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

Purdue University logo

Purdue University

Status

Completed

Conditions

Healthy

Treatments

Other: Increased Dairy Consumption

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

47 patients

Sex

All

Ages

9 to 14 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

47 participants in 2 patient groups

Increased Dairy Consumption
Experimental group
Description:
Increased Dairy Consumption - Each subject in this arm will receive three additional servings of dairy to consume each day for 18 months.
Treatment:
Other: Increased Dairy Consumption
Control
No Intervention group
Description:
This group will not receive the intervention but will continue their normal diet; they will act as the control.

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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