Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-04-09 @ 10:59 AM
Study NCT ID:
NCT03079635
Status:
COMPLETED
Last Update Posted:
2017-08-21
First Post:
2017-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breakfast and Energy Expenditure in Young Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-16', 'studyFirstSubmitDate': '2017-03-09', 'studyFirstSubmitQcDate': '2017-03-09', 'lastUpdatePostDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Energy metabolism/expenditure', 'timeFrame': 'Four hours', 'description': 'Energy expenditure and thermic effect of feeding will be measured using a TrueMax 2400 metabolic cart'}], 'secondaryOutcomes': [{'measure': 'Appetite', 'timeFrame': 'Four hours', 'description': 'Postprandial appetite will be assessed using visual analog scales'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to determine if body composition influence the effect of breakfast composition on postprandial (post-meal) hunger, metabolic and energy expenditure response in normal weight, overweight, and obese young women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI over 18.5\n* No medication\n\nExclusion Criteria:\n\n* Food allergies\n* Habitual breakfast skipping (\\> 5 times per week)\n* Picky eater\n* Dietary restrictions'}, 'identificationModule': {'nctId': 'NCT03079635', 'briefTitle': 'Breakfast and Energy Expenditure in Young Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas, Fayetteville'}, 'officialTitle': 'The Effect of Breakfast Intake on Energy Expenditure and Hunger in Young Women', 'orgStudyIdInfo': {'id': '16-09-124'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Normal Weight', 'description': 'This group will be administered two breakfast beverages with a one- to two-week washout period between beverages. The beverages will be a control or an isocaloric, macronutrient matched breakfast beverage with omega-3 fatty acids.', 'interventionNames': ['Dietary Supplement: Control', 'Dietary Supplement: Omega 3 fatty acids']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Overweight and Obese', 'description': 'This group will be administered two breakfast beverages with a one- to two-week washout period between beverages. The beverages will be a control or an isocaloric, macronutrient matched breakfast beverage with omega-3 fatty acids.', 'interventionNames': ['Dietary Supplement: Control', 'Dietary Supplement: Omega 3 fatty acids']}], 'interventions': [{'name': 'Control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Beverage provided and a four hour postprandial assessment of energy metabolism using a metabolic cart and appetite using a visual analog scale follows.', 'armGroupLabels': ['Normal Weight', 'Overweight and Obese']}, {'name': 'Omega 3 fatty acids', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Beverage provided and a four hour postprandial assessment of energy metabolism using a metabolic cart and appetite using a visual analog scale follows.', 'armGroupLabels': ['Normal Weight', 'Overweight and Obese']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72704', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas, Fayetteville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jamie Baum', 'investigatorAffiliation': 'University of Arkansas, Fayetteville'}}}}