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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Increased Dairy Consumption

• Registration Number: NCT00635583
• Lead Sponsor: Purdue University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-06
• Study First Submitted QC: 2008-03-12
• Study First Posted: 2008-03-13
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Increased Dairy Consumption	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.

Primary Outcome Measures

Name	Time	Method
Changes in bone density and geometry as measured with DEXA and pQCT.	18 months

Secondary Outcome Measures

Name	Time	Method
Changes in fat and lean body mass as measured with DEXA.	18 months

Trial Locations

Locations (2)

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States

Purdue University; 🇺🇸 West Lafayette, Indiana, United States