- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03045354
Dietary Carbohydrate Consumption at Breakfast on Food Intake, Glycemic Response, and Subjective Appetite
July 19, 2018 updated by: Nick Bellissimo, Ryerson University
The Effect of Carbohydrate-Containing Foods at Breakfast on Food Intake, Glycemic Response, and Subjective Appetite in Normal Weight and Overweight/Obese Children
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
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, M5B 2K3
- 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
Yes
Genders Eligible for Study
All
Description
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 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: Mashed potatoes
Eggs with a side of mashed potatoes
|
Isocaloric (450 kcal) breakfast treatments of eggs with a side of mashed potatoes
|
|
Experimental: French fries
Eggs with a side of French fries
|
Isocaloric (450 kcal) breakfast treatments of eggs with a side of French fries
|
|
Experimental: Beans
Eggs with a side of beans
|
Isocaloric (450 kcal) breakfast treatments of eggs with a side of beans
|
|
Experimental: Traditional breakfast
Cereal, milk, toast and jam
|
Isocaloric (450 kcal) control breakfast treatments of cereal, milk, toast and jam
|
|
Experimental: Breakfast skipping
No breakfast
|
No breakfast
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short-term food intake (kcal)
Time Frame: 3 hours after breakfast
|
Participants will consume an ad libitum lunch 3 hours post breakfast consumption.
|
3 hours after breakfast
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective appetite
Time Frame: Baseline, at 15 or 60 minutes intervals for 3 hours
|
Participants will complete subjective ratings on appetite and well-being
|
Baseline, at 15 or 60 minutes intervals for 3 hours
|
|
Blood glucose
Time Frame: Baseline, 30, 60, 120 and 180 minutes after breakfast
|
Finger prick capillary blood glucose will be collected
|
Baseline, 30, 60, 120 and 180 minutes after breakfast
|
|
Rest of day food record
Time Frame: 8-12 hours
|
Parents/guardians will record participants' food intake until the end of the day
|
8-12 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
October 1, 2016
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
September 1, 2017
Study Registration Dates
First Submitted
February 3, 2017
First Submitted That Met QC Criteria
February 3, 2017
First Posted (Estimate)
February 7, 2017
Study Record Updates
Last Update Posted (Actual)
July 23, 2018
Last Update Submitted That Met QC Criteria
July 19, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB2016-227
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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