NCT00621595

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Nov 2000

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 22, 2008

Completed
Last Updated

September 11, 2015

Status Verified

September 1, 2015

Enrollment Period

4.6 years

First QC Date

February 12, 2008

Last Update Submit

September 9, 2015

Conditions

Healthy

Keywords

School BreakfastDietNutritionBrain FunctionCognitionUSDAHealthy Children

Study Arms (1)

1

ACTIVE COMPARATOR

Fasting

Dietary Supplement: USDA School Breakfast

Interventions

USDA School BreakfastDIETARY_SUPPLEMENT

Breakfast containing 340 calories, 57 g carbohydrate, 14 g protein, 6 g fat.

1

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Location

Study Officials

  • R Terry Pivik, Ph.D.

    University of Arkansas for Medial Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 12, 2008

First Posted

February 22, 2008

Study Start

November 1, 2000

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

September 11, 2015

Record last verified: 2015-09

Locations

US(1)