NCT07214909

Brief Summary

To determine the gastric emptying time for clear liquids at different volumes in the adult population, for use in determining anesthesia guidelines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

January 18, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 9, 2025

Completed
Last Updated

October 9, 2025

Status Verified

October 1, 2025

Enrollment Period

1.9 years

First QC Date

October 2, 2025

Last Update Submit

October 8, 2025

Conditions

Keywords

Gastric emptying time

Outcome Measures

Primary Outcomes (1)

  • Gastric emptying times of liquids at set volumes.

    Study participants have a baseline ultrasound to confirm if stomach was empty and then have scans every hour after ingesting coffee until stomach was empty (Grade 0) or 4 hours maximum, whichever occurs first.

Study Arms (2)

Coffee

ACTIVE COMPARATOR

Study participants ingested black coffee

Other: Ingesting coffee without creamer

Coffee with creamer

EXPERIMENTAL

Study participants ingested coffee with creamer

Other: Ingesting coffee with creamer

Interventions

Ingesting coffee without creamer and evaluating gastric emptying with gastric ultrasound at different time points.

Coffee

Ingesting coffee with creamer and evaluating gastric emptying with gastric ultrasound at different time points.

Coffee with creamer

Eligibility Criteria

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

You may qualify if:

  • Age 18-65
  • Able to provide informed consent and verbally disclose their medical history in English. The study staff will not be accessing the subjects electronic medical record to verify the criteria.

You may not qualify if:

  • Daily medications excluding oral contraceptives
  • Medical conditions affecting gastric emptying, including diabetes, known gastric condition, prior gastric surgery, or pregnancy
  • Inability to tolerate 7 hours of fasting
  • Non-empty gastric antrum on baseline ultrasound

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MetroHealthMC

Cleveland, Ohio, 44109, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Individual performing the gastric ultrasound was blinded as to which arm the study participants were in.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Once eligibility was established, participants were randomly divided into 2 groups: one group assigned to drink 16 ounces of cold black coffee without creamer and the other group assigned to drink 16 ounces of cold black coffee with two standard creamer pods (0.76 oz) added. Randomization was generated by alternating participants between receiving black coffee or coffee with creamer after they had been consented for the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emergency Medicine Physician

Study Record Dates

First Submitted

October 2, 2025

First Posted

October 9, 2025

Study Start

January 18, 2023

Primary Completion

December 9, 2024

Study Completion

December 9, 2024

Last Updated

October 9, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations