Verified July 2016 by Ryerson University
Sponsor:
Information provided by (Responsible Party):
Nick Bellissimo, Ryerson University
ClinicalTrials.gov Identifier:
NCT02820805
First received: June 27, 2016
Last updated: July 25, 2016
Last verified: July 2016
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.
| Cognitive Ability, General | Other: Meal Skipping Other: French fries Other: Mashed potatoes Other: Hash browns Other: Rice Other: Beans |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | The Effect of Dietary Carbohydrate Consumption on Memory Performance and Mood in Normal Weight and Overweight/Obese Children |
- Cognitive performance [ Time Frame: 10, 30, 60, 120, 180 minutes after meal consumption ] [ Designated as safety issue: No ]
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.
- Blood glucose response [ Time Frame: Baseline, 10, 30, 60, 120, and 180 minutes after meal consumption ] [ Designated as safety issue: No ]
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
- Subjective Appetite and Mood [ Time Frame: Baseline, 10, 30, 60, 120, and 180 minutes after meal consumption ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2016 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | October 2016 (Final data collection date for primary outcome measure) |
| Experimental: Meal skipping
No meal given |
Other: Meal Skipping
No meal |
| Experimental: Mashed potatoes
Carbohydrate Test Meal (50 g of available carbohydrates) |
Other: Mashed potatoes
50g of available carbohydrates meal |
| Experimental: French fries
Carbohydrate Test Meal (50 g of available carbohydrates) |
Other: French fries
50g of available carbohydrates meal |
| Experimental: Hash browns
Carbohydrate Test Meal (50 g of available carbohydrates) |
Other: Hash browns
50g of available carbohydrates meal |
| Experimental: Rice
Carbohydrate Test Meal (50 g of available carbohydrates) |
Other: Rice
50g of available carbohydrates meal |
| Experimental: Beans
Carbohydrate Test Meal (50 g of available carbohydrates) |
Other: Beans
50g of available carbohydrates meal |
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.
| Ages Eligible for Study: | 9 Years to 14 Years (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02820805
| School of Nutrition, Ryerson University | |
| Toronto, Ontario, Canada | |
| Contact: Nick Bellissimo, PhD 416 979 5000 ext 3026 nick.bellissimo@nullryerson.ca | |
| Principal Investigator: Nick Bellissimo, PhD | |
Ryerson University
| Principal Investigator: | Nick Bellissimo, PhD. | Ryerson University |
| Responsible Party: | Nick Bellissimo, Associate Professor, School of Nutrition, Ryerson University |
| ClinicalTrials.gov Identifier: | NCT02820805 History of Changes |
| Other Study ID Numbers: | REB2010-060 |
| Study First Received: | June 27, 2016 |
| Last Updated: | July 25, 2016 |
| Health Authority: | Canada: Ethics Review Committee |
| Individual Participant Data | |
| Plan to Share IPD: | Undecided |
Keywords provided by Ryerson University:
| children dietary carbohydrates solanum tuberosum cognition |
memory emotions blood glucose |
ClinicalTrials.gov processed this record on August 25, 2016