Breakfast and Muscle Health in Children

Not Applicable

Completed

• Conditions: Body Weight Changes; Energy Expenditure; Body Composition; Muscle Mass; Nutrition
• Interventions: Other: Carbohydrate; Other: Protein

• Registration Number: NCT03602144
• Lead Sponsor: University of Arkansas, Fayetteville

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-21
• Study First Submitted: 2018-07-15
• Study First Submitted QC: 2018-07-25
• Study First Posted: 2018-07-26
• Primary Completion: 2019-09-15
• Study Completion: 2020-08-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbohydrate	Carbohydrate	Participants will receive a carbohydrate-based smoothie every morning for 6 weeks (42 days).
Protein	Protein	Participants will receive a protein-based smoothie every morning for 6 weeks (42 days).

Primary Outcome Measures

Name	Time	Method
Whole body energy expenditure (WBEE)	WBEE will be measured as the change between WBEE during day 1 and day 42 of the intervention.	WBEE will be measured using doubly labeled water.

Secondary Outcome Measures

Name	Time	Method
Muscle fractional synthesis rate (FSR)	FSR will be determined as the change between baseline (day 0) and day 42.	FSR will be measured using deuterated water and markers of muscle health in plasma.
Appetite (VAS)	VAS will be measured on day 1 and day 42.	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.
Glycemic Response	Glycemic response will be measured on day 1 and day 42.	Glucose and insulin will be measured using commercially available kits.
Muscle mass	Change in muscle mass will be determined by the difference in muscle mass between day 1 and day 42.	Muscle mass will be measured using stable isotope-labeled creatine.
Whole body protein turnover (WPT)	Change in WPT will be determined by the difference in WPT between day 1 and day 42.	WPT will be measured via stable isotope-labeled nitrogen.
Resting energy expenditure (REE)	Change in REE will be determined by the difference in REE between day 1 and day 42.	REE will be measured using indirect calorimetry.
Body composition	Change in body composition will be determined by the difference in body composition between day 1 and day 42.	Body composition will be measured via dual x-ray absorptiometry.

Trial Locations

Locations (1)

University of Arkansas; 🇺🇸 Fayetteville, Arkansas, United States