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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00635583

Acronym

Enrollment

Registered

2008-03-13

Start date

2008-03-31

Completion date

2012-06-30

Last updated

2018-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Bone, Dairy Intervention, Girls, Boys, Calcium, Bone Mineralization, Peak Bone Mass, Bone and Bones, Female, Male, Adolescent, Healthy

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.

Interventions

OTHERIncreased 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

9 Years to 14 Years

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.

Design outcomes

Primary

Measure	Time frame
Changes in bone density and geometry as measured with DEXA and pQCT.	18 months

Secondary

Measure	Time frame
Changes in fat and lean body mass as measured with DEXA.	18 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026