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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03045354
Other study ID # REB2016-227
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2016
Est. completion date September 2017

Study information

Verified date July 2018
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 of familiar breakfast meals on glycemic response, subjective appetite, and food intake in normal weight (NW) and overweight or obese (OW/OB) children.


Description:

Regular breakfast eating NW and OW/OB children, 9-14 years of age, will participate in the experiment. Four isocaloric (450 kcal) breakfasts (eggs with a side of French fries, mashed potatoes, or beans, and control breakfast of milk, cereal and toast) and breakfast skipping will be examined. On five separate mornings, 7 days apart and after a 12 hour overnight fast, each participant will receive one of the four breakfasts or skip breakfast, in a randomized counterbalanced order. Participants will be given an ad libitum lunch 3 hours after breakfast and parents will report the rest of day food record for food intake analysis. Blood glucose will be measured via finger-prick at baseline, and 30, 60, 120, and 180 minutes after breakfast consumption. Subjective appetite will be measured with a visual analogue scale at baseline and every 15 minutes for 1 hour, and every hour for 3 hours.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date September 2017
Est. primary completion date June 2017
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

- not be taking any medications

- not have allergies or sensitivities to potatoes, eggs, gluten, dairy, or beans

- NW (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 behavioural problems

- receiving any medications

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mashed potatoes
Isocaloric (450 kcal) breakfast treatments of eggs with a side of mashed potatoes
Traditional breakfast
Isocaloric (450 kcal) control breakfast treatments of cereal, milk, toast and jam
Breakfast skipping
No breakfast
French fries
Isocaloric (450 kcal) breakfast treatments of eggs with a side of French fries
Beans
Isocaloric (450 kcal) breakfast treatments of eggs with a side of beans

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 Short-term food intake (kcal) Participants will consume an ad libitum lunch 3 hours post breakfast consumption. 3 hours after breakfast
Secondary Subjective appetite Participants will complete subjective ratings on appetite and well-being Baseline, at 15 or 60 minutes intervals for 3 hours
Secondary Blood glucose Finger prick capillary blood glucose will be collected Baseline, 30, 60, 120 and 180 minutes after breakfast
Secondary Rest of day food record Parents/guardians will record participants' food intake until the end of the day 8-12 hours
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