Influence of Dairy on Bone Accrual and Bone Size and Fat and Lean Mass in Early Pubertal Overweight vs. Healthy-weight Boys and Girls
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
- 是
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
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
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
Berdine Martin
Research Scientist, Nutrition Science
Purdue University
