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OpenTrials
Completed

NCT Number: NCT01063894

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.

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Key information

Conditions

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Provident Clinical Research

Addison, Illinois, 60101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

breakfast cereal

Other

breakfast cereal and milk

Water

Other

water

Primary outcomes

  1. Quality of Memory and Attention based on results using CDR System

    Time frame: 4 hours following breakfast

Secondary outcomes

  1. Speed of Memory and Attention based on results using CDR System

    Time frame: 4 hours following breakfast

Sponsors and collaborators

Lead sponsor

Kellogg Company

Industry

Collaborators

  • Provident Clinical Research

Registry information

Official study title

A Randomized, Controlled, Parallel Trial to Evaluate the Effects of Breakfast on Cognitive Processes in Children

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 5, 2010
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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