Body Weight ChangesNCT03602144
Breakfast and Muscle Health in Children
A study testing Carbohydrate and Protein in people with Body Weight Changes and Body Composition, run by University of Arkansas, Fayetteville at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight Changes, Body Composition, Muscle Mass
- What is being tested?
- Carbohydrate and Protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2018to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Resides within Northwest Arkansas
- Age 8-12 years old
- BMI >5th percentile
- All ethnicities
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas
Fayetteville, Arkansas, 72704
About this study
Official title: Breakfast, Energy Metabolism, and Skeletal Muscle Health in Obese 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.
- Being tested
- Carbohydrate, Protein
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbohydrateOther
Participants will receive a carbohydrate-based breakfast beverage everyone morning for 42 days.
ProteinOther
Participants will receive a protein-based breakfast beverage everyone morning for 42 days.
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate | Active comparator | Participants will receive a carbohydrate-based smoothie every morning for 6 weeks (42 days). Receives: Other: Carbohydrate |
| Protein | Experimental | Participants will receive a protein-based smoothie every morning for 6 weeks (42 days). Receives: Other: Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole body energy expenditure (WBEE)
WBEE will be measured using doubly labeled water.
Measured: WBEE will be measured as the change between WBEE during day 1 and day 42 of the intervention.
Secondary outcomes (7)
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.
Measured: VAS will be measured on day 1 and day 42.
Glycemic Response
Glucose and insulin will be measured using commercially available kits.
Measured: Glycemic response will be measured on day 1 and day 42.
Muscle mass
Muscle mass will be measured using stable isotope-labeled creatine.
Measured: Change in muscle mass will be determined by the difference in muscle mass between day 1 and day 42.
Muscle fractional synthesis rate (FSR)
FSR will be measured using deuterated water and markers of muscle health in plasma.
Measured: FSR will be determined as the change between baseline (day 0) and day 42.
Whole body protein turnover (WPT)
WPT will be measured via stable isotope-labeled nitrogen.
Measured: Change in WPT will be determined by the difference in WPT between day 1 and day 42.
Resting energy expenditure (REE)
REE will be measured using indirect calorimetry.
Measured: Change in REE will be determined by the difference in REE between day 1 and day 42.
Body composition
Body composition will be measured via dual x-ray absorptiometry.
Measured: Change in body composition will be determined by the difference in body composition between day 1 and day 42.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start21 Jun 2018
- Primary completion15 Sep 2019
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Weight ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas, Fayetteville
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arkansas
- Responsible party
- Principal investigator, Jamie Baum, University of Arkansas, Fayetteville
- Investigators
- Jamie I Baum, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602144
- Sponsor's protocol ID
- BEMS1
- Status last verified
- Feb 2021
- First submitted
- 15 Jul 2018
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breakfast, Energy Metabolism, and Skeletal Muscle Health in Obese Children
- ClinicalTrials.gov ID
- NCT03602144
- Acronym / sponsor ID
- BEMS1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of Arkansas, FayettevilleUniversity, hospital or other
- Collaborators
- University of Arkansas
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate | Active comparator | Other: CarbohydrateParticipants will receive a carbohydrate-based smoothie every morning for 6 weeks (42 days). |
| Protein | Experimental | Other: ProteinParticipants will receive a protein-based smoothie every morning for 6 weeks (42 days). |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Resides within Northwest Arkansas
- Age 8-12 years old
- BMI >5th percentile
- All ethnicities
Key exclusion criteria (7 listed)
- Food allergies
- Dietary restrictions
- Regularly skip breakfast (> 5 times per week)
- Prescription medications
- Claustrophobic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarbohydrateParticipants will receive a carbohydrate-based breakfast beverage everyone morning for 42 days. | Other | Carbohydrate |
| ProteinParticipants will receive a protein-based breakfast beverage everyone morning for 42 days. | Other | Protein |
Primary outcome
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.
7 secondary outcomes
Appetite (VAS)
Time frame: VAS will be measured on day 1 and day 42.
Glycemic Response
Time frame: Glycemic response will be measured on day 1 and day 42.
Muscle mass
Time frame: Change in muscle mass will be determined by the difference in muscle mass between day 1 and day 42.
Muscle fractional synthesis rate (FSR)
Time frame: FSR will be determined as the change between baseline (day 0) and day 42.
Whole body protein turnover (WPT)
Time frame: Change in WPT will be determined by the difference in WPT between day 1 and day 42.
Resting energy expenditure (REE)
Time frame: Change in REE will be determined by the difference in REE between day 1 and day 42.
Body composition
Time frame: Change in body composition will be determined by the difference in body composition between day 1 and day 42.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie I Baum, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate and Protein in people with Body Weight Changes and Body Composition, run by University of Arkansas, Fayetteville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.