B3: The Effect of Dairy on Bone Mass and Body Composition in 4th-8th Grade Boys and Girls

Sponsor

Purdue University (Other)

Overall Status

Completed

CT.gov ID

NCT00635583

Collaborator

Indiana University School of Medicine (Other), Dairy Management Inc. (Industry)

Enrollment

Locations

Arms

Actual Duration (Months)

23.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Increased Dairy Consumption	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: Increased Dairy Consumption 3 additional servings of dairy (two of which must be milk or yogurt) 8 oz milk 6 oz yogurt 1.5 oz cheese Other Names: Prairie Farms Milk Prairie Farms Yogurt
No Intervention: Control This group will not receive the intervention but will continue their normal diet; they will act as the control.

Arm

Intervention/Treatment

Experimental: 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.

Other: Increased Dairy Consumption

3 additional servings of dairy (two of which must be milk or yogurt) 8 oz milk 6 oz yogurt 1.5 oz cheese

Other Names:

Prairie Farms Milk

Prairie Farms Yogurt

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

Changes in bone density and geometry as measured with DEXA and pQCT. [18 months]

Secondary Outcome Measures

Changes in fat and lean body mass as measured with DEXA. [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.