Breakfast and Muscle Health in Children
Primary Purpose
Body Weight Changes, Body Composition, Muscle Mass
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Carbohydrate
Protein
Sponsored by
About this trial
This is an interventional basic science trial for Body Weight Changes
Eligibility Criteria
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
Sites / Locations
- University of Arkansas
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Carbohydrate
Protein
Arm Description
Participants will receive a carbohydrate-based smoothie every morning for 6 weeks (42 days).
Participants will receive a protein-based smoothie every morning for 6 weeks (42 days).
Outcomes
Primary Outcome Measures
Whole body energy expenditure (WBEE)
WBEE will be measured using doubly labeled water.
Secondary Outcome Measures
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.
Glycemic Response
Glucose and insulin will be measured using commercially available kits.
Muscle mass
Muscle mass will be measured using stable isotope-labeled creatine.
Muscle fractional synthesis rate (FSR)
FSR will be measured using deuterated water and markers of muscle health in plasma.
Whole body protein turnover (WPT)
WPT will be measured via stable isotope-labeled nitrogen.
Resting energy expenditure (REE)
REE will be measured using indirect calorimetry.
Body composition
Body composition will be measured via dual x-ray absorptiometry.
Full Information
NCT ID
NCT03602144
First Posted
July 15, 2018
Last Updated
February 3, 2021
Sponsor
University of Arkansas, Fayetteville
Collaborators
University of Arkansas
1. Study Identification
Unique Protocol Identification Number
NCT03602144
Brief Title
Breakfast and Muscle Health in Children
Official Title
Breakfast, Energy Metabolism, and Skeletal Muscle Health in Obese Children
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 21, 2018 (Actual)
Primary Completion Date
September 15, 2019 (Actual)
Study Completion Date
August 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arkansas, Fayetteville
Collaborators
University of Arkansas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight Changes, Body Composition, Muscle Mass, Energy Expenditure, Nutrition
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Carbohydrate
Arm Type
Active Comparator
Arm Description
Participants will receive a carbohydrate-based smoothie every morning for 6 weeks (42 days).
Arm Title
Protein
Arm Type
Experimental
Arm Description
Participants will receive a protein-based smoothie every morning for 6 weeks (42 days).
Intervention Type
Other
Intervention Name(s)
Carbohydrate
Intervention Description
Participants will receive a carbohydrate-based breakfast beverage everyone morning for 42 days.
Intervention Type
Other
Intervention Name(s)
Protein
Intervention Description
Participants will receive a protein-based breakfast beverage everyone morning for 42 days.
Primary Outcome Measure Information:
Title
Whole body energy expenditure (WBEE)
Description
WBEE will be measured using doubly labeled water.
Time Frame
WBEE will be measured as the change between WBEE during day 1 and day 42 of the intervention.
Secondary Outcome Measure Information:
Title
Appetite (VAS)
Description
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.
Time Frame
VAS will be measured on day 1 and day 42.
Title
Glycemic Response
Description
Glucose and insulin will be measured using commercially available kits.
Time Frame
Glycemic response will be measured on day 1 and day 42.
Title
Muscle mass
Description
Muscle mass will be measured using stable isotope-labeled creatine.
Time Frame
Change in muscle mass will be determined by the difference in muscle mass between day 1 and day 42.
Title
Muscle fractional synthesis rate (FSR)
Description
FSR will be measured using deuterated water and markers of muscle health in plasma.
Time Frame
FSR will be determined as the change between baseline (day 0) and day 42.
Title
Whole body protein turnover (WPT)
Description
WPT will be measured via stable isotope-labeled nitrogen.
Time Frame
Change in WPT will be determined by the difference in WPT between day 1 and day 42.
Title
Resting energy expenditure (REE)
Description
REE will be measured using indirect calorimetry.
Time Frame
Change in REE will be determined by the difference in REE between day 1 and day 42.
Title
Body composition
Description
Body composition will be measured via dual x-ray absorptiometry.
Time Frame
Change in body composition will be determined by the difference in body composition between day 1 and day 42.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie I Baum, PhD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72704
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Breakfast and Muscle Health in Children
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