Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2025-12-29 @ 2:47 AM
Study NCT ID:
NCT01530061
Status:
COMPLETED
Last Update Posted:
2022-09-15
First Post:
2012-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Satiating Effect of Eggs in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004531', 'term': 'Eggs'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-13', 'studyFirstSubmitDate': '2012-02-07', 'studyFirstSubmitQcDate': '2012-02-07', 'lastUpdatePostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lunch time food intake', 'timeFrame': '1 day', 'description': 'Measure calories consumed at lunch time.'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale Ratings', 'timeFrame': '1 day', 'description': '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.'}, {'measure': 'Blood appetite hormone', 'timeFrame': '1 day', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Appetite']}, 'descriptionModule': {'briefSummary': 'This study will determine which breakfast (egg breakfast or bagel breakfast) has the most beneficial effect on appetite.', 'detailedDescription': 'Test Day 1 (about 4 hours)\n\n* This is a fasting visit (nothing besides water 12 hours prior to visit)\n* Your child will be offered one of two breakfasts (egg breakfast or bagel breakfast)\n\n . He/she will be asked to eat all the food that is provided.\n* He/she will be asked to rate the taste of the meal.\n* He/she will be offered a pasta lunch.\n\nTest Day 2 (about 4 hours)\n\n* This will be scheduled 1 week after Test Day 1\n* This is a fasting visit (nothing besides water 12 hours prior to visit)\n* 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.\n\nThe sequence of the 2 breakfasts will be randomly assigned to each child.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Is a healthy boy or girl between 14 and 17 years of age\n\n * Is a healthy boy or girl between 4 and 6 years of age\n\nExclusion Criteria:\n\n* • 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\n\n * Has allergies/sensitivities/dislikes to eggs, soy, or wheat\n * Uses drugs recreationally\n * Is actively attempting to lose weight'}, 'identificationModule': {'nctId': 'NCT01530061', 'briefTitle': 'The Satiating Effect of Eggs in Children', 'organization': {'class': 'OTHER', 'fullName': 'Pennington Biomedical Research Center'}, 'officialTitle': 'The Satiating Effect of Eggs in Children', 'orgStudyIdInfo': {'id': 'PBRC 12001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Preschool Children age 4-6 years', 'description': 'Preschool children participate in eating either an egg breakfast or a bagel breakfast.', 'interventionNames': ['Other: Egg Breakfast', 'Other: Bagel Breakfast']}, {'type': 'EXPERIMENTAL', 'label': 'Teenagers 14-17 years of age', 'description': 'Teenagers participate in eating either an egg breakfast or a bagel breakfast.', 'interventionNames': ['Other: Egg Breakfast', 'Other: Bagel Breakfast']}], 'interventions': [{'name': 'Egg Breakfast', 'type': 'OTHER', 'otherNames': ['Egg'], 'description': 'Egg, Toast and Jelly', 'armGroupLabels': ['Preschool Children age 4-6 years', 'Teenagers 14-17 years of age']}, {'name': 'Bagel Breakfast', 'type': 'OTHER', 'otherNames': ['Bagel'], 'description': 'Bagel, Cream Cheese and Yogurt', 'armGroupLabels': ['Preschool Children age 4-6 years', 'Teenagers 14-17 years of age']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}], 'overallOfficials': [{'name': 'Nikhil Dhurandhar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pennington Biomedical Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Egg Nutrition Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}