Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-01-01 @ 10:14 AM
Study NCT ID:
NCT02361632
Status:
COMPLETED
Last Update Posted:
2015-02-18
First Post:
2015-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Adding Milk to Coffee Change Gastric Volume?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003069', 'term': 'Coffee'}, {'id': 'D008892', 'term': 'Milk'}], 'ancestors': [{'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-16', 'studyFirstSubmitDate': '2015-01-28', 'studyFirstSubmitQcDate': '2015-02-06', 'lastUpdatePostDateStruct': {'date': '2015-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in gastric volume after 175 ml coffee with 20% full fat milk compared with gastric volume after 175 ml black coffee .', 'timeFrame': '"Up to 1 year" asses and proces'}], 'secondaryOutcomes': [{'measure': 'Change in gastric volume after 175 ml coffee with 50% full fat milk compared with gastric volume after 175 ml black coffee', 'timeFrame': '"Up to 1 year" asses and proces'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Respiratory Aspiration of Gastric Content']}, 'referencesModule': {'references': [{'pmid': '27035595', 'type': 'DERIVED', 'citation': 'Larsen B, Larsen LP, Sivesgaard K, Juul S. Black or white coffee before anaesthesia?: A randomised crossover trial. Eur J Anaesthesiol. 2016 Jun;33(6):457-62. doi: 10.1097/EJA.0000000000000457.'}]}, 'descriptionModule': {'briefSummary': 'The intention of this study is to determine wether coffee added milk change gastric volume in comparison with gastric volume after drinking black coffee', 'detailedDescription': 'Thirty participants - divided in tree groups - drink coffee with or without milk after six hours fast for solid food. Each group drinks both coffee with or without milk in different order. Two hours after drinking coffee gastric volume is measured by Magnetic Resonance Imagining.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers\n\nExclusion Criteria:\n\n* Former or present gastric history, pregnancy, claustrophobia, metal implants'}, 'identificationModule': {'nctId': 'NCT02361632', 'briefTitle': 'Does Adding Milk to Coffee Change Gastric Volume?', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Does Adding Milk to Coffee Change Gastric Volume?', 'orgStudyIdInfo': {'id': 'MK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Dietary Supplement. Participants drink coffee with or without milk in following order:\n\n1. Black coffee\n2. Coffee with 20% milk added\n3. Coffee with 50% milk added', 'interventionNames': ['Dietary Supplement: Coffee with or without milk']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Dietary supplement. Participants drink coffee with or without milk in following order:\n\n1. Coffee with 20% milk added\n2. Black coffee\n3. Coffee with 50% milk added', 'interventionNames': ['Dietary Supplement: Coffee with or without milk']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'Dietary supplement. Participants drink coffee with or without milk in following order:\n\n1. Black coffee\n2. Coffee with 50% milk added\n3. Coffee with 20% milk added', 'interventionNames': ['Dietary Supplement: Coffee with or without milk']}], 'interventions': [{'name': 'Coffee with or without milk', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Intervention :30 participants were randomized to 3 Groups, 10 persons in each group. All participants fasted 6 hours for solid food before gastric volume was measured by Magnetic Resonance Imagining ( MRI). 2 hours before MRI examination, each participant ingested either 175 ml black coffee, 175 ml coffee with 20% milk or 175 ml coffee with 50% milk in the order defined for the group (arm).', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Karin T Beier, MEd', 'role': 'STUDY_CHAIR', 'affiliation': 'Aarhus University Hospital Skejby'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital Skejby', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}