NCT01355601

Brief Summary

This clinical trial will determine the effect of varying types of carbohydrates on children's concentration.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

May 16, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 27, 2014

Status Verified

February 1, 2014

Enrollment Period

2.1 years

First QC Date

May 16, 2011

Last Update Submit

February 26, 2014

Conditions

ConcentrationLearning

Outcome Measures

Primary Outcomes (1)

  • Concentration

    Children's ability to concentrate

Secondary Outcomes (3)

  • Attention

  • Short-Term Memory

  • Rule Learning

Study Arms (2)

Group 1 - Control A

EXPERIMENTAL

Nutritional beverage containing varying types and levels of carbohydrates

Other: Nutritional Beverage

Group 2 - Experimental A

EXPERIMENTAL

Nutritional Beverage with varying types and levels of carbohydrates

Other: Nutritional Beverage

Interventions

Nutritional BeverageOTHER

Nutritional Beverage with varying types and levels of carbohydrates

Group 1 - Control A

Eligibility Criteria

Age33 Months - 39 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children 33 months - 39 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Early Cognition Laboratory

Overland Park, Kansas, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 16, 2011

First Posted

May 18, 2011

Study Start

January 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 27, 2014

Record last verified: 2014-02

Locations

US(1)