- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02820805
Dietary Carbohydrate Consumption on Memory Performance and Mood in Children
August 7, 2017 updated by: Nick Bellissimo, Ryerson University
The Effect of Dietary Carbohydrate Consumption on Memory Performance and Mood in Normal Weight and Overweight/Obese Children
The purpose of this study is to determine the effect of carbohydrates on blood glucose levels, subjective appetite, mood, and memory performance in 9 to 14 year old normal weight (NW) and overweight or obese (OW/OB) children.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
NW and OW/OB children, 9-14 years of age, will participate in the experiment.
The effect of 5 different meals (mashed potatoes, hash browns, French fries, rice, or beans matched by 50g of available carbohydrate) and meal skipping will be examined.
On six separate mornings, one of the meals or no meal will be provided in a random order upon their arrival.
Blood glucose, subjective appetite, and mood will be measured at baseline, 10, 30, 60, 120, and 180 minutes after meal consumption.
Cognitive performance will be measured using an immediate and delayed word recall test, and two to three executive function tasks at 10, 30, 60, 120, and 180 minutes after meal consumption.
Study Type
Interventional
Enrollment (Actual)
22
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
-
-
Ontario
-
Toronto, Ontario, Canada
- School of Nutrition, Ryerson University
-
-
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
9 years to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- be between 9 and 14 years of age
- be healthy, and have been born at term
- be a native English speaker
- not be taking any medications
- not have allergies to potatoes, rice, or beans.
- normal body weight (between the 5th and 85th BMI percentile for age and gender)
- OW/OB (>85th BMI percentile for age and gender)
Exclusion Criteria:
- Food sensitivities, allergies, or dietary restrictions
- Health, learning, emotional, or behaivoural problems
- Receiving any medications
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
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Meal skipping
No meal given
|
No meal
|
Experimental: Mashed potatoes
Carbohydrate Test Meal (50 g of available carbohydrates)
|
50g of available carbohydrates meal
|
Experimental: French fries
Carbohydrate Test Meal (50 g of available carbohydrates)
|
50g of available carbohydrates meal
|
Experimental: Hash browns
Carbohydrate Test Meal (50 g of available carbohydrates)
|
50g of available carbohydrates meal
|
Experimental: Rice
Carbohydrate Test Meal (50 g of available carbohydrates)
|
50g of available carbohydrates meal
|
Experimental: Beans
Carbohydrate Test Meal (50 g of available carbohydrates)
|
50g of available carbohydrates meal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive performance
Time Frame: 10, 30, 60, 120, 180 minutes after meal consumption
|
Participants will participate in a battery of tests that include two learning and memory tasks and two attention tasks at 10, 30, 60, 120, and 180 minutes after meal consumption.
|
10, 30, 60, 120, 180 minutes after meal consumption
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood glucose response
Time Frame: Baseline, 10, 30, 60, 120, and 180 minutes after meal consumption
|
Blood will be collected at baseline, 10, 30, 60, 120, and 180 minutes after meal consumption to observe glycemic responses to 50g available carbohydrates from mashed potatoes, potato pancakes, French fries, rice, or beans
|
Baseline, 10, 30, 60, 120, and 180 minutes after meal consumption
|
Subjective Appetite and Mood
Time Frame: Baseline, 10, 30, 60, 120, and 180 minutes after meal consumption
|
Participants will complete subjective ratings on appetite (e.g., desire to eat, hunger, fullness) and mood (e.g.
anger, happiness, excitement, sleepiness) at baseline, 10, 30, 60, 120, and 180 minutes after meal consumption.
|
Baseline, 10, 30, 60, 120, and 180 minutes after meal consumption
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nick Bellissimo, PhD., Ryerson University
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
April 1, 2016
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
June 27, 2016
First Submitted That Met QC Criteria
June 28, 2016
First Posted (Estimate)
July 1, 2016
Study Record Updates
Last Update Posted (Actual)
August 9, 2017
Last Update Submitted That Met QC Criteria
August 7, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- REB2016-060
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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