Breakfast and Muscle Health in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-21

Study Completion Date

2020-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Body Weight Changes Body Composition Muscle Mass Energy Expenditure Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Carbohydrate

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

Group Type ACTIVE_COMPARATOR

Carbohydrate

Intervention Type OTHER

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

Protein

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

Group Type EXPERIMENTAL

Protein

Intervention Type OTHER

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

Interventions

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Carbohydrate

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

Intervention Type OTHER

Protein

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes