This trial is active, not recruiting.

Condition healthy
Treatment dairy products
Sponsor Purdue University
Collaborator Indiana University School of Medicine
Start date March 2008
End date June 2012
Trial size 240 participants
Trial identifier NCT00635583, 1482


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Dairy Intervention Each subject in this arm will receive three additional servings of dairy to consume each day for 18 months.
dairy products Prairie Farms Milk
3 additional servings of dairy (two of which must be milk or yogurt) 8 oz milk 6 oz yogurt 1.5 oz cheese
(No Intervention)
This group will not receive the intervention but will continue their normal diet; they will act as the control.

Primary Outcomes

Changes in bone density and geometry as measured with DEXA and pQCT.
time frame: 18 months

Secondary Outcomes

Changes in fat and lean body mass as measured with DEXA.
time frame: 18 months

Eligibility Criteria

Male or female participants from 9 years up to 14 years old.

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.

Additional Information

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
Principal investigator Connie M Weaver, PhD
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by Purdue University.