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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02820805
Other study ID # REB2016-060
Secondary ID
Status Completed
Phase N/A
First received June 27, 2016
Last updated August 7, 2017
Start date April 2016
Est. completion date October 2016

Study information

Verified date August 2017
Source Ryerson University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 14 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Meal Skipping
No meal
French fries
50g of available carbohydrates meal
Mashed potatoes
50g of available carbohydrates meal
Hash browns
50g of available carbohydrates meal
Rice
50g of available carbohydrates meal
Beans
50g of available carbohydrates meal

Locations

Country Name City State
Canada School of Nutrition, Ryerson University Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Ryerson University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cognitive performance 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 Blood glucose response 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
Secondary Subjective Appetite and Mood 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
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