Breakfast and Muscle Health in Children

Body Composition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03602144
• Other study ID #: BEMS1
• Status: Completed
• Phase: N/A
• Start date: June 21, 2018
• Est. completion date: August 31, 2020

Study information

• Verified date: February 2021
• Source: University of Arkansas, Fayetteville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: August 31, 2020
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Composition
• Body Weight
• Body Weight Changes
• Energy Expenditure
• Muscle Mass
• Nutrition

Intervention

Other:
• Carbohydrate
Participants will receive a carbohydrate-based breakfast beverage everyone morning for 42 days.
• Protein
Participants will receive a protein-based breakfast beverage everyone morning for 42 days.

Locations

Country	Name	City	State
United States	University of Arkansas	Fayetteville	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas, Fayetteville	University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Glycemic Response	Glucose and insulin will be measured using commercially available kits.	Glycemic response will be measured on day 1 and day 42.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.