- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01530061
The Satiating Effect of Eggs in Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Preschool Children age 4-6 years
Preschool children participate in eating either an egg breakfast or a bagel breakfast.
|
Egg, Toast and Jelly
Other Names:
Bagel, Cream Cheese and Yogurt
Other Names:
|
|
EXPERIMENTAL: Teenagers 14-17 years of age
Teenagers participate in eating either an egg breakfast or a bagel breakfast.
|
Egg, Toast and Jelly
Other Names:
Bagel, Cream Cheese and Yogurt
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lunch time food intake
Time Frame: 1 day
|
Measure calories consumed at lunch time.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale Ratings
Time Frame: 1 day
|
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
Time Frame: 1 day
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Nikhil Dhurandhar, PhD, Pennington Biomedical Research Center
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PBRC 12001
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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