Effect of Carbohydrates From Nutritional Beverages in Children

This study has been terminated.
(Terminated due to slow recruitment. 41 of 50 participants had enrolled at time of termination.)
Sponsor:
Information provided by:
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT01355601
First received: May 16, 2011
Last updated: February 26, 2014
Last verified: February 2014
  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
Study Completion Date: February 2014
Primary Completion Date: February 2014 (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

Locations
United States, Kansas
Early Cognition Laboratory
Overland Park, Kansas, United States
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: February 26, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 22, 2014