Calcium, Dairy, and Body Fat in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Energy balance will be calculated by quantitating the kilocalories represented by the following components: dietary intake, excreta, physical activity, resting energy expenditure, thermic effect of food, and thermogenesis.
研究概览
简要总结
Lifestyle choices,including diet,are conducive to healthy body weights in children. Dairy products and calcium supplementation have been associated with moderation of body weight and body fat. This study was designed to test the following hypotheses with overweight and obese adolescents consuming a controlled diet:
- Dietary calcium supplementation as calcium carbonate or dairy calcium modulates energy balance in adolescents.
- Increased calcium in the diet of adolescents will increase fecal fat excretion and thereby decrease fat absorption.
- Calcium and dairy product supplementation will increase lipid oxidation resulting in an increase in energy expenditure.
详细描述
Subjects will consume a controlled diet containing 800 mg calcium for two three week periods. During one period they will also receive a frozen ice cream like product (smoothie) twice a day based on soy protein that contains no additional calcium. During the other period they will receive a similar product twice a day based on either dairy protein that contains 650 mg calcium or based on soy protein that contains 650 mg calcium as calcium carbonate
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over weight (>85th percentile BMI for age)
排除标准
- •> 180% of ideal body weight for height
- •Malabsorptive disorders
- •Bone disease
- •Liver disease
- •Kidney disease
- •Smoking or illegal drugs
- •Oral contraceptives
- •Pregnancy
- •Medications that influence calcium metabolism
结局指标
主要结局
Energy balance will be calculated by quantitating the kilocalories represented by the following components: dietary intake, excreta, physical activity, resting energy expenditure, thermic effect of food, and thermogenesis.
时间窗: After equilibration on a controlled diet for one week, measurements will be taken over an additional two week period.
次要结局
- Serum biochemical measures of calcium metabolism (PTH, Vitamin D, and calcium)(Serial meausures over a 10 hour period following a meal containing calcium from the placebo, dairy or calcium carbonate supplement)
- Calcium retention(Two weeks on a controlled diet following one week of equilibration on the same diet)