Does Adding Milk to Coffee Change Gastric Volume?

NCT ID: NCT02361632

Last Updated: 2015-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Aspiration of Gastric Content

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

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

Group Type EXPERIMENTAL

Coffee with or without milk

Intervention Type DIETARY_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).

Group 2

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

Group Type EXPERIMENTAL

Coffee with or without milk

Intervention Type DIETARY_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).

Group 3

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

Group Type EXPERIMENTAL

Coffee with or without milk

Intervention Type DIETARY_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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Coffee with or without milk

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).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy volunteers

Exclusion Criteria

* Former or present gastric history, pregnancy, claustrophobia, metal implants
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aarhus University Hospital Skejby

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Karin T Beier, MEd

Role: STUDY_CHAIR

Aarhus University Hospital Skejby

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 27035595 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MK

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Human Milk in Preterm Infants
NCT05228535 UNKNOWN NA