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Does Adding Milk to Coffee Change Gastric Volume?

Primary Purpose

Respiratory Aspiration of Gastric Content

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Coffee with or without milk

Sponsored by

University of Aarhus

About this trial

This is an interventional prevention trial for Respiratory Aspiration of Gastric Content

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy volunteers

Exclusion Criteria:

Former or present gastric history, pregnancy, claustrophobia, metal implants

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

Dietary Supplement. Participants drink coffee with or without milk in following order: Black coffee Coffee with 20% milk added Coffee with 50% milk added

Dietary supplement. Participants drink coffee with or without milk in following order: Coffee with 20% milk added Black coffee Coffee with 50% milk added

Dietary supplement. Participants drink coffee with or without milk in following order: Black coffee Coffee with 50% milk added Coffee with 20% milk added

Outcomes

Primary Outcome Measures

Change in gastric volume after 175 ml coffee with 20% full fat milk compared with gastric volume after 175 ml black coffee .

Secondary Outcome Measures

Change in gastric volume after 175 ml coffee with 50% full fat milk compared with gastric volume after 175 ml black coffee

Full Information

NCT ID

First Posted

January 28, 2015

Last Updated

February 16, 2015

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital Skejby

1. Study Identification

Unique Protocol Identification Number

NCT02361632

Brief Title

Does Adding Milk to Coffee Change Gastric Volume?

Official Title

Does Adding Milk to Coffee Change Gastric Volume?

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

August 2013 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital Skejby

4. Oversight

Data Monitoring Committee

No

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Aspiration of Gastric Content

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Dietary Supplement. Participants drink coffee with or without milk in following order: Black coffee Coffee with 20% milk added Coffee with 50% milk added

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Dietary supplement. Participants drink coffee with or without milk in following order: Coffee with 20% milk added Black coffee Coffee with 50% milk added

Arm Title

Group 3

Arm Type

Experimental

Arm Description

Dietary supplement. Participants drink coffee with or without milk in following order: Black coffee Coffee with 50% milk added Coffee with 20% milk added

Intervention Type

Dietary Supplement

Intervention Name(s)

Coffee with or without milk

Intervention 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).

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy volunteers Exclusion Criteria: Former or present gastric history, pregnancy, claustrophobia, metal implants

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karin T Beier, MEd

Organizational Affiliation

Aarhus University Hospital Skejby

Official's Role

Study Chair

12. IPD Sharing Statement

Citations:

PubMed Identifier

27035595

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.

Results Reference

derived

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Does Adding Milk to Coffee Change Gastric Volume?

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