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

Study Overview
=================
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.

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

Conditions
-----------------
Childhood Obesity, Breakfast

Intervention / Treatment
-----------------
* Other: Mashed potatoes
* Other: Traditional breakfast
* Other: Breakfast skipping
* Other: French fries
* Other: Beans


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mashed potatoes<br>Eggs with a side of mashed potatoes | Other: Mashed potatoes<br>* Isocaloric (450 kcal) breakfast treatments of eggs with a side of mashed potatoes<br>|
| Experimental: French fries<br>Eggs with a side of French fries | Other: French fries<br>* Isocaloric (450 kcal) breakfast treatments of eggs with a side of French fries<br>|
| Experimental: Beans<br>Eggs with a side of beans | Other: Beans<br>* Isocaloric (450 kcal) breakfast treatments of eggs with a side of beans<br>|
| Experimental: Traditional breakfast<br>Cereal, milk, toast and jam | Other: Traditional breakfast<br>* Isocaloric (450 kcal) control breakfast treatments of cereal, milk, toast and jam<br>|
| Experimental: Breakfast skipping<br>No breakfast | Other: Breakfast skipping<br>* No breakfast<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term food intake (kcal) | 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 | Participants will complete subjective ratings on appetite and well-being | Baseline, at 15 or 60 minutes intervals for 3 hours | 
| Blood glucose | Finger prick capillary blood glucose will be collected | Baseline, 30, 60, 120 and 180 minutes after breakfast | 
| Rest of day food record | Parents/guardians will record participants' food intake until the end of the day | 8-12 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
children, dietary carbohydrates, satiety, appetite, blood glucose, solanum tuberosum, obesity, breakfast