Stomach Processing and Emptying Evaluation With Diet and Ultrasound
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorMedical University of Warsaw
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Lack of informed consent
Allergy or intolerance to any of the foods used in the study meals
Obesity (BMI > 30 kg/m²)
Diabetes mellitus
Trial design
Design model
Parallel
Treatments tested in this trial
Physical activity after different type of meals
BehavioralStandardized 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Gastric Ultrasound in Participants Consuming Different Meal Types with Physical AcivityExperimental treatment 1 intervention
Group B: Gastric Ultrasound in Participants Consuming Different Meal Types with Subsequent RestNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
after 15 minutes, 3 hours and 6 hours post-mealSecondary outcomes
1
Antral cross-sectional area (CSA)
Changes in CSA (cm²)
Time frame
at 15 minutes, 3 hours, and 6 hours post-meal2
Estimated gastric volume (GV)
Calculated from CSA and age using validated formula
Time frame
At 15 minutes, 3 hours, and 6 hours post-mealSponsors and contacts
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Source ClinicalTrials.gov
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