Healthy
Conditions
Keywords
Gastric emptying, Single-photon emitted-computed tomography, Normative value, Egg-white sandwich, Abbott Vital®, Radiopharmaceuticals
Brief summary
This crossover study is designed to compare the rates of gastric emptying between two diagnostic radioactive meals using the gold-standard egg-white sandwich meal and Abbott Vital®. Healthy participants will be recruited and randomly assigned into either groups of Abbott Vital® and gold-standard egg-white sandwich group. The measurements will be performed over a 4-hour period using a gamma camera, and estimated gastric emptying rates will be calculated using established algorithms.
Detailed description
The gold-standard egg-white sandwich is quite difficult and complicated for staffs to prepare because the food needs to be cooked first and it will take time to prepare. Besides, the egg-white sandwich is not suitable for those with allergies to egg and bread and also to vegetarian patients. This gold-standard meal is also not a common meal for Asian people so some of the people may not tolerate with the meal. The aim of this study is to determine whether Abbott Vital® is as reliable as the gold-standard egg-white sandwich by comparing the gastric meal retention of both meals.
Interventions
RADIATIONEgg-white sandwich
1 mCi of Tc-99m sodium phytate is added into the egg-white sandwich
RADIATIONAbbott Vital®
1 mCi of Tc-99m sodium phytate is added into the Abbott Vital®
Sponsors
Universiti Sains Malaysia
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Normal body mass index (BMI) * Able to give consent * 18 years old above
Exclusion criteria
* Vegetarian * Allergy or cannot tolerate with milk, egg, and bread * Participants with past and current history of chronic medical illness * Currently on medication that can affect gastrointestinal function are also excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of gastric emptying rates | 4 hours (0 hour, 1/2-hour, 1-hour, 2-hour, 3-hour, 4-hour) | Percentage of gastric meal retention (GMR; %) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Half-emptying time and slope | T1/2 | Time required by the stomach to empty 50% of the ingested meal (T1/2; minutes) |
| Symptoms and satiety/satiation | 4 hours (0 hour, 1/2-hour, 1-hour, 2-hour, 3-hour, 4-hour) | Intensity of perceived symptom and satiety/satiation based on Visual Analogue Scale (VAS) |
Countries
Malaysia
Outcome results
None listed