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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03586622 -
One Year Home Monitoring and Treatment of IBS Patients
|
N/A | |
Withdrawn |
NCT02863822 -
Study to Evaluate Dietary Modification in Patients With Functional Dyspepsia.
|
N/A | |
Not yet recruiting |
NCT02858557 -
The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases
|
N/A | |
Completed |
NCT03048487 -
Protein Consumption in Critically Ill Patients
|
||
Completed |
NCT02589769 -
Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons
|
N/A | |
Completed |
NCT02480504 -
Effects of a 5:2 Diet on Weight Loss and Cardiovascular Risk Factors in Obesity
|
N/A | |
Completed |
NCT03024983 -
Pasta and Other Durum Wheat-based Products: Effects on Post-prandial Glucose Metabolism
|
N/A | |
Recruiting |
NCT02848807 -
Chemotherapy-related Toxicity, Nutritional Status and Quality of Life
|
N/A | |
Completed |
NCT02416284 -
Compliance to the Norwegian Food-Based Dietary Guidelines in Young Females
|
N/A | |
Completed |
NCT01559896 -
Egg Protein Hydrolysate and Vascular Function
|
N/A | |
Terminated |
NCT01329172 -
Nasal Mucin Oral Supplementation Treatment Respiratory Inflammation Using PUFA in Cystic Fibrosis (CF) Patients
|
N/A | |
Completed |
NCT03698929 -
Effect of Dietary Cholesterol on Plasma Lipids
|
N/A | |
Completed |
NCT03942822 -
Chia Supplementation and Non Alcoholic Fatty Liver Disease
|
N/A | |
Completed |
NCT03319836 -
Meeting Protein Targets in Critically Ill Patients
|
||
Completed |
NCT02940197 -
Comparison of Two Calorie Restricted MediterrAsian Diet on Weight Loss in FTO rs9939609 Overweight Carriers
|
N/A | |
Completed |
NCT02811276 -
The Impact of a High Protein Diet on Substrate Oxidation and Energy Metabolism
|
N/A | |
Completed |
NCT02582554 -
Efficacy of Nutrition Risk Screening With NutriSTEP® in Toddlers and Preschoolers
|
N/A | |
Completed |
NCT02274220 -
Feeding Study - Effects Post-cardiac Surgery
|
N/A | |
Completed |
NCT02574052 -
Medical College Students' Responds to Menu Labeling
|
Phase 3 | |
Completed |
NCT02898844 -
Randomized Controlled Experiment of Dieting in Pairs
|
N/A |