Substrate Oxidation in Children in Response to High and Low Dairy Intake
Primary Purpose
Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dairy Products
Dairy Servings
Sponsored by
About this trial
This is an interventional prevention trial for Childhood Obesity focused on measuring Dairy, obesity
Eligibility Criteria
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
Sites / Locations
- Energy Balance Lab, The University of Kansas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Recommended dairy diet
Low dairy diet
Arm Description
Recommended servings of dairy products per day
One or fewer dairy servings per day
Outcomes
Primary Outcome Measures
24hr fat oxidation
Fat oxidation over a 24 hr period will be measured using whole room indirect calorimetry.
Secondary Outcome Measures
24hr energy expenditure
Energy Expenditure over a 24 hr period will be measured using whole room indirect calorimetry.
Full Information
NCT ID
NCT01664702
First Posted
August 10, 2012
Last Updated
August 13, 2012
Sponsor
University of Kansas
Collaborators
Dairy Management Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01664702
Brief Title
Substrate Oxidation in Children in Response to High and Low Dairy Intake
Official Title
Substrate Oxidation in Children in Response to Exercise With High and Low Dairy Intake
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas
Collaborators
Dairy Management Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Dairy, obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Recommended dairy diet
Arm Type
Experimental
Arm Description
Recommended servings of dairy products per day
Arm Title
Low dairy diet
Arm Type
Experimental
Arm Description
One or fewer dairy servings per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Dairy Products
Other Intervention Name(s)
Recommended dairy servings per day
Intervention Description
See the effect dairy product has on fat oxidation in overweight individuals expending the same amount of energy
Intervention Type
Dietary Supplement
Intervention Name(s)
Dairy Servings
Other Intervention Name(s)
One or fewer servings of dairy per day
Intervention Description
Continue baseline consumption of one or fewer servings of dairy per day
Primary Outcome Measure Information:
Title
24hr fat oxidation
Description
Fat oxidation over a 24 hr period will be measured using whole room indirect calorimetry.
Time Frame
24 hrs
Secondary Outcome Measure Information:
Title
24hr energy expenditure
Description
Energy Expenditure over a 24 hr period will be measured using whole room indirect calorimetry.
Time Frame
baseline, 7 days after each diet
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph E Donnelly, EdD
Organizational Affiliation
Univesity of Kansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Energy Balance Lab, The University of Kansas
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66045
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Substrate Oxidation in Children in Response to High and Low Dairy Intake
We'll reach out to this number within 24 hrs