Gastric EmptyingSPEED-USNCT06988397
Stomach Processing and Emptying Evaluation With Diet and Ultrasound
A study testing Physical activity after different type of meals in people with Gastric Emptying and Preoperative Risk Assessment, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Gastric content is a key risk factor for aspiration during anesthesia. Although standard fasting times are recommended, various factors-including GLP-1 receptor agonists,-can delay gastric emptying. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Emptying, Preoperative Risk Assessment, Healthy Volunteer Study
- What is being tested?
- Physical activity after different type of meals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 40 years
- Ability and willingness to provide written informed consent
- Agreement to comply with study procedures, including pre-study dietary restrictions
- No history of gastrointestinal disease
- No recent abdominal surgery
Who cannot join
- Lack of informed consent
- Allergy or intolerance to any of the foods used in the study meals
- Medical conditions known to delay gastric emptying, including:
- Obesity (BMI > 30 kg/m²)
- Diabetes mellitus
- Gastroesophageal reflux disease (GERD)
Show all 14Show fewer
- Hiatal hernia
- Bowel obstruction
- Tube feeding
- Active gastrointestinal disease
- History of gastrointestinal surgery
- Current pregnancy or breastfeeding
- Use of medications affecting gastric motility (e.g., opioids, anticholinergics, GLP-1 receptor agonists)
- Neuromuscular disorders impairing ability to remain in supine position for 6 hours or to walk for 30 minutes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aleksandra Barabasz contact
Poland1 site
Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02091
Mateusz Zawadka, MD, PhD, 00485992002, oit.csk@uckwum.pl
About this study
Official title: Food Type and Physical Activity Influence on Gastric Emptying Time Assessed by Ultrasound in Healthy Volunteers
Gastric content is a key risk factor for aspiration during anesthesia. Although standard fasting times are recommended, various factors-including GLP-1 receptor agonists,-can delay gastric emptying. Gastric ultrasound enables real-time, non-invasive assessment of gastric volume and can help tailor perioperative management. The aim of this study explores the effects of different meal types and physical activity on gastric emptying in healthy individuals.
Read the detailed description
Pulmonary aspiration of gastric contents is a serious and potentially life-threatening complication of anesthesia. Despite adherence to preoperative fasting guidelines issued by the American Society of Anesthesiologists (ASA), certain medical conditions-such as diabetes mellitus-or medications like GLP-1 receptor agonists may significantly delay gastric emptying beyond standard expectations. This creates a need for individualized assessment of gastric contents prior to anesthesia, especially in patients considered at increased risk.
Gastric ultrasound is a non-invasive, point-of-care technique that allows for real-time assessment of gastric volume and content. It may provide a more reliable indicator of aspiration risk than fasting time alone.
This randomized, prospective study aims to evaluate the effects of different types of meals and physical activity levels on gastric emptying time in healthy adult volunteers, using ultrasound-based measurement of the gastric antrum.
Sixty participants aged 18-40 years will be recruited via registration forms provided by the study team. Each participant will provide written informed consent, including acknowledgment of potential food allergens present in the study meals. The day prior to each session, participants will receive a phone call to remind them of dietary restrictions: no clear liquids for 2 hours, no solid foods for 6 hours, and no fatty meals for 8 hours before the study.
Each participant will take part in two separate sessions, conducted on different days. On both days, the participant will arrive fasting and undergo a baseline gastric ultrasound to confirm an empty stomach. If gastric content is detected, the session will be rescheduled.
Participants will be randomly assigned (via computer-generated allocation) to one of three meal groups: high-fat, dairy-based, or fruit/vegetable. Meals will be standardized in volume and composition within each group. The examiner performing the ultrasound will be blinded to the meal group allocation.
In each session, participants will consume the assigned meal within 10 minutes. Gastric ultrasound measurements will be performed at 15 minutes, 3 hours, and 6 hours post-meal. On one of the days, participants will remain in a resting position between measurements. On the other day, participants will walk at a moderate pace for 30 minutes between each measurement interval (i.e., between 0-3 hours and 3-6 hours post-meal). The order of active vs. resting day will be randomized and counterbalanced across participants.
Ultrasound will be performed in the right lateral decubitus position using a convex transducer (2-8 MHz) with an abdominal preset. The antral cross-sectional area (CSA) will be measured using standard landmarks (aorta, SMA, left lobe of liver), and gastric volume will be estimated using a validated formula:
GV = 27.0 + 14.6 × right lateral CSA (cm²) - 1.28 × age (years).
- Being tested
- Physical activity after different type of meals
- Keywords
- Gastric emptying, Gastric volume, Ultrasound, Gastric POCUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity after different type of mealsBehavioural
Standardized physical activity (walking) after consuming one of three meal types (vegetable-based, meat-based, dairy-based). Ultrasound of gastric volume will be performed at 3 and 6 hour between walking sessions.
| Study group | Role | What they receive |
|---|---|---|
| Gastric Ultrasound in Participants Consuming Different Meal Types with Physical Acivity | Experimental | Participants assigned to this arm will undergo an initial gastric ultrasound to confirm fasting status. They will then consume one of three types of meals: vegetable-based, meat-based, or dairy-based. A gastric ultrasound will be performed 15 minutes after meal ingestion. This will be followed by standardized physical activity (walking a predefined distance). Subsequent gastric ultrasound assessments will be performed at 3 hours and 6 hours post-meal, each followed by the same standardized physical activity. The purpose is to evaluate the impact of food type and intermittent physical activity on gastric emptying, as assessed by ultrasound. Receives: Behavioral: Physical activity after different type of meals |
| Gastric Ultrasound in Participants Consuming Different Meal Types with Subsequent Rest | No intervention | Participants in this arm will first undergo a baseline gastric ultrasound to confirm fasting status. They will then consume one of three types of meals: vegetable-based, meat-based, or dairy-based. Gastric ultrasound will be performed 15 minutes after meal ingestion. Unlike the other arm, participants in this group will remain at rest throughout the study period and will not perform any physical activity. Additional gastric ultrasound assessments will be performed at 3 hours and 6 hours post-meal, with participants remaining sedentary between each measurement. This arm will serve to assess the isolated effect of food type on gastric emptying over time without the influence of physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to ultrasonographic signs of an empty stomach
Time (in hours) required to reach a gastric ultrasound profile consistent with an empty stomach (defined individually based on baseline fasting scan), depending on physical activity and meal type
Measured: after 15 minutes, 3 hours and 6 hours post-meal
Secondary outcomes (2)
Antral cross-sectional area (CSA)
Changes in CSA (cm²)
Measured: at 15 minutes, 3 hours, and 6 hours post-meal
Estimated gastric volume (GV)
Calculated from CSA and age using validated formula
Measured: At 15 minutes, 3 hours, and 6 hours post-meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gastric EmptyingStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mateusz Zawadka, Principal investigator, 2nd Department of Anesthesiology and Intensive Care, Medical University of Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988397
- Sponsor's protocol ID
- KB/6/2025
- Acronym
- SPEED-US
- Status last verified
- May 2025
- First submitted
- 17 Apr 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Van de Putte P, Perlas A. Ultrasound assessment of gastric content and volume. Br J Anaesth. 2014 Jul;113(1):12-22. doi: 10.1093/bja/aeu151. Epub 2014 Jun 3.
PubMed 24893784Bolondi L, Bortolotti M, Santi V, Calletti T, Gaiani S, Labo G. Measurement of gastric emptying time by real-time ultrasonography. Gastroenterology. 1985 Oct;89(4):752-9. doi: 10.1016/0016-5085(85)90569-4.
PubMed 3896910Perlas A, Chan VW, Lupu CM, Mitsakakis N, Hanbidge A. Ultrasound assessment of gastric content and volume. Anesthesiology. 2009 Jul;111(1):82-9. doi: 10.1097/ALN.0b013e3181a97250.
PubMed 19512861Sumpelmann AE, Sumpelmann R, Lorenz M, Eberwien I, Dennhardt N, Boethig D, Russo SG. Ultrasound assessment of gastric emptying after breakfast in healthy preschool children. Paediatr Anaesth. 2017 Aug;27(8):816-820. doi: 10.1111/pan.13172. Epub 2017 Jul 4.
PubMed 28675504Pimenta GP, de Aguilar-Nascimento JE. Prolonged preoperative fasting in elective surgical patients: why should we reduce it? Nutr Clin Pract. 2014 Feb;29(1):22-8. doi: 10.1177/0884533613514277. Epub 2013 Dec 11.
PubMed 24336400Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.
PubMed 28045707
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Type and Physical Activity Influence on Gastric Emptying Time Assessed by Ultrasound in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06988397
- Acronym / sponsor ID
- SPEED-US / KB/6/2025
- Keywords
- Gastric emptying, Gastric volume, Ultrasound, Gastric POCUS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gastric content is a key risk factor for aspiration during anesthesia. Although standard fasting times are recommended, various factors-including GLP-1 receptor agonists,-can delay gastric emptying. Gastric ultrasound enables real-time, non-invasive assessment of gastric volume and can help tailor perioperative management. The aim of this study explores the effects of different meal types and physical activity on gastric emptying in healthy individuals.
Detailed description
Pulmonary aspiration of gastric contents is a serious and potentially life-threatening complication of anesthesia. Despite adherence to preoperative fasting guidelines issued by the American Society of Anesthesiologists (ASA), certain medical conditions-such as diabetes mellitus-or medications like GLP-1 receptor agonists may significantly delay gastric emptying beyond standard expectations. This creates a need for individualized assessment of gastric contents prior to anesthesia, especially in patients considered at increased risk.
Gastric ultrasound is a non-invasive, point-of-care technique that allows for real-time assessment of gastric volume and content. It may provide a more reliable indicator of aspiration risk than fasting time alone.
This randomized, prospective study aims to evaluate the effects of different types of meals and physical activity levels on gastric emptying time in healthy adult volunteers, using ultrasound-based measurement of the gastric antrum.
Sixty participants aged 18-40 years will be recruited via registration forms provided by the study team. Each participant will provide written informed consent, including acknowledgment of potential food allergens present in the study meals. The day prior to each session, participants will receive a phone call to remind them of dietary restrictions: no clear liquids for 2 hours, no solid foods for 6 hours, and no fatty meals for 8 hours before the study.
Each participant will take part in two separate sessions, conducted on different days. On both days, the participant will arrive fasting and undergo a baseline gastric ultrasound to confirm an empty stomach. If gastric content is detected, the session will be rescheduled.
Participants will be randomly assigned (via computer-generated allocation) to one of three meal groups: high-fat, dairy-based, or fruit/vegetable. Meals will be standardized in volume and composition within each group. The examiner performing the ultrasound will be blinded to the meal group allocation.
In each session, participants will consume the assigned meal within 10 minutes. Gastric ultrasound measurements will be performed at 15 minutes, 3 hours, and 6 hours post-meal. On one of the days, participants will remain in a resting position between measurements. On the other day, participants will walk at a moderate pace for 30 minutes between each measurement interval (i.e., between 0-3 hours and 3-6 hours post-meal). The order of active vs. resting day will be randomized and counterbalanced across participants.
Ultrasound will be performed in the right lateral decubitus position using a convex transducer (2-8 MHz) with an abdominal preset. The antral cross-sectional area (CSA) will be measured using standard landmarks (aorta, SMA, left lobe of liver), and gastric volume will be estimated using a validated formula:
GV = 27.0 + 14.6 × right lateral CSA (cm²) - 1.28 × age (years).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric Ultrasound in Participants Consuming Different Meal Types with Physical Acivity | Experimental | Behavioral: Physical activity after different type of mealsParticipants assigned to this arm will undergo an initial gastric ultrasound to confirm fasting status. They will then consume one of three types of meals: vegetable-based, meat-based, or dairy-based. A gastric ultrasound will be performed 15 minutes after meal ingestion. This will be followed by standardized physical activity (walking a predefined distance). Subsequent gastric ultrasound assessments will be performed at 3 hours and 6 hours post-meal, each followed by the same standardized physical activity. The purpose is to evaluate the impact of food type and intermittent physical activity on gastric emptying, as assessed by ultrasound. |
| Gastric Ultrasound in Participants Consuming Different Meal Types with Subsequent Rest | No intervention | –Participants in this arm will first undergo a baseline gastric ultrasound to confirm fasting status. They will then consume one of three types of meals: vegetable-based, meat-based, or dairy-based. Gastric ultrasound will be performed 15 minutes after meal ingestion. Unlike the other arm, participants in this group will remain at rest throughout the study period and will not perform any physical activity. Additional gastric ultrasound assessments will be performed at 3 hours and 6 hours post-meal, with participants remaining sedentary between each measurement. This arm will serve to assess the isolated effect of food type on gastric emptying over time without the influence of physical activity. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 and 40 years
- Ability and willingness to provide written informed consent
- Agreement to comply with study procedures, including pre-study dietary restrictions
- No history of gastrointestinal disease
- No recent abdominal surgery
Key exclusion criteria (14 listed)
- Lack of informed consent
- Allergy or intolerance to any of the foods used in the study meals
- Medical conditions known to delay gastric emptying, including:
- Obesity (BMI > 30 kg/m²)
- Diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity after different type of mealsStandardized physical activity (walking) after consuming one of three meal types (vegetable-based, meat-based, dairy-based). Ultrasound of gastric volume will be performed at 3 and 6 hour between walking sessions. | Behavioural | Gastric Ultrasound in Participants Consuming Different Meal Types with Physical Acivity |
Primary outcome
Time to ultrasonographic signs of an empty stomach
Time frame: after 15 minutes, 3 hours and 6 hours post-meal
Time (in hours) required to reach a gastric ultrasound profile consistent with an empty stomach (defined individually based on baseline fasting scan), depending on physical activity and meal type
2 secondary outcomes
Antral cross-sectional area (CSA)
Time frame: at 15 minutes, 3 hours, and 6 hours post-meal
Estimated gastric volume (GV)
Time frame: At 15 minutes, 3 hours, and 6 hours post-meal
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Background: PubMed 24893784Van de Putte P, Perlas A. Ultrasound assessment of gastric content and volume. Br J Anaesth. 2014 Jul;113(1):12-22. doi: 10.1093/bja/aeu151. Epub 2014 Jun 3.
- Background: PubMed 3896910Bolondi L, Bortolotti M, Santi V, Calletti T, Gaiani S, Labo G. Measurement of gastric emptying time by real-time ultrasonography. Gastroenterology. 1985 Oct;89(4):752-9. doi: 10.1016/0016-5085(85)90569-4.
- Background: PubMed 19512861Perlas A, Chan VW, Lupu CM, Mitsakakis N, Hanbidge A. Ultrasound assessment of gastric content and volume. Anesthesiology. 2009 Jul;111(1):82-9. doi: 10.1097/ALN.0b013e3181a97250.
- Background: PubMed 28675504Sumpelmann AE, Sumpelmann R, Lorenz M, Eberwien I, Dennhardt N, Boethig D, Russo SG. Ultrasound assessment of gastric emptying after breakfast in healthy preschool children. Paediatr Anaesth. 2017 Aug;27(8):816-820. doi: 10.1111/pan.13172. Epub 2017 Jul 4.
- Background: PubMed 24336400Pimenta GP, de Aguilar-Nascimento JE. Prolonged preoperative fasting in elective surgical patients: why should we reduce it? Nutr Clin Pract. 2014 Feb;29(1):22-8. doi: 10.1177/0884533613514277. Epub 2013 Dec 11.
- Background: PubMed 28045707Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aleksandra Barabasz contact
Mateusz Zawadka principal investigator
2nd Department of Anesthesiology and Intensive Care, Medical University of Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity after different type of meals in people with Gastric Emptying and Preoperative Risk Assessment, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mateusz Zawadka, MD, PhD (00485992002, oit.csk@uckwum.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to ultrasonographic signs of an empty stomach (time frame: after 15 minutes, 3 hours and 6 hours post-meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06988397, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.