Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-01 @ 11:09 AM
Study NCT ID:
NCT01427556
Status:
COMPLETED
Last Update Posted:
2014-08-18
First Post:
2011-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Hormonal and Behavioral Impact of Eating Breakfast
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum and saliva samples will be retained.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-15', 'studyFirstSubmitDate': '2011-08-30', 'studyFirstSubmitQcDate': '2011-08-30', 'lastUpdatePostDateStruct': {'date': '2014-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Food Intake Behavior', 'timeFrame': 'week 6', 'description': 'The goal is to explore the relationship between food intake behavior and the hypothalamic-pituitary axis (HPA) in a group of women who regularly skip breakfast and in another group of women who regularly eat breakfast.'}], 'secondaryOutcomes': [{'measure': 'Markers of nutrient metabolism', 'timeFrame': 'week 6', 'description': 'Blood glucose, insulin, lipids, and metabolic hormones will be measured.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Food intake', 'Breakfast eating'], 'conditions': ['Eating Behavior']}, 'referencesModule': {'references': [{'pmid': '29897486', 'type': 'DERIVED', 'citation': 'Forester SM, Widaman AM, Krishnan S, Witbracht MG, Horn WF, Laugero KD, Keim NL. A Clear Difference Emerges in Hormone Patterns Following a Standard Midday Meal in Young Women Who Regularly Eat or Skip Breakfast. J Nutr. 2018 May 1;148(5):685-692. doi: 10.1093/jn/nxy020.'}]}, 'descriptionModule': {'briefSummary': 'This study is exploring the relationship between food intake behavior and the hypothalamic-pituitary axis (HPA) in women who regularly skip breakfast compared to women who regularly eat breakfast.', 'detailedDescription': 'Healthy women will be studies in a cross-sectional fashion to examine the metabolic, hormonal and behavioral factors associated with breakfast skipping.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'One hundred and twenty pre-menopausal women, aged 20 to 45y, who report eating breakfast regularly or skipping breakfast regularly.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pre-menopausal women (as determined by self-report of menstrual history and confirmation with plasma FSH)\n* 20 to 45 years old,\n* BMI less than 40 kg/m2\n* Stable body weight (fluctuation of less than ± 3%) for past 3 months.\n* Breakfast eaters: defined as eating at least 15% of total daily energy intake at a meal between 0400-1000 h at least 6 days/week.\n* Breakfast skippers: defined as eating no foods or beverages between 0400-1000h at least 4 days/week or only taking beverages (no solid food) containing less than \\~100 kcal.\n\nExclusion Criteria:\n\n* Erratic/intermittent breakfast eating\n* Currently pregnant or lactating\n* Shift workers/diagnosed sleep disorders\n* Use of tobacco products\n* Use of non-prescription drugs/hormone replacement/steroid-based medications\n* Diagnosed endocrine, metabolic, or digestive disorder\n* Hemoglobin \\<11 g/dl\n* Plasma Glucose \\>120 mg/dl'}, 'identificationModule': {'nctId': 'NCT01427556', 'acronym': 'FL-74', 'briefTitle': 'The Hormonal and Behavioral Impact of Eating Breakfast', 'organization': {'class': 'FED', 'fullName': 'USDA, Western Human Nutrition Research Center'}, 'officialTitle': 'CCRC: The Hormonal and Behavioral Impact of Eating Breakfast', 'orgStudyIdInfo': {'id': 'WHNRC 213098-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breakfast Eaters', 'description': 'Women who self-report eating breakfast regularly.'}, {'label': 'Non-Breakfast Eaters', 'description': 'Women who self-report skipping breakfast regularly.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '95616', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'Western Human Nutrition Center, University of California Davis', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}], 'overallOfficials': [{'name': 'Nancy Keim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'WHNRC, ARS, University of California Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'USDA, Western Human Nutrition Research Center', 'class': 'FED'}, 'collaborators': [{'name': 'USDA Beltsville Human Nutrition Research Center', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}