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Breakfast and Muscle Health in Children

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03602144
Enrollment
88
Registered
2018-07-26
Start date
2018-06-21
Completion date
2020-08-31
Last updated
2021-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERCarbohydrate

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

OTHERProtein

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

Sponsors

University of Arkansas
CollaboratorOTHER
University of Arkansas, Fayetteville
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 14 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Glycemic ResponseGlycemic response will be measured on day 1 and day 42.Glucose and insulin will be measured using commercially available kits.
Muscle massChange 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.
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.
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 compositionChange 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.
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026