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Effect of Carbohydrates From Nutritional Beverages in Children

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ClinicalTrials.gov Identifier: NCT01355601
Recruitment Status : Terminated (Terminated due to slow recruitment. 41 of 50 participants had enrolled at time of termination.)
First Posted : May 18, 2011
Last Update Posted : February 27, 2014
Sponsor:
Information provided by:

Study Description
Brief Summary:
This clinical trial will determine the effect of varying types of carbohydrates on children's concentration.

Condition or disease Intervention/treatment
Concentration Learning Other: Nutritional Beverage

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Official Title: Effect of Carbohydrates From Nutritional Beverages in Children
Study Start Date : January 2012
Primary Completion Date : February 2014
Study Completion Date : February 2014
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Concentration
    Children's ability to concentrate


Secondary Outcome Measures :
  1. Attention
    Measures of Attention and Distractibility

  2. Short-Term Memory
    Sentence Repetition

  3. Rule Learning
    Rule Learning Tasks


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   33 Months to 39 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children 33 months - 39 months
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01355601


Locations
United States, Kansas
Early Cognition Laboratory
Overland Park, Kansas, United States
Sponsors and Collaborators
Mead Johnson Nutrition
More Information

ClinicalTrials.gov Identifier: NCT01355601     History of Changes
Other Study ID Numbers: 6011
First Posted: May 18, 2011    Key Record Dates
Last Update Posted: February 27, 2014
Last Verified: February 2014