cheese) to equal three products per day, while the other half will remain on their normal diet. All participants will attend four study visits, each 6 months apart. At these visits height, weight, bone density and geometry, and fat and lean mass will be measured. This study aims to show that meeting calcium requirements by eating dairy products builds bigger, stronger bones, and that this effect may be enhanced in overweight boys and girls. The effect of the dairy intervention on body fat, lean mass, and weight, as well as the mechanisms and predictors of changes in bone mass and size and body composition will also be evaluated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Males and females in 4th-8th grade
  • Generally healthy
  • BMI percentile 5-70% for age or >85% for age
  • Baseline calcium intake less than or equal to 800mg/d

排除标准

  • History of any illness known to affect bone mass accrual (diabetes, inflammatory bowel disease, childhood malignancy).
  • A broken bone in the last six months.
  • Consume more than 800 mg Calcium/d.

研究组 & 干预措施

Increased Dairy Consumption

Experimental

Increased Dairy Consumption - Each subject in this arm will receive three additional servings of dairy to consume each day for 18 months.

干预措施: Increased Dairy Consumption (Other)

Control

No Intervention

This group will not receive the intervention but will continue their normal diet; they will act as the control.

结局指标

主要结局

Changes in bone density and geometry as measured with DEXA and pQCT.

时间窗: 18 months

次要结局

  • Changes in fat and lean body mass as measured with DEXA.(18 months)

研究者

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

Berdine Martin

Research Scientist, Nutrition Science

Purdue University

研究点 (4)

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