Breakfast and Muscle Health in Children

NCT03602144 | Completed

• 1 other identifier: BEMS1
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Appetite (VAS)

  VAS will be measured on day 1 and day 42.

• Glycemic Response

  Glycemic response will be measured on day 1 and day 42.

• Muscle mass

  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 determined as the change between baseline (day 0) and day 42.

• Whole body protein turnover (WPT)

  Change in WPT will be determined by the difference in WPT between day 1 and day 42.

Study Arms (2)

Carbohydrate

ACTIVE COMPARATOR

Participants will receive a carbohydrate-based smoothie every morning for 6 weeks (42 days).

Other: Carbohydrate

Protein

EXPERIMENTAL

Participants will receive a protein-based smoothie every morning for 6 weeks (42 days).

Other: Protein

Interventions

Carbohydrate OTHER

Participants will receive a carbohydrate-based breakfast beverage everyone morning for 42 days.

Carbohydrate

Protein OTHER

Participants will receive a protein-based breakfast beverage everyone morning for 42 days.

Protein

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas, Fayetteville: lead
• University of Arkansas: collaborator

Study Sites (1)

University of Arkansas

Fayetteville, Arkansas, 72704, United States

Location

MeSH Terms

Conditions

Body Weight Changes

Interventions

Carbohydrates; Proteins

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Jamie I Baum, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 15, 2018
• First Posted: July 26, 2018
• Study Start: June 21, 2018
• Primary Completion: September 15, 2019
• Study Completion: August 31, 2020
• Last Updated: February 4, 2021

Record last verified: 2021-02

Locations

US (1)