Respiratory Aspiration of Gastric ContentNCT02361632
Does Adding Milk to Coffee Change Gastric Volume?
A study testing Coffee with or without milk in people with Respiratory Aspiration of Gastric Content, run by University of Aarhus.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Aspiration of Gastric Content
- What is being tested?
- Coffee with or without milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
Who cannot join
- Former or present gastric history, pregnancy, claustrophobia, metal implants
About this study
The intention of this study is to determine wether coffee added milk change gastric volume in comparison with gastric volume after drinking black coffee
Read the 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.
- Being tested
- Coffee with or without milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coffee with or without milkDietary supplement
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).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Dietary 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 Receives: Dietary Supplement: Coffee with or without milk |
| Group 2 | Experimental | Dietary 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 Receives: Dietary Supplement: Coffee with or without milk |
| Group 3 | Experimental | Dietary 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 Receives: Dietary Supplement: Coffee with or without milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gastric volume after 175 ml coffee with 20% full fat milk compared with gastric volume after 175 ml black coffee .
Measured: "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
Measured: "Up to 1 year" asses and proces
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startAug 2013
- Primary completionApr 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Aspiration of Gastric ContentStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital Skejby
- Responsible party
- Sponsor
- Investigators
- Karin T Beier, MEd, Study chair, Aarhus University Hospital Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361632
- Sponsor's protocol ID
- MK
- Status last verified
- Jan 2015
- First submitted
- 28 Jan 2015
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27035595
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Adding Milk to Coffee Change Gastric Volume?
- ClinicalTrials.gov ID
- NCT02361632
- Acronym / sponsor ID
- MK
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital Skejby
- Study start
- Aug 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 12 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The intention of this study is to determine wether coffee added milk change gastric volume in comparison with gastric volume after drinking black coffee
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Dietary Supplement: Coffee with or without milkDietary 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 | Experimental | Dietary Supplement: Coffee with or without milkDietary 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 | Experimental | Dietary Supplement: Coffee with or without milkDietary 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (1 listed)
- Former or present gastric history, pregnancy, claustrophobia, metal implants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coffee with or without milkIntervention :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). | Dietary supplement | Group 1, Group 2, Group 3 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
- Derived from this study: PubMed 27035595Larsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin T Beier, MEd study chair
Aarhus University Hospital Skejby
Questions about this trial
What is this clinical trial studying?
A study testing Coffee with or without milk in people with Respiratory Aspiration of Gastric Content, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02361632, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2015.