The Effects of Breakfast on Brain Function
This study has been completed.
Sponsor:
Arkansas Children's Hospital Research Institute
Collaborators:
USDA Beltsville Human Nutrition Research Center
University of Arkansas
Information provided by:
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00621595
First received: February 12, 2008
Last updated: August 19, 2009
Last verified: August 2009
| Tracking Information | |||||
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| First Received Date ICMJE | February 12, 2008 | ||||
| Last Updated Date | August 19, 2009 | ||||
| Start Date ICMJE | November 2000 | ||||
| Primary Completion Date | June 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00621595 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effects of Breakfast on Brain Function | ||||
| Official Title ICMJE | The Effects of Breakfast on Cognitive Functioning | ||||
| Brief Summary | To test cognitive abilities of 8-11 year old children under conditions of fasting or receiving a full school breakfast. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Dietary Supplement: USDA School Breakfast
Breakfast containing 340 calories, 57 g carbohydrate, 14 g protein, 6 g fat. |
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| Study Arm (s) | Active Comparator: 1
Fasting
Intervention: Dietary Supplement: USDA School Breakfast |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 166 | ||||
| Completion Date | June 2005 | ||||
| Primary Completion Date | June 2005 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 8 Years to 11 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00621595 | ||||
| Other Study ID Numbers ICMJE | 06278 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | R. Terry Pivik, Ph.D. / Principal Investigator, University of Arkansas for Medical Science | ||||
| Study Sponsor ICMJE | Arkansas Children's Hospital Research Institute | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Arkansas Children's Hospital Research Institute | ||||
| Verification Date | August 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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