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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

Primary Outcome Measures:

  • 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.

Secondary Outcome Measures:

  • 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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