HealthyNCT00621595
The Effects of Breakfast on Brain Function
A study testing USDA School Breakfast in people with Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
To test cognitive abilities of 8-11 year old children under conditions of fasting or receiving a full school breakfast. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- USDA School Breakfast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2000to Jun 2005
- 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 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 8-11 years old
- Between 25th and 95th percentile, BMI-for-age
Who cannot join
- food allergies or some intolerances
- uncorrected vision
- IQ < 80
- Other chronic conditions thought to interfere with the study as determined by the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
About this study
Official title: The Effects of Breakfast on Cognitive Functioning
To test cognitive abilities of 8-11 year old children under conditions of fasting or receiving a full school breakfast.
- Conditions
- Healthy
- Being tested
- USDA School Breakfast
- Keywords
- School Breakfast, Diet, Nutrition, Brain Function, Cognition, USDA, Healthy Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USDA School BreakfastDietary supplement
Breakfast containing 340 calories, 57 g carbohydrate, 14 g protein, 6 g fat.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Fasting Receives: Dietary Supplement: USDA School Breakfast |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startNov 2000
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- R Terry Pivik, Ph.D., Principal investigator, University of Arkansas for Medial Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621595
- Sponsor's protocol ID
- 06278
- Status last verified
- Sep 2015
- First submitted
- 12 Feb 2008
- Last updated
- 11 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Breakfast on Cognitive Functioning
- ClinicalTrials.gov ID
- NCT00621595
- Acronym / sponsor ID
- 06278
- Conditions
- Healthy
- Keywords
- School Breakfast, Diet, Nutrition, Brain Function, Cognition, USDA, Healthy Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- Nov 2000
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 22 Feb 2008 (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.
To test cognitive abilities of 8-11 year old children under conditions of fasting or receiving a full school breakfast.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: USDA School BreakfastFasting |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 8-11 years old
- Between 25th and 95th percentile, BMI-for-age
Key exclusion criteria (4 listed)
- food allergies or some intolerances
- uncorrected vision
- IQ < 80
- Other chronic conditions thought to interfere with the study as determined by the investigator
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 |
|---|---|---|
| USDA School BreakfastBreakfast containing 340 calories, 57 g carbohydrate, 14 g protein, 6 g fat. | Dietary supplement | 1 |
Primary outcome
Not reported in the source record.
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 11 Sep 2015.
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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.
R Terry Pivik, Ph.D. principal investigator
University of Arkansas for Medial Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing USDA School Breakfast in people with 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 2 inclusion and 4 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 11 Sep 2015. 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.
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 11 Sep 2015.