Abbott Vital® as an Alternative Meal to the Gold-standard Egg-white Sandwich for Gastric Emptying Scintigraphy (GES)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Abbott Vital® as an Alternative Meal to the Gold-standard Egg-white Sandwich for Gastric Emptying Scintigraphy (GES) Among Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Radiation: Egg-white sandwich
* Radiation: Abbott Vital®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Egg-white sandwich is added with 1 mCi Tc-99m sodium phytate, then Abbott Vital® added with 1 mCi Tc-99m sodium phytate | Radiation: Egg-white sandwich<br>* 1 mCi of Tc-99m sodium phytate is added into the egg-white sandwich<br>Radiation: Abbott Vital®<br>* 1 mCi of Tc-99m sodium phytate is added into the Abbott Vital®<br>|
| Group 2<br>Abbott Vital® is added with 1 mCi Tc-99m sodium phytate, then egg-white sandwich added with 1 mCi Tc-99m sodium phytate | Radiation: Egg-white sandwich<br>* 1 mCi of Tc-99m sodium phytate is added into the egg-white sandwich<br>Radiation: Abbott Vital®<br>* 1 mCi of Tc-99m sodium phytate is added into the Abbott Vital®<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of gastric emptying rates | Percentage of gastric meal retention (GMR; %) | 4 hours (0 hour, 1/2-hour, 1-hour, 2-hour, 3-hour, 4-hour) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Half-emptying time and slope | Time required by the stomach to empty 50% of the ingested meal (T1/2; minutes) | T1/2 | 
| Symptoms and satiety/satiation | Intensity of perceived symptom and satiety/satiation based on Visual Analogue Scale (VAS) | 4 hours (0 hour, 1/2-hour, 1-hour, 2-hour, 3-hour, 4-hour) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric emptying, Single-photon emitted-computed tomography, Normative value, Egg-white sandwich, Abbott Vital®, Radiopharmaceuticals