- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02361632
Does Adding Milk to Coffee Change Gastric Volume?
February 16, 2015 updated by: University of Aarhus
The intention of this study is to determine wether coffee added milk change gastric volume in comparison with gastric volume after drinking black coffee
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy volunteers
Exclusion Criteria:
- Former or present gastric history, pregnancy, claustrophobia, metal implants
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
Dietary Supplement. Participants drink coffee with or without milk in following order:
|
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).
|
Experimental: Group 2
Dietary supplement. Participants drink coffee with or without milk in following order:
|
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).
|
Experimental: Group 3
Dietary supplement. Participants drink coffee with or without milk in following order:
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in gastric volume after 175 ml coffee with 20% full fat milk compared with gastric volume after 175 ml black coffee .
Time Frame: "Up to 1 year" asses and proces
|
"Up to 1 year" asses and proces
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in gastric volume after 175 ml coffee with 50% full fat milk compared with gastric volume after 175 ml black coffee
Time Frame: "Up to 1 year" asses and proces
|
"Up to 1 year" asses and proces
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Karin T Beier, MEd, Aarhus University Hospital Skejby
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
January 28, 2015
First Submitted That Met QC Criteria
February 6, 2015
First Posted (Estimate)
February 12, 2015
Study Record Updates
Last Update Posted (Estimate)
February 18, 2015
Last Update Submitted That Met QC Criteria
February 16, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Respiratory Tract Diseases
- Respiration Disorders
- Gastrointestinal Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Gastroesophageal Reflux
- Laryngopharyngeal Reflux
- Respiratory Aspiration
- Respiratory Aspiration of Gastric Contents
Other Study ID Numbers
- MK
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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