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Effect of Carbohydrates From Nutritional Beverages in Children

This study is currently recruiting participants.
Verified April 2013 by Mead Johnson Nutrition
Sponsor:
Information provided by:
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT01355601
First received: May 16, 2011
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  Purpose

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


Condition Intervention
Concentration
Learning
 Other: Nutritional Beverage

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Official Title: Effect of Carbohydrates From Nutritional Beverages in Children

Further study details as provided by Mead Johnson Nutrition:

Primary Outcome Measures:
  • Concentration [ Designated as safety issue: No ]
    Children's ability to concentrate


Secondary Outcome Measures:
  • Attention [ Designated as safety issue: No ]
    Measures of Attention and Distractibility

  • Short-Term Memory [ Designated as safety issue: No ]
    Sentence Repetition

  • Rule Learning [ Designated as safety issue: No ]
    Rule Learning Tasks


Estimated Enrollment: 88
Study Start Date: January 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 - Control A
Nutritional beverage containing varying types and levels of carbohydrates
 Other: Nutritional Beverage
Nutritional Beverage with varying types and levels of carbohydrates
Experimental: Group 2 - Experimental A
Nutritional Beverage with varying types and levels of carbohydrates
 Other: Nutritional Beverage
Nutritional beverage with varying types and levels of carbohydrates

  Eligibility

Ages Eligible for Study:   33 Months to 39 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children 33 months - 39 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01355601

Contacts
Contact: John Colombo, Ph.D. 785-864-4131 colombo@ku.edu

Locations
United States, Kansas
Early Cognition Laboratory Recruiting
Overland Park, Kansas, United States
Contact: John Colombo, Ph.D.     913-864-8590     colombo@ku.edu    
Sponsors and Collaborators
Mead Johnson Nutrition
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01355601     History of Changes
Other Study ID Numbers: 6011
Study First Received: May 16, 2011
Last Updated: April 23, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 22, 2013