An interventional study of Addition of half and half to coffee and Addition of non-dairy creamer to coffee in Anesthesia, Aspiration and Fasting, sponsored by University of Arkansas. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-23.
Sponsored by University of Arkansas · Not applicable, Interventional, and Basic science
Undergoing anesthesia requires patients to fast pre-operatively to allow the stomach to empty and prevent aspiration pneumonia but patients are allowed to drink "clear" liquids up to 2 hours before surgery. Clear liquids are defined as water, carbonated sodas, black coffee or tea without milk or sugar, and juices without pulp. Many Americans prefer to take their coffee with half and half or coffee creamer rather than black. This study will determine whether the addition of a small amount of cream to coffee makes any difference to the volume in the stomach after 2 hours.
This study will use healthy volunteers as study participants. Each participant will participate in the study 3 times with at least 2 days in between. We will use a bedside ultrasound machine to measure their stomach content volume at baseline and then they will consume one of 3 different prepare drinks - black coffee, coffee with half and half, or coffee with non-dairy coffee creamer. After 2 hours, we will scan their stomach again and measure stomach content volume and compare it to the first measurement. The participants will repeat this two more times on different days so that they would have had a chance to consume all three prepared coffee drinks in a random order.
University of Arkansas is the lead sponsor of 391 studies on the registry; 39 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
12 oz of black coffee with no additives is the first intervention tested
Other: Addition of half and half to coffee · Other: Addition of non-dairy creamer to coffee · Other: Black
12 oz of black coffee with 1 oz of half and half is the first intervention tested
Other: Addition of half and half to coffee · Other: Addition of non-dairy creamer to coffee · Other: Black
12 oz of black coffee with 1 oz of liquid non-dairy creamer is the first intervention tested
Other: Addition of half and half to coffee · Other: Addition of non-dairy creamer to coffee · Other: Black
1 oz of half and half is added to 12 oz of black coffee and given to participants assigned to this arm after the baseline gastric ultrasound
1 oz of non-dairy creamer is added to 12 oz of black coffee and given to participants assigned to this arm after the baseline gastric ultrasound
No Creamer
Difference Between Gastric Volume Post Coffee Consumption Compared to the Baseline Gastric Volume
Gastric volume calculated based on measured cross-sectional area (CSA) of gastric antrum and participant's age. CSA is measured at baseline after fasting for 6 hours and measured again 2 hours after consuming prepared coffee drink
Time frame: Baseline 6 hours after fasting and 2 hours after intervention
| Milestone | 1-Black Coffee, 2-half and Half, 3-creamer | 1-Black Coffee, 2-creamer, 3-half and Half | 1-half and Half, 2-black Coffee, 3-creamer | 1-half and Half, 2-creamer, 3-black Coffee | 1-creamer, 2-black Coffee, 3-half and Half | 1-creamer, 2-half and Half, 3-black Coffee |
|---|---|---|---|---|---|---|
| Started | 2 | 3 | 2 | 4 | 3 | 4 |
| Completed | 2 | 3 | 2 | 4 | 3 | 4 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | 1-Black Coffee, 2-half and Half, 3-creamer | 1-Black Coffee, 2-creamer, 3-half and Half | 1-half and Half, 2-black Coffee, 3-creamer | 1-half and Half, 2-creamer, 3-black Coffee | 1-creamer, 2-black Coffee, 3-half and Half | 1-creamer, 2-half and Half, 3-black Coffee |
|---|---|---|---|---|---|---|
| Started | 2 | 3 | 2 | 4 | 3 | 4 |
| Completed | 2 | 3 | 2 | 4 | 3 | 4 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | 1-Black Coffee, 2-half and Half, 3-creamer | 1-Black Coffee, 2-creamer, 3-half and Half | 1-half and Half, 2-black Coffee, 3-creamer | 1-half and Half, 2-creamer, 3-black Coffee | 1-creamer, 2-black Coffee, 3-half and Half | 1-creamer, 2-half and Half, 3-black Coffee |
|---|---|---|---|---|---|---|
| Started | 2 | 3 | 2 | 4 | 3 | 4 |
| Completed | 2 | 3 | 2 | 4 | 3 | 4 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | 1-Black Coffee, 2-half and Half, 3-creamer | 1-Black Coffee, 2-creamer, 3-half and Half | 1-half and Half, 2-black Coffee, 3-creamer | 1-half and Half, 2-creamer, 3-black Coffee | 1-creamer, 2-black Coffee, 3-half and Half | 1-creamer, 2-half and Half, 3-black Coffee |
|---|---|---|---|---|---|---|
| Started | 2 | 3 | 2 | 4 | 3 | 4 |
| Completed | 2 | 3 | 2 | 4 | 3 | 4 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | 1-Black Coffee, 2-half and Half, 3-creamer | 1-Black Coffee, 2-creamer, 3-half and Half | 1-half and Half, 2-black Coffee, 3-creamer | 1-half and Half, 2-creamer, 3-black Coffee | 1-creamer, 2-black Coffee, 3-half and Half | 1-creamer, 2-half and Half, 3-black Coffee |
|---|---|---|---|---|---|---|
| Started | 2 | 3 | 2 | 4 | 3 | 4 |
| Completed | 2 | 3 | 2 | 4 | 3 | 4 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
Gastric volume calculated based on measured cross-sectional area (CSA) of gastric antrum and participant's age. CSA is measured at baseline after fasting for 6 hours and measured again 2 hours after consuming prepared coffee drink
| milliliters | Black Coffee | Coffee With Half and Half | Coffee With Non-dairy Creamer |
|---|---|---|---|
| Difference Between Gastric Volume Post Coffee Consumption Compared to the Baseline Gastric Volume | 13 (-0.6 to 26.6) | 5 (-8.6 to 18.6) | -1.5 (-15.1 to 12.1) |
Collected over Adverse event data was collected over a 3 month period. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Black Coffee | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Coffee With Half and Half | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Coffee With Non-dairy Creamer | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Age, Categorical(Participants) | All Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 18 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 11 |
| Male | 7 |
| Race and Ethnicity Not Collected(Participants) | All Study Participants |
|---|
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| United States | 18 |
| Body Mass Index(kg/m^2) | All Study Participants |
|---|---|
| Median | 22.4 (20.1 to 34.1) |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Arkansas