Stomach Processing and Emptying Evaluation With Diet and Ultrasound

NCT06988397 | Not Yet Recruiting

• 1 other identifier: KB/6/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Gastric Emptying; Preoperative Risk Assessment; Healthy Volunteer Study

Keywords

Gastric emptying; Gastric volume; Ultrasound; Gastric POCUS

Outcome Measures

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

  after 15 minutes, 3 hours and 6 hours post-meal

Secondary Outcomes (2)

• Antral cross-sectional area (CSA)

  at 15 minutes, 3 hours, and 6 hours post-meal

• Estimated gastric volume (GV)

  At 15 minutes, 3 hours, and 6 hours post-meal

Study Arms (2)

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.

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.

Interventions

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.

Gastric Ultrasound in Participants Consuming Different Meal Types with Physical Acivity

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02091, Poland

Location

Related Publications (6)

• 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.

  PMID: 24893784 BACKGROUND

• Bolondi 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.

  PMID: 3896910 BACKGROUND

• Perlas 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.

  PMID: 19512861 BACKGROUND

• Sumpelmann 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.

  PMID: 28675504 BACKGROUND

• Pimenta 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.

  PMID: 24336400 BACKGROUND

• Practice 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.

  PMID: 28045707 BACKGROUND

Study Officials

• Mateusz Zawadka

  2nd Department of Anesthesiology and Intensive Care, Medical University of Warsaw, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mateusz Zawadka, MD, PhD

CONTACT

00485992002; oit.csk@uckwum.pl

Aleksandra Barabasz

CONTACT

s082351@student.wum.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: May 23, 2025
• Study Start: June 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)