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NCT Number: NCT06988397

Stomach Processing and Emptying Evaluation With Diet and Ultrasound

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02091, Poland

Location contact

Mateusz Zawadka, MD, PhD

CONTACT

[email protected]

00485992002

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

Physical activity after different type of meals

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Antral cross-sectional area (CSA)

    Time frame: at 15 minutes, 3 hours, and 6 hours post-meal

    Changes in CSA (cm²)

  2. Estimated gastric volume (GV)

    Time frame: At 15 minutes, 3 hours, and 6 hours post-meal

    Calculated from CSA and age using validated formula

Study contacts

Contact information is provided by the study sponsor or research team.

Aleksandra Barabasz

CONTACT

[email protected]

Mateusz Zawadka, MD, PhD

CONTACT

[email protected]

00485992002

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

Food Type and Physical Activity Influence on Gastric Emptying Time Assessed by Ultrasound in Healthy Volunteers

Acronym: SPEED-US

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 23, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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