NCT02361632

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 12, 2015

Completed
Last Updated

February 18, 2015

Status Verified

January 1, 2015

Enrollment Period

8 months

First QC Date

January 28, 2015

Last Update Submit

February 16, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

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

    "Up to 1 year" asses and proces

Study Arms (3)

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

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

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

Dietary Supplement: Coffee with or without milk

Interventions

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).

Group 1Group 2Group 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Interventions

CoffeeMilk

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesDairy ProductsFood

Study Officials

  • Karin T Beier, MEd

    Aarhus University Hospital Skejby

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2015

First Posted

February 12, 2015

Study Start

August 1, 2013

Primary Completion

April 1, 2014

Study Completion

November 1, 2014

Last Updated

February 18, 2015

Record last verified: 2015-01