- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01355601
Effect of Carbohydrates From Nutritional Beverages in Children
February 26, 2014 updated by: Mead Johnson Nutrition
This clinical trial will determine the effect of varying types of carbohydrates on children's concentration.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
88
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kansas
-
Overland Park, Kansas, United States
- Early Cognition Laboratory
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 3 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children 33 months - 39 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1 - Control A
Nutritional beverage containing varying types and levels of carbohydrates
|
Nutritional Beverage with varying types and levels of carbohydrates
Nutritional beverage with varying types and levels of carbohydrates
|
Experimental: Group 2 - Experimental A
Nutritional Beverage with varying types and levels of carbohydrates
|
Nutritional Beverage with varying types and levels of carbohydrates
Nutritional beverage with varying types and levels of carbohydrates
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
Concentration
|
Children's ability to concentrate
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
Attention
|
Measures of Attention and Distractibility
|
Short-Term Memory
|
Sentence Repetition
|
Rule Learning
|
Rule Learning Tasks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
May 16, 2011
First Submitted That Met QC Criteria
May 17, 2011
First Posted (Estimate)
May 18, 2011
Study Record Updates
Last Update Posted (Estimate)
February 27, 2014
Last Update Submitted That Met QC Criteria
February 26, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 6011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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