Effects of a Breakfast and Snack on Cognitive Function in... | NCT01592487

Studies
Effects of a Breakfast and Snack on Cognitive Function in Preadolescents

NCT01592487

Sponsor

University of Arkansas

Status

Withdrawn

Last Update Posted

Feb 12, 2014Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Brain Function

Interventions

Not provided

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

Feb 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study never started, and there are no plans to initiate.

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

May 3, 2012

First Submission Date that Met QC Criteria

May 3, 2012

First Posted Date

May 7, 2012Estimated

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

Feb 11, 2014

Last Update Posted Date

Feb 12, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This study is designed to test how breakfast affects brain function, memory and learning in healthy children.

Hypotheses: Based on the results of our initial study and the relevant literature, it is hypothesized that arousal, attention, and performance will be:

Greater in those who eat breakfast relative to those who do not;
Greater in lean than in overweight children receiving the higher protein breakfast;
Greater in fasting lean than fasting overweight children; and
Improved following a morning snack in all study groups.
Poorer in children with higher stress-related measures (e.g., higher cortisol levels).
Heart rate will be lower in fasting relative to fed participants, and across groups will be higher in overweight children.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lean BMI		BMI in the 25th - 75th percentile
Overweight BMI		BMI in the 85th - 95th percentile

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy
attending 4th or 5th grade
lean BMI or overweight BMI
right hand dominance
no food allergies
eat breakfast at least 4 mornings/week
no medications for chronic illness/disorder that may affect outcome (as determined by the PI)

Exclusion Criteria:

food allergies
medications that could affect the outcome
left hand dominance

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

healthy 4th and 5th graders

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

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