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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014