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Completed

NCT Number: NCT00635583

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

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.

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Key information

Conditions

Healthy

Age range

9 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University School of Medicine, Indianapolis, Indiana, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Increased Dairy Consumption

Other

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

Primary outcomes

  1. Changes in bone density and geometry as measured with DEXA and pQCT.

    Time frame: 18 months

Secondary outcomes

  1. Changes in fat and lean body mass as measured with DEXA.

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

  • Dairy Management Inc.
  • Indiana University

Registry information

Official study 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

Acronym: B3

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Mar 13, 2008
Registry last updated
May 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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