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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Black coffee first | Placebo Comparator | 12 oz of black coffee with no additives is the first intervention tested |
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| Coffee with half and half first | Active Comparator | 12 oz of black coffee with 1 oz of half and half is the first intervention tested |
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| Coffee with non-dairy creamer first | Active Comparator | 12 oz of black coffee with 1 oz of liquid non-dairy creamer is the first intervention tested |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Addition of half and half to coffee | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline 6 hours after fasting and 2 hours after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Yeh, MBBS | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72211 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1-Black Coffee, 2-half and Half, 3-creamer | 12 oz of black coffee with no additives is given to participants assigned to this arm first after the baseline gastric ultrasound. Based on the randomization order, participants will then participate in the coffee with half and half arm and then the coffee with non-dairy creamer arm. |
| FG001 | 1-Black Coffee, 2-creamer, 3-half and Half | 12 oz of black coffee with no additives is given to participants assigned to this arm first after the baseline gastric ultrasound. Based on the randomization order, participants will then participate in the coffee with non-dairy creamer arm then coffee with half and half. |
| FG002 | 1-half and Half, 2-black Coffee, 3-creamer | 12 oz of black coffee with 1 oz of half and half is given to participants assigned to this arm first after the baseline gastric ultrasound. Based on the randomization order, participants will then participate in the black coffee arm and the coffee with non-dairy creamer arm. |
| FG003 | 1-half and Half, 2-creamer, 3-black Coffee | 12 oz of black coffee with 1 oz of half and half is given to participants assigned to this arm first after the baseline gastric ultrasound. Based on the randomization order, participants will then participate in the coffee with non-dairy creamer arm then the black coffee arm. |
| FG004 | 1-creamer, 2-black Coffee, 3-half and Half | 12 oz of black coffee with 1 oz of liquid non-dairy creamer is given to participants assigned to this arm first after the baseline gastric ultrasound. Based on the randomization order, participants will then participate in the black coffee arm then the coffee with half and half arm. |
| FG005 | 1-creamer, 2-half and Half, 3-black Coffee | 12 oz of black coffee with 1 oz of liquid non-dairy creamer is given to participants assigned to this arm first after the baseline gastric ultrasound. Based on the randomization order, participants will then participate in the coffee with half and half arm then the black coffee arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (2 Hours) |
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| Washout Period (2 Days) |
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| Second Intervention (2 Hours) |
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| Washout Period (2 Days) |
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| Third Intervention (2 Hours) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All study participants were randomized to receive all 3 interventions of consumption of black coffee, coffee with half and half, and coffee with non-dairy creamer. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | 95% Confidence Interval | milliliters | Baseline 6 hours after fasting and 2 hours after intervention |
|
Adverse event data was collected over a 3 month period
This study was low risk for serious adverse events and all-cause mortality. The collection approach for adverse events was through non-systematic assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Black Coffee | 12 oz of black coffee with no additives given to participants after the baseline gastric ultrasound either as the first, second, or third intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Yeh | University of Arkansas for Medical Sciences | (501) 686-6114 | jyeh@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 29, 2020 | Mar 6, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005215 | Fasting |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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Randomized Controlled Crossover
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The investigators performing the gastric ultrasound will be blinded to which arm of the study the participant is currently in.
| Addition of non-dairy creamer to coffee | Other | 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 |
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| Black | Other | No Creamer |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Median | Full Range | kg/m^2 |
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| OG002 | Coffee With Non-dairy Creamer | 12 oz of black coffee with 1 oz of liquid non-dairy creamer given to participants after the baseline gastric ultrasound either as the first, second, or third intervention. |
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Coffee With Half and Half | 12 oz of black coffee with 1 oz of half and half given to participants after the baseline gastric ultrasound either as the first, second, or third intervention. | 0 | 18 | 0 | 18 | 0 | 18 |
| EG002 | Coffee With Non-dairy Creamer | 12 oz of black coffee with 1 oz of liquid non-dairy creamer given to participants after the baseline gastric ultrasound either as the first, second, or third intervention. | 0 | 18 | 0 | 18 | 0 | 18 |
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