The Effects of Breakfast on Brain Function | NCT00621595

Studies
The Effects of Breakfast on Brain Function

NCT00621595

Sponsor

Arkansas Children's Hospital Research Institute

Status

Completed

Last Update Posted

Sep 11, 2015Estimated

Enrollment

166Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

USDA School Breakfast

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2000

Primary Completion Date

Jun 2005Actual

Completion Date

Jun 2005Actual

First Submitted Date

Feb 12, 2008

First Submission Date that Met QC Criteria

Feb 21, 2008

First Posted Date

Feb 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2015

Last Update Posted Date

Sep 11, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To test cognitive abilities of 8-11 year old children under conditions of fasting or receiving a full school breakfast.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

166Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Fasting	Dietary Supplement: USDA School Breakfast

Interventions

Name	Type	Description	Arm Group Labels	Other Names
USDA School Breakfast	Dietary Supplement	Breakfast containing 340 calories, 57 g carbohydrate, 14 g protein, 6 g fat.	1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

8-11 years old
Between 25th and 95th percentile, BMI-for-age

Exclusion Criteria:

food allergies or some intolerances
uncorrected vision
IQ < 80
Other chronic conditions thought to interfere with the study as determined by the investigator

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
R Terry Pivik, Ph.D.	University of Arkansas for Medial Science	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Children's Nutrition Center		Little Rock	Arkansas	72202	United States