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Dietary Carbohydrate Consumption at Breakfast on Food Intake, Glycemic Response, and Subjective Appetite

Primary Purpose

Childhood Obesity, Breakfast

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mashed potatoes
Traditional breakfast
Breakfast skipping
French fries
Beans
Sponsored by
Toronto Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring children, dietary carbohydrates, satiety, appetite, blood glucose, solanum tuberosum, obesity, breakfast

Eligibility Criteria

9 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • School of Nutrition, Ryerson University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Mashed potatoes

French fries

Beans

Traditional breakfast

Breakfast skipping

Arm Description

Eggs with a side of mashed potatoes

Eggs with a side of French fries

Eggs with a side of beans

Cereal, milk, toast and jam

No breakfast

Outcomes

Primary Outcome Measures

Short-term food intake (kcal)
Participants will consume an ad libitum lunch 3 hours post breakfast consumption.

Secondary Outcome Measures

Subjective appetite
Participants will complete subjective ratings on appetite and well-being
Blood glucose
Finger prick capillary blood glucose will be collected
Rest of day food record
Parents/guardians will record participants' food intake until the end of the day

Full Information

First Posted
February 3, 2017
Last Updated
July 19, 2018
Sponsor
Toronto Metropolitan University
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1. Study Identification

Unique Protocol Identification Number
NCT03045354
Brief Title
Dietary Carbohydrate Consumption at Breakfast on Food Intake, Glycemic Response, and Subjective Appetite
Official Title
The Effect of Carbohydrate-Containing Foods at Breakfast on Food Intake, Glycemic Response, and Subjective Appetite in Normal Weight and Overweight/Obese Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Toronto Metropolitan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity, Breakfast
Keywords
children, dietary carbohydrates, satiety, appetite, blood glucose, solanum tuberosum, obesity, breakfast

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mashed potatoes
Arm Type
Experimental
Arm Description
Eggs with a side of mashed potatoes
Arm Title
French fries
Arm Type
Experimental
Arm Description
Eggs with a side of French fries
Arm Title
Beans
Arm Type
Experimental
Arm Description
Eggs with a side of beans
Arm Title
Traditional breakfast
Arm Type
Experimental
Arm Description
Cereal, milk, toast and jam
Arm Title
Breakfast skipping
Arm Type
Experimental
Arm Description
No breakfast
Intervention Type
Other
Intervention Name(s)
Mashed potatoes
Intervention Description
Isocaloric (450 kcal) breakfast treatments of eggs with a side of mashed potatoes
Intervention Type
Other
Intervention Name(s)
Traditional breakfast
Intervention Description
Isocaloric (450 kcal) control breakfast treatments of cereal, milk, toast and jam
Intervention Type
Other
Intervention Name(s)
Breakfast skipping
Intervention Description
No breakfast
Intervention Type
Other
Intervention Name(s)
French fries
Intervention Description
Isocaloric (450 kcal) breakfast treatments of eggs with a side of French fries
Intervention Type
Other
Intervention Name(s)
Beans
Intervention Description
Isocaloric (450 kcal) breakfast treatments of eggs with a side of beans
Primary Outcome Measure Information:
Title
Short-term food intake (kcal)
Description
Participants will consume an ad libitum lunch 3 hours post breakfast consumption.
Time Frame
3 hours after breakfast
Secondary Outcome Measure Information:
Title
Subjective appetite
Description
Participants will complete subjective ratings on appetite and well-being
Time Frame
Baseline, at 15 or 60 minutes intervals for 3 hours
Title
Blood glucose
Description
Finger prick capillary blood glucose will be collected
Time Frame
Baseline, 30, 60, 120 and 180 minutes after breakfast
Title
Rest of day food record
Description
Parents/guardians will record participants' food intake until the end of the day
Time Frame
8-12 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick Bellissimo, PhD
Organizational Affiliation
Toronto Metropolitan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Nutrition, Ryerson University
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 2K3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Dietary Carbohydrate Consumption at Breakfast on Food Intake, Glycemic Response, and Subjective Appetite

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