Substrate Oxidation in Children in Response to High and Low Dairy Intake
2 other identifiers
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 10, 2012
CompletedFirst Posted
Study publicly available on registry
August 14, 2012
CompletedAugust 14, 2012
August 1, 2012
11 months
August 10, 2012
August 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
24hr fat oxidation
Fat oxidation over a 24 hr period will be measured using whole room indirect calorimetry.
24 hrs
Secondary Outcomes (1)
24hr energy expenditure
baseline, 7 days after each diet
Study Arms (2)
Recommended dairy diet
EXPERIMENTALRecommended servings of dairy products per day
Low dairy diet
EXPERIMENTALOne or fewer dairy servings per day
Interventions
See the effect dairy product has on fat oxidation in overweight individuals expending the same amount of energy
Continue baseline consumption of one or fewer servings of dairy per day
Eligibility Criteria
You may qualify if:
- Must be overweight
- and 10-13 years old
- currently consuming 1 or fewer servings of dairy
- less than 600 mg calcium per day
You may not qualify if:
- not meeting the above criteria
- must be present for duration of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Kansaslead
- Dairy Management Inc.collaborator
Study Sites (1)
Energy Balance Lab, The University of Kansas
Lawrence, Kansas, 66045, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph E Donnelly, EdD
Univesity of Kansas
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 10, 2012
First Posted
August 14, 2012
Study Start
January 1, 2005
Primary Completion
December 1, 2005
Study Completion
December 1, 2005
Last Updated
August 14, 2012
Record last verified: 2012-08