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Breakfast and Muscle Health in Children

Sponsor
University of Arkansas, Fayetteville (Other)
Overall Status
Completed
CT.gov ID
NCT03602144
Collaborator
University of Arkansas (Other)
88
Enrollment
1
Location
2
Arms
26.3
Actual Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Carbohydrate
  • Other: Protein
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Breakfast, Energy Metabolism, and Skeletal Muscle Health in Obese Children
Actual Study Start Date :
Jun 21, 2018
Actual Primary Completion Date :
Sep 15, 2019
Actual Study Completion Date :
Aug 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Carbohydrate

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

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

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

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. Glycemic Response [Glycemic response will be measured on day 1 and day 42.]

    Glucose and insulin will be measured using commercially available kits.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 14 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Arkansas Fayetteville Arkansas United States 72704

Sponsors and Collaborators

  • University of Arkansas, Fayetteville
  • University of Arkansas

Investigators

  • Principal Investigator: Jamie I Baum, PhD, University of Arkansas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jamie Baum, Assistant Professor, University of Arkansas, Fayetteville
ClinicalTrials.gov Identifier:
NCT03602144
Other Study ID Numbers:
  • BEMS1
First Posted:
Jul 26, 2018
Last Update Posted:
Feb 4, 2021
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Body Weight
Body Weight Changes

Study Results

No Results Posted as of Feb 4, 2021