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

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.

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

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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