Substrate Oxidation in Children in Response to High and Low Dairy Intake

Substrate Oxidation in Children in Response to Exercise With High and Low Dairy Intake

The investigators propose a randomized trial comparing higher levels of dairy intake compared to lower levels of dairy intake. Participants will be 20 boys and girls, age 10-13, overweight (>85%) who are currently consuming 1 or fewer servings of dairy per day. Each participant will be randomized to either higher or lower levels of dairy intake. A baseline calorimeter stay will determine 24-hour energy needs. Participants will then receive the diet they have been randomized to receive for 6 days and will then have a second calorimeter stay. During this 2nd stay, each participant will continue to receive the diet they were randomized to receive and will achieve a 300 kcal energy deficit through physical activity. The investigators hypothesize that children who receive a 300 kcal energy deficit from the energy expenditure of exercise and receive 3 to 4 servings of dairy products will show greater increases in fat oxidation compared to children who receive a 300 kcal energy expenditure of exercise and receive 1 or fewer servings of dairy products.

Study Overview

• Status: Completed
• Conditions: Childhood Obesity
• Intervention / Treatment: Dietary supplement: Dairy Products; Dietary supplement: Dairy Servings

Detailed Description

The study objective was to conduct a randomized clinical trial comparing enhanced levels of dairy consumption to lower levels of dairy consumption during an energy deficit resulting from 300 kcal of exercise. Participants were 24 sedentary and overweight boys, 13-15 years of age and girls, 12 to 14 years of age, and consuming 1 or fewer servings of dairy and less than 600 mg calcium per day at baseline. Participants were randomly assigned to either higher or lower dairy for 6 days and then crossed over to the opposite treatment subsequent to 2 weeks of wash out. The investigators provided all meals and snacks for the participants during the higher and lower dairy conditions. During the wash out period, participants were instructed to consume their normal diet as assessed at baseline which consisted of 1 or fewer servings of dairy and less than 600 mg calcium. Participants stayed in the calorimeter at baseline, day 7, and day 28 (end of study), after crossover. The calorimeter measured substrate oxidation under the condition of a 300 kcal energy deficit due to exercise.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lawrence, Kansas, United States, 66045
      • Energy Balance Lab, The University of Kansas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 13 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must be overweight
• and 10-13 years old
• currently consuming 1 or fewer servings of dairy
• less than 600 mg calcium per day

Exclusion Criteria:

• not meeting the above criteria
• must be present for duration of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Recommended dairy diet; Recommended servings of dairy products per day	Dietary supplement: Dairy Products; See the effect dairy product has on fat oxidation in overweight individuals expending the same amount of energy; Other Names: Recommended dairy servings per day
Experimental: Low dairy diet; One or fewer dairy servings per day	Dietary supplement: Dairy Servings; Continue baseline consumption of one or fewer servings of dairy per day; Other Names: One or fewer servings of dairy per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24hr fat oxidation	Fat oxidation over a 24 hr period will be measured using whole room indirect calorimetry.	24 hrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24hr energy expenditure	Energy Expenditure over a 24 hr period will be measured using whole room indirect calorimetry.	baseline, 7 days after each diet

Collaborators and Investigators

• Sponsor: University of Kansas
• Collaborators: Dairy Management Inc.
• Investigators: Principal Investigator: Joseph E Donnelly, EdD, Univesity of Kansas

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): December 1, 2005
• Study Completion (Actual): December 1, 2005

Study Registration Dates

• First Submitted: August 10, 2012
• First Submitted That Met QC Criteria: August 13, 2012
• First Posted (Estimate): August 14, 2012

Study Record Updates

• Last Update Posted (Estimate): August 14, 2012
• Last Update Submitted That Met QC Criteria: August 13, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: obesity; Dairy
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: HSCL15253; DMI1096 (Other Grant/Funding Number: Dairy Management Inc.)