Brain FunctionNCT01592487
Effects of a Breakfast and Snack on Cognitive Function in Preadolescents
An observational study of Brain Function, run by University of Arkansas at 1 site in United States.
Trial summary
This study is designed to test how breakfast affects brain function, memory and learning in healthy children. Hypotheses: Based on the results of our initial study and the relevant literature, it is hypothesized that arousal, attention, and performance will be: 1. Read more about this study
- Who is it for?
- Ages 9 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Function
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Dec 2013
- Phase
- Observational
- 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 9 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: healthy 4th and 5th graders
Who may be able to join
- healthy
- attending 4th or 5th grade
- lean BMI or overweight BMI
- right hand dominance
- no food allergies
- eat breakfast at least 4 mornings/week
- no medications for chronic illness/disorder that may affect outcome (as determined by the PI)
Who cannot join
- food allergies
- medications that could affect the outcome
- left hand dominance
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
About this study
This study is designed to test how breakfast affects brain function, memory and learning in healthy children.
Hypotheses: Based on the results of our initial study and the relevant literature, it is hypothesized that arousal, attention, and performance will be:
- Greater in those who eat breakfast relative to those who do not;
- Greater in lean than in overweight children receiving the higher protein breakfast;
- Greater in fasting lean than fasting overweight children; and
- Improved following a morning snack in all study groups.
- Poorer in children with higher stress-related measures (e.g., higher cortisol levels).
- Heart rate will be lower in fasting relative to fed participants, and across groups will be higher in overweight children.
- Conditions
- Brain Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lean BMI | BMI in the 25th - 75th percentile | |
| Overweight BMI | BMI in the 85th - 95th percentile |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startDec 2013
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Study never started, and there are no plans to initiate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain FunctionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592487
- Sponsor's protocol ID
- 114663
- Status last verified
- Feb 2014
- First submitted
- 3 May 2012
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Breakfast and Snack on Cognitive Function in Preadolescents
- ClinicalTrials.gov ID
- NCT01592487
- Acronym / sponsor ID
- 114663
- Conditions
- Brain Function
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study never started, and there are no plans to initiate.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 May 2012 (estimated)
- 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 is designed to test how breakfast affects brain function, memory and learning in healthy children.
Hypotheses: Based on the results of our initial study and the relevant literature, it is hypothesized that arousal, attention, and performance will be:
- Greater in those who eat breakfast relative to those who do not;
- Greater in lean than in overweight children receiving the higher protein breakfast;
- Greater in fasting lean than fasting overweight children; and
- Improved following a morning snack in all study groups.
- Poorer in children with higher stress-related measures (e.g., higher cortisol levels).
- Heart rate will be lower in fasting relative to fed participants, and across groups will be higher in overweight children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lean BMI | – | –BMI in the 25th - 75th percentile |
| Overweight BMI | – | –BMI in the 85th - 95th percentile |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- healthy 4th and 5th graders
Key inclusion criteria (7 listed)
- healthy
- attending 4th or 5th grade
- lean BMI or overweight BMI
- right hand dominance
- no food allergies
Key exclusion criteria (3 listed)
- food allergies
- medications that could affect the outcome
- left hand dominance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Function, run by University of Arkansas 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 3 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: withdrawn, as of the sponsor's last update on 12 Feb 2014. 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 was withdrawn before enrolling participants, so there are no results.
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.
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 12 Feb 2014.