Cognitive FunctionNCT01063894
Effects of Breakfast on Cognitive Processes in Children
A study testing breakfast cereal and water in people with Cognitive Function, run by Kellogg Company at 1 site in United States.
Trial summary
The objective of this study is to test the effects of breakfast on cognitive processing ability in children. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function
- What is being tested?
- breakfast cereal and water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 291 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Apr 2010
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subject is willing to maintain their habitual diet and physical activity patterns throughout the study period
- Provision of assent by subject
- Subject's guardian provides informed consent to participate in the study and authorization for release of relevant protected health information to the study investigators
Who cannot join
- Diagnosis of attention deficit disorder, with or without hyperactivity
- A diagnosis of diabetes mellitus
- Acute illness or use of antibiotics within 5 days of visit
- Subject is a non-breakfast eater defined as not regularly eating food prior to 1000 h
- Known sensitivity or allergy to any ingredients of the study product
- Use of any psychotropic medication within 4 weeks
Show all 9Show fewer
- Subject did not previously participate in an earlier trial with the same study products
- Exposure to investigational agent within 30 days.
- Individual has a condition the Investigator believes would interfere with his or her ability to provide assent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk
Trial locations and contacts
1 site in 1 country.
United States1 site
Provident Clinical Research
Addison, Illinois, 60101
About this study
Official title: A Randomized, Controlled, Parallel Trial to Evaluate the Effects of Breakfast on Cognitive Processes in Children
The objective of this study is to test the effects of breakfast on cognitive processing ability in children.
Read the detailed description
Breakfast consumption has previously been shown to positively affect cognitive and academic performance in children. Specifically, breakfast consumption has been reported to improve memory, attention, problem solving, and logical reasoning compared to the absence of breakfast. This has been found under both short-term laboratory conditions and within a school environment in children from both a low and high socioeconomic background, although some studies have failed to find favorable effects.
- Conditions
- Cognitive Function
- Being tested
- breakfast cereal, water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breakfast cerealOther
breakfast cereal and milk
waterOther
water
| Study group | Role | What they receive |
|---|---|---|
| breakfast cereal | Experimental | breakfast cereal and milk Receives: Other: breakfast cereal |
| water | Placebo comparator | water Receives: Other: water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Memory and Attention based on results using CDR System
Measured: 4 hours following breakfast
Secondary outcomes (1)
Speed of Memory and Attention based on results using CDR System
Measured: 4 hours following breakfast
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startDec 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kellogg Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Provident Clinical Research
- Responsible party
- Sponsor
- Investigators
- Kevin Maki, Ph.D., Study director, Provident Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063894
- Sponsor's protocol ID
- PRV-09013
- Status last verified
- Aug 2015
- First submitted
- 4 Feb 2010
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Parallel Trial to Evaluate the Effects of Breakfast on Cognitive Processes in Children
- ClinicalTrials.gov ID
- NCT01063894
- Acronym / sponsor ID
- PRV-09013
- Conditions
- Cognitive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Kellogg CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Provident Clinical Research
- Study start
- Dec 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 5 Feb 2010 (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.
The objective of this study is to test the effects of breakfast on cognitive processing ability in children.
Detailed description
Breakfast consumption has previously been shown to positively affect cognitive and academic performance in children. Specifically, breakfast consumption has been reported to improve memory, attention, problem solving, and logical reasoning compared to the absence of breakfast. This has been found under both short-term laboratory conditions and within a school environment in children from both a low and high socioeconomic background, although some studies have failed to find favorable effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| breakfast cereal | Experimental | Other: breakfast cerealbreakfast cereal and milk |
| water | Placebo comparator | Other: waterwater |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subject is willing to maintain their habitual diet and physical activity patterns throughout the study period
- Provision of assent by subject
- Subject's guardian provides informed consent to participate in the study and authorization for release of relevant protected health information to the study investigators
Key exclusion criteria (9 listed)
- Diagnosis of attention deficit disorder, with or without hyperactivity
- A diagnosis of diabetes mellitus
- Acute illness or use of antibiotics within 5 days of visit
- Subject is a non-breakfast eater defined as not regularly eating food prior to 1000 h
- Known sensitivity or allergy to any ingredients of the study product
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 |
|---|---|---|
| breakfast cerealbreakfast cereal and milk | Other | breakfast cereal |
| waterwater | Other | water |
Primary outcome
Quality of Memory and Attention based on results using CDR System
Time frame: 4 hours following breakfast
1 secondary outcome
Speed of Memory and Attention based on results using CDR System
Time frame: 4 hours following breakfast
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 20 Feb 2020.
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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.
Kevin Maki, Ph.D. study director
Provident Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breakfast cereal and water in people with Cognitive Function, run by Kellogg Company 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 3 inclusion and 9 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 20 Feb 2020. 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. Some participants in this study may receive a placebo. 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?
Quality of Memory and Attention based on results using CDR System (time frame: 4 hours following breakfast). 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 Feb 2020.