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Effect of Fasting Recommendations Among Patients Using GLP-1 Receptor Agonists

NCT06839248 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2026-05-11

No results posted yet for this study

Summary

The aim of this randomised controlled trial is to determine the effect of a 24-hour clear liquid diet compared to standard fasting guidelines on the proportion of participants who present with increased residual gastric contents during their study visit. It also aims to determine the effect of a 24-hour clear liquid diet compared to standard fasting guidelines on:

* Solid content or thick fluids
* Patient-reported outcome measures (PROMs), including thirst, hunger, nausea, fatigue, and anxiety.
* Compliance measures, including adherence with the intervention, time since last oral intake of solid foods, and time since last oral intake of clear liquids.

We will enrol adults who are currently using any once-weekly glucagon-like peptide-1 receptor agonist (GLP-1RA) medication. Participants will be allocated in a 1:1 ratio to follow a 24-hour clear liquid diet or standard fasting guidelines prior to attending a study visit where participants will undergo a blinded gastric ultrasound assessment.

Conditions

  • Residual Gastric Contents
  • Pulmonary Aspiration of Gastric Contents

Interventions

OTHER

24-hour clear liquid diet

Participants randomly assigned to this arm will be instructed to follow a 24-hour clear liquid diet, defined as NPO for solids and last intake of clear liquids no less than 2 hours prior to the trial visit.

OTHER

Standard fasting guidelines

Participants randomly assigned to this arm will be instructed to follow the ASA and ANZCA standards for preoperative fasting prior to presenting for their trial visit. This requires participants to only consume clear liquids up to 2 hours, a light or low calorific meal up to 6 hours, and fasting from fried foods, fatty foods, or meat for at least 8 hours prior to the trial visit.

Sponsors & Collaborators

  • St Vincent's Hospital Melbourne

    lead OTHER

Principal Investigators

  • Prof Michelle Dowsey, BHealthSci(Nursing), MEpi, PhD · St Vincent's Hospital Melbourne

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-20
Primary Completion
2027-02-01
Completion
2027-02-01

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06839248 on ClinicalTrials.gov