The Effect of Dairy on Bone Mass and Body Composition in 4th-8th Grade Boys and Girls

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Other: Increased Dairy Consumption


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Increased Dairy Consumption<br>Increased Dairy Consumption - Each subject in this arm will receive three additional servings of dairy to consume each day for 18 months. | Other: Increased Dairy Consumption<br>* 3 additional servings of dairy (two of which must be milk or yogurt) 8 oz milk 6 oz yogurt 1.5 oz cheese<br>* Other names: Prairie Farms Yogurt;|
| No Intervention: Control<br>This group will not receive the intervention but will continue their normal diet; they will act as the control. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in bone density and geometry as measured with DEXA and pQCT. |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in fat and lean body mass as measured with DEXA. |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone, Dairy Intervention, Girls, Boys, Calcium, Bone Mineralization, Peak Bone Mass, Bone and Bones, Female, Male, Adolescent, Healthy