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

NCT00635583 | Completed

• 1 other identifier: 1482
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  18 months

Secondary Outcomes (1)

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

  18 months

Study Arms (2)

Increased Dairy Consumption

EXPERIMENTAL

Increased Dairy Consumption - Each subject in this arm will receive three additional servings of dairy to consume each day for 18 months.

Other: Increased Dairy Consumption

Control

NO INTERVENTION

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

Interventions

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

Also known as: Prairie Farms Milk, Prairie Farms Yogurt

Increased Dairy Consumption

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Purdue University: lead
• Indiana University School of Medicine: collaborator
• Dairy Management Inc.: collaborator

Study Sites (2)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (1)

• Vogel KA, Martin BR, McCabe LD, Peacock M, Warden SJ, McCabe GP, Weaver CM. The effect of dairy intake on bone mass and body composition in early pubertal girls and boys: a randomized controlled trial. Am J Clin Nutr. 2017 May;105(5):1214-1229. doi: 10.3945/ajcn.116.140418. Epub 2017 Mar 22.

  PMID: 28330908 DERIVED

Study Officials

• Connie M Weaver, PhD

  Purdue University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist, Nutrition Science

Study Record Dates

• First Submitted: March 6, 2008
• First Posted: March 13, 2008
• Study Start: March 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 9, 2018

Record last verified: 2018-05

Locations

US (2)