Clinical trial NCT03602144: Breakfast and Muscle Health in Children
Official title: Breakfast, Energy Metabolism, and Skeletal Muscle Health in Obese Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight Changes
Body Composition
Muscle Mass
Energy Expenditure
Nutrition
Lead sponsor: University of Arkansas, Fayetteville
Sponsor class: OTHER
Collaborators: name: University of Arkansas
First posted: 2018-07-26
Enrollment: 88
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: One in every three children ages 2-19 years is overweight or obese. Although multifactorial in nature, obesity is primarily attributed to a mismatch between energy intake and energy expenditure (EE). Daily EE (DEE) can be partitioned between resting metabolic rate (RMR), EE associated with physical activity, and the thermic effect of food (TEF). RMR corresponds to the energy needed to sustain the body functions at rest and is also related to body composition (i.e., ratio of skeletal muscle mass to fat mass). Skeletal muscle mass is a large contributor to RMR; the more skeletal muscle mass, the higher the RMR (i.e., more energy expended at rest). In addition, muscle plays a central role in whole body protein metabolism and disrupted muscle metabolism is associated with the development of many common chronic diseases associated with obesity such as type 2 diabetes and cardiovascular disease. Although the contribution of disrupted muscle metabolism to chronic disease is well-established in older adults, the potential impact in children is unknown. The overall objective for this primary project application is to determine the role of breakfast protein consumption in improving energy metabolism, energy balance and skeletal muscle health in obese, school-aged children.


Eligibility criteria: Inclusion Criteria:

* Resides within Northwest Arkansas
* Age 8-12 years old
* BMI \>5th percentile
* All ethnicities

Exclusion Criteria:

* Food allergies
* Dietary restrictions
* Regularly skip breakfast (\> 5 times per week)
* Prescription medications
* Claustrophobic
* Fear of needles
* Classified as a picky eater by parent/guardian

Primary outcomes:
measure: Whole body energy expenditure (WBEE)
timeFrame: WBEE will be measured as the change between WBEE during day 1 and day 42 of the intervention.
Secondary outcomes:
measure: Appetite (VAS)
timeFrame: VAS will be measured on day 1 and day 42.
measure: Glycemic Response
timeFrame: Glycemic response will be measured on day 1 and day 42.
measure: Muscle mass
timeFrame: Change in muscle mass will be determined by the difference in muscle mass between day 1 and day 42.
measure: Muscle fractional synthesis rate (FSR)
timeFrame: FSR will be determined as the change between baseline (day 0) and day 42.
measure: Whole body protein turnover (WPT)
timeFrame: Change in WPT will be determined by the difference in WPT between day 1 and day 42.
measure: Resting energy expenditure (REE)
timeFrame: Change in REE will be determined by the difference in REE between day 1 and day 42.
measure: Body composition
timeFrame: Change in body composition will be determined by the difference in body composition between day 1 and day 42.
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: University of Arkansas
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Jamie I Baum, PhD
role: PRINCIPAL_INVESTIGATOR
References: