Effects of Breakfast on Cognitive Processes in Children
A Randomized, Controlled, Parallel Trial to Evaluate the Effects of Breakfast on Cognitive Processes in Children
1 other identifier
interventional
291
1 country
1
Brief Summary
The objective of this study is to test the effects of breakfast on cognitive processing ability in children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2009
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 4, 2010
CompletedFirst Posted
Study publicly available on registry
February 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedFebruary 20, 2020
August 1, 2015
4 months
February 4, 2010
February 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Quality of Memory and Attention based on results using CDR System
4 hours following breakfast
Secondary Outcomes (1)
Speed of Memory and Attention based on results using CDR System
4 hours following breakfast
Study Arms (2)
breakfast cereal
EXPERIMENTALbreakfast cereal and milk
water
PLACEBO COMPARATORwater
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kellogg Companylead
- Provident Clinical Researchcollaborator
Study Sites (1)
Provident Clinical Research
Addison, Illinois, 60101, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kevin Maki, Ph.D.
Provident Clinical Research
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2010
First Posted
February 5, 2010
Study Start
December 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
February 20, 2020
Record last verified: 2015-08