Breakfast and Muscle Health in Children

Study Overview
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Brief Summary
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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.

Official Title
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Breakfast, Energy Metabolism, and Skeletal Muscle Health in Obese Children

Conditions
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Body Weight Changes, Body Composition, Muscle Mass, Energy Expenditure, Nutrition

Intervention / Treatment
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* Other: Carbohydrate
* Other: Protein


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Carbohydrate<br>Participants will receive a carbohydrate-based smoothie every morning for 6 weeks (42 days). | Other: Carbohydrate<br>* Participants will receive a carbohydrate-based breakfast beverage everyone morning for 42 days.<br>|
| Experimental: Protein<br>Participants will receive a protein-based smoothie every morning for 6 weeks (42 days). | Other: Protein<br>* Participants will receive a protein-based breakfast beverage everyone morning for 42 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole body energy expenditure (WBEE) | WBEE will be measured using doubly labeled water. | WBEE will be measured as the change between WBEE during day 1 and day 42 of the intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetite (VAS) | Appetite response to test beverages will be measured using visual analog scales. Appetite and palatability were assessed using a traditional 100-mm visual analog scale (VAS) [33] with opposing anchors (e.g., extremely hungry or not hungry at all) at time points 0, 15, 30, 60, 90, and 120 min. Questions consisted of: how hungry do you feel at this moment, how full do you feel at this moment, how strong is your desire to eat this moment and how much food do you think you can eat at this moment. A higher number is associated with increased hunger. | VAS will be measured on day 1 and day 42. | 
| Glycemic Response | Glucose and insulin will be measured using commercially available kits. | Glycemic response will be measured on day 1 and day 42. | 
| Muscle mass | Muscle mass will be measured using stable isotope-labeled creatine. | Change in muscle mass will be determined by the difference in muscle mass between day 1 and day 42. | 
| Muscle fractional synthesis rate (FSR) | FSR will be measured using deuterated water and markers of muscle health in plasma. | FSR will be determined as the change between baseline (day 0) and day 42. | 
| Whole body protein turnover (WPT) | WPT will be measured via stable isotope-labeled nitrogen. | Change in WPT will be determined by the difference in WPT between day 1 and day 42. | 
| Resting energy expenditure (REE) | REE will be measured using indirect calorimetry. | Change in REE will be determined by the difference in REE between day 1 and day 42. | 
| Body composition | Body composition will be measured via dual x-ray absorptiometry. | Change in body composition will be determined by the difference in body composition between day 1 and day 42. |