The Satiating Effect of Eggs in Children

Study Overview
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Brief Summary
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This study will determine which breakfast (egg breakfast or bagel breakfast) has the most beneficial effect on appetite.

Detailed Description
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Test Day 1 (about 4 hours) This is a fasting visit (nothing besides water 12 hours prior to visit) Your child will be offered one of two breakfasts (egg breakfast or bagel breakfast) . He/she will be asked to eat all the food that is provided. He/she will be asked to rate the taste of the meal. He/she will be offered a pasta lunch. Test Day 2 (about 4 hours) This will be scheduled 1 week after Test Day 1 This is a fasting visit (nothing besides water 12 hours prior to visit) The procedures for this visit are the same as for Test Day 1. Your child will be offered the breakfast that he/she did not receive at the last visit. The sequence of the 2 breakfasts will be randomly assigned to each child.

Official Title
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The Satiating Effect of Eggs in Children

Conditions
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Appetite

Intervention / Treatment
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* Other: Egg Breakfast
* Other: Bagel Breakfast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Is a healthy boy or girl between 14 and 17 years of age Is a healthy boy or girl between 4 and 6 years of age Exclusion Criteria: • Is suffering from any diseases such as major heart conditions, type 1 diabetes, cancer, eating disorders, or any serious illness that requires intensive and long-term medical treatment Has allergies/sensitivities/dislikes to eggs, soy, or wheat Uses drugs recreationally Is actively attempting to lose weight

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preschool Children age 4-6 years<br>Preschool children participate in eating either an egg breakfast or a bagel breakfast. | Other: Egg Breakfast<br>* Egg, Toast and Jelly<br>* Other names: Egg;Other: Bagel Breakfast<br>* Bagel, Cream Cheese and Yogurt<br>* Other names: Bagel;|
| Experimental: Teenagers 14-17 years of age<br>Teenagers participate in eating either an egg breakfast or a bagel breakfast. | Other: Egg Breakfast<br>* Egg, Toast and Jelly<br>* Other names: Egg;Other: Bagel Breakfast<br>* Bagel, Cream Cheese and Yogurt<br>* Other names: Bagel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lunch time food intake | Measure calories consumed at lunch time. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale Ratings | They will be asked to rate their feelings of hunger and fullness periodically using visual analog scales. The Egg Breakfast is expected to increase satiety scores, decrease hunger and the lunch time food intake, compared to the Bagel Breakfast. | 1 day | 
| Blood appetite hormone | We expect that Peptide YY (PYY) and Glucagon-like Peptide-1 (GLP1) levels will rise higher and remain elevated after the Egg Breakfast, and the acylated ghrelin levels will rise higher between the Bagle Breakfast and lunch time. | 1 day |