The Satiating Effect of Eggs in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Pennington Biomedical Research Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Egg Nutrition Center
Information provided by (Responsible Party):
Nikhil Dhurandhar, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01530061
First received: February 7, 2012
Last updated: August 16, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention
Appetite
Other: Egg Breakfast
Other: Bagel Breakfast

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Satiating Effect of Eggs in Children

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Lunch time food intake [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Measure calories consumed at lunch time.


Secondary Outcome Measures:
  • Visual Analog Scale Ratings [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.

  • Blood appetite hormone [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: February 2012
Estimated Study Completion Date: April 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Preschool Children age 4-6 years
Preschool children participate in eating either an egg breakfast or a bagel breakfast.
Other: Egg Breakfast
Egg, Toast and Jelly
Other Name: Egg
Other: Bagel Breakfast
Bagel, Cream Cheese and Yogurt
Other Name: Bagel
Experimental: Teenagers 14-17 years of age
Teenagers participate in eating either an egg breakfast or a bagel breakfast.
Other: Egg Breakfast
Egg, Toast and Jelly
Other Name: Egg
Other: Bagel Breakfast
Bagel, Cream Cheese and Yogurt
Other Name: Bagel

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.

  Eligibility

Ages Eligible for Study:   4 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530061

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Egg Nutrition Center
Investigators
Principal Investigator: Nikhil Dhurandhar, PhD Pennington Biomedical Research Center
  More Information

No publications provided

Responsible Party: Nikhil Dhurandhar, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01530061     History of Changes
Other Study ID Numbers: PBRC12001
Study First Received: February 7, 2012
Last Updated: August 16, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 20, 2014