ObeseNCT03386396
Brain Fuel - Morning Nutrition and Cognitive Function
A study testing High protein/low carbohydrate and High carbohydrate/low protein in people with Obese and Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
This study will help us learn more about how what a child eats can affect how their brain works. Read more about this study
- Who is it for?
- Ages 9 to 10 yearsHealthy volunteers can take part
- What is being tested?
- High protein/low carbohydrate and High carbohydrate/low protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2017to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 9 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 9-10 yr, 3rd to 5th grade
- Obese
- Right hand dominance
- Report eating breakfast at least 4 days/week
- Able to hear at least 20dB stimulus
- Visual acuity must be at least 20/40
- Biological mother available to attend visit
Who cannot join
- Full scale IQ <80
- Children taking medications or having chronic illness/disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72203
About this study
Official title: Morning Nutrition and Cognitive Function in Preadolescents
This study will help us learn more about how what a child eats can affect how their brain works.
Read the detailed description
Following a high protein/low carbohydrate meal brain activation and performance measurements will differ from those following a high carbohydrate/low protein meal and executive functioning will be affected.
- Being tested
- High protein/low carbohydrate, High carbohydrate/low protein
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High protein/low carbohydrateDietary supplement
A high protein/low carbohydrate shake will be given to the child.
High carbohydrate/low proteinDietary supplement
A high carbohydrate/low protein shake will be given to the child
| Study group | Role | What they receive |
|---|---|---|
| High protein/low carbohydrate | Experimental | A breakfast shake will be made with high protein/low carbohydrate mixture. Receives: Dietary Supplement: High protein/low carbohydrate |
| High carbohydrate/low protein | Experimental | A breakfast shake will be made with high carbohydrate/low protein mixture. Receives: Dietary Supplement: High carbohydrate/low protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological assessments
Standardized testing
Measured: 9-10 years
Secondary outcomes (1)
Neurocognitive measures
Brain Lab recordings and fMRI readings
Measured: 9-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start28 Nov 2017
- Primary completion6 Jan 2024
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group will be given a high protein/low carbohydrate shake and one group will be given a high carbohydrate/low protein shake
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 151 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda Larson-Prior, PhD, Principal investigator, Arkansas Children's Nutrition Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386396
- Sponsor's protocol ID
- 206464
- Status last verified
- Oct 2025
- First submitted
- 6 Dec 2017
- Last updated
- 20 Oct 2025
- 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 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morning Nutrition and Cognitive Function in Preadolescents
- ClinicalTrials.gov ID
- NCT03386396
- Acronym / sponsor ID
- 206464
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 151 participants (estimated)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 6 Jan 2024 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Dec 2017 (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.
This study will help us learn more about how what a child eats can affect how their brain works.
Detailed description
Following a high protein/low carbohydrate meal brain activation and performance measurements will differ from those following a high carbohydrate/low protein meal and executive functioning will be affected.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- One group will be given a high protein/low carbohydrate shake and one group will be given a high carbohydrate/low protein shake
| Arm | Type | Receives |
|---|---|---|
| High protein/low carbohydrate | Experimental | Dietary Supplement: High protein/low carbohydrateA breakfast shake will be made with high protein/low carbohydrate mixture. |
| High carbohydrate/low protein | Experimental | Dietary Supplement: High carbohydrate/low proteinA breakfast shake will be made with high carbohydrate/low protein mixture. |
Who may qualify
- Ages
- 9 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 9-10 yr, 3rd to 5th grade
- Obese
- Right hand dominance
- Report eating breakfast at least 4 days/week
- Able to hear at least 20dB stimulus
Key exclusion criteria (2 listed)
- Full scale IQ <80
- Children taking medications or having chronic illness/disorders
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 |
|---|---|---|
| High protein/low carbohydrateA high protein/low carbohydrate shake will be given to the child. | Dietary supplement | High protein/low carbohydrate |
| High carbohydrate/low proteinA high carbohydrate/low protein shake will be given to the child | Dietary supplement | High carbohydrate/low protein |
Primary outcome
Psychological assessments
Time frame: 9-10 years
Standardized testing
1 secondary outcome
Neurocognitive measures
Time frame: 9-10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
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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.
Linda Larson-Prior, PhD principal investigator
Arkansas Children's Nutrition Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High protein/low carbohydrate and High carbohydrate/low protein in people with Obese and Healthy, run by Arkansas Children's Hospital Research Institute 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 7 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Psychological assessments (time frame: 9-10 years). 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 20 Oct 2025.