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Does Adding Milk to Coffee Change Gastric Volume?

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ClinicalTrials.gov Identifier: NCT02361632
Recruitment Status : Completed
First Posted : February 12, 2015
Last Update Posted : February 18, 2015
Sponsor:
Collaborator:
Aarhus University Hospital Skejby
Information provided by (Responsible Party):
University of Aarhus

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

Condition or disease Intervention/treatment Phase
Respiratory Aspiration of Gastric Content Dietary Supplement: Coffee with or without milk Not Applicable

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  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Adding Milk to Coffee Change Gastric Volume?
Study Start Date : August 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
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).

Experimental: 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
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).

Experimental: 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
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).




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361632


Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital Skejby
Investigators
Study Chair: Karin T Beier, MEd Aarhus University Hospital Skejby

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02361632     History of Changes
Other Study ID Numbers: MK
First Posted: February 12, 2015    Key Record Dates
Last Update Posted: February 18, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Respiratory Aspiration
Respiratory Aspiration of Gastric Contents
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Laryngopharyngeal Reflux
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases