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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2012-06-30

Brief Summary

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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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Bone Status

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Increased Dairy Consumption

Intervention Type OTHER

3 additional servings of dairy (two of which must be milk or yogurt)

* 8 oz milk
* 6 oz yogurt
* 1.5 oz cheese

Control

This group will not receive the intervention but will continue their normal diet; they will act as the control.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Increased 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

Intervention Type OTHER

Other Intervention Names

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Prairie Farms Milk Prairie Farms Yogurt

Eligibility Criteria

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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.

Minimum Eligible Age

9 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes