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Completed

NCT Number: NCT03602144

Breakfast and Muscle Health in Children

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.

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Key information

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas

Fayetteville, Arkansas, 72704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carbohydrate

Other

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

Protein

Other

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

Primary outcomes

  1. Whole body energy expenditure (WBEE)

    Time frame: 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 outcomes

  1. Appetite (VAS)

    Time frame: 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.

  2. Glycemic Response

    Time frame: Glycemic response will be measured on day 1 and day 42.

    Glucose and insulin will be measured using commercially available kits.

  3. Muscle mass

    Time frame: 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.

  4. Muscle fractional synthesis rate (FSR)

    Time frame: 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.

  5. Whole body protein turnover (WPT)

    Time frame: 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.

  6. Resting energy expenditure (REE)

    Time frame: Change in REE will be determined by the difference in REE between day 1 and day 42.

    REE will be measured using indirect calorimetry.

  7. Body composition

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Arkansas, Fayetteville

Other

Collaborators

  • University of Arkansas

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 26, 2018
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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