Dietary Modification Clinical Trial
Official title:
The Acute Effects of Fortified Nutritional Supplementation on Cognition, Memory, & Achievement
NCT number | NCT02630667 |
Other study ID # | 12641 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | August 25, 2015 |
Last updated | December 7, 2016 |
Start date | June 2012 |
The aim of this study is to investigate the acute effects of ingestion of carbohydrates - with different glycemic profiles - on cognitive function among preadolescent children (i.e., 9-10 years).
Status | Completed |
Enrollment | 113 |
Est. completion date | |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 9 Years to 10 Years |
Eligibility |
Inclusion Criteria: - Parental/guardian consent. - Participants must be between the ages of 9-10 years old at the time of testing age - Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision). - Participants must have an IQ > 85 (IQ < 85). Exclusion Criteria: - Prior diagnosis of cognitive or physical disability, including ADHD (severe asthma, epilepsy, and dependence upon a wheelchair/walking aid, and ADHD Rating Scale score below 85%). - Use of anti-psychotic, anti-depressant, anti-anxiety medication, as well as those medications used for ADD/ADHD (use of any anti-psychotic, anti-depressant, anti-anxiety, and ADD/ADHD medications). - Early pubertal status, as measured by a modified test of the Tanner Staging System (onset of puberty as determined by Tanner). - Lactose intolerance - Allergies to milk and/or soy - Adherence to a strict vegan diet |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
United States | Department of Kinesiology and Community Health | Urbana | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Urbana-Champaign | Abbott Nutrition |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Cognitive Control at 15 minutes Postprandial | Performance will be assessed using the difference in inverse efficiency (during a modified flanker task) between performance at 15 minutes and baseline/fasted (within 2 hours of wake-time) performance. | 15 minutes Postprandial | No |
Primary | Change in Cognitive Control at 70 minutes Postprandial | Performance will be assessed using the difference in inverse efficiency (during a modified flanker task) between performance at 70 minutes and baseline/fasted (within 2 hours of wake-time). | 70 minutes Postprandial | No |
Secondary | Change in Relational Memory at 30 minutes Postprandial | Performance will be assessed using the difference in number of swap errors (during a spatial reconstruction task) by calculating the difference between number of errors performed at baseline/fasted (within 2 hours of wake-time) from number of errors at 30 minutes postprandial. | 30 minutes Postprandial | No |
Secondary | Change in Relational Memory at 85 minutes Postprandial | Performance will be assessed using the difference in number of swap errors (during a spatial reconstruction task) by calculating the difference between number of errors performed at baseline/fasted (within 2 hours of wake-time) from number of errors at 85 minutes postprandial. | 85 minutes Postprandial | No |
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