Does Adding Milk to Coffee Change Gastric Volume?

Respiratory Aspiration of Gastric Content Clinical Trial

Official title:

Does Adding Milk to Coffee Change Gastric Volume?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361632
• Other study ID #: MK
• Status: Completed
• Phase: N/A
• First received: January 28, 2015
• Last updated: February 16, 2015
• Start date: August 2013
• Est. completion date: November 2014

Study information

• Verified date: January 2015
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy volunteers

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Respiratory Aspiration
• Respiratory Aspiration of Gastric Content
• Respiratory Aspiration of Gastric Contents

Intervention

Dietary Supplement:
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital Skejby

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes