Does Adding Milk to Coffee Change Gastric Volume?
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
The intention of this study is to determine wether coffee added milk change gastric volume in comparison with gastric volume after drinking black coffee
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 28, 2015
CompletedFirst Posted
Study publicly available on registry
February 12, 2015
CompletedFebruary 18, 2015
January 1, 2015
8 months
January 28, 2015
February 16, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change in gastric volume after 175 ml coffee with 20% full fat milk compared with gastric volume after 175 ml black coffee .
"Up to 1 year" asses and proces
Secondary Outcomes (1)
Change in gastric volume after 175 ml coffee with 50% full fat milk compared with gastric volume after 175 ml black coffee
"Up to 1 year" asses and proces
Study Arms (3)
Group 1
EXPERIMENTALDietary Supplement. Participants drink coffee with or without milk in following order: 1. Black coffee 2. Coffee with 20% milk added 3. Coffee with 50% milk added
Group 2
EXPERIMENTALDietary supplement. Participants drink coffee with or without milk in following order: 1. Coffee with 20% milk added 2. Black coffee 3. Coffee with 50% milk added
Group 3
EXPERIMENTALDietary supplement. Participants drink coffee with or without milk in following order: 1. Black coffee 2. Coffee with 50% milk added 3. Coffee with 20% milk added
Interventions
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).
Eligibility Criteria
You may qualify if:
- Healthy volunteers
You may not qualify if:
- Former or present gastric history, pregnancy, claustrophobia, metal implants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Aarhus University Hospital Skejbycollaborator
Related Publications (1)
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.
PMID: 27035595DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Karin T Beier, MEd
Aarhus University Hospital Skejby
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2015
First Posted
February 12, 2015
Study Start
August 1, 2013
Primary Completion
April 1, 2014
Study Completion
November 1, 2014
Last Updated
February 18, 2015
Record last verified: 2015-01