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.
Full Title of Study: “Abbott Vital® as an Alternative Meal to the Gold-standard Egg-white Sandwich for Gastric Emptying Scintigraphy (GES) Among Healthy Volunteers”
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: March 18, 2021
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.
- Radiation: Egg-white sandwich
- 1 mCi of Tc-99m sodium phytate is added into the egg-white sandwich
- Radiation: Abbott Vital®
- 1 mCi of Tc-99m sodium phytate is added into the Abbott Vital®
Arms, Groups and Cohorts
- Group 1
- Egg-white sandwich is added with 1 mCi Tc-99m sodium phytate, then Abbott Vital® added with 1 mCi Tc-99m sodium phytate
- Group 2
- Abbott Vital® is added with 1 mCi Tc-99m sodium phytate, then egg-white sandwich added with 1 mCi Tc-99m sodium phytate
Clinical Trial Outcome Measures
- Change of gastric emptying rates
- Time Frame: 4 hours (0 hour, 1/2-hour, 1-hour, 2-hour, 3-hour, 4-hour)
- Percentage of gastric meal retention (GMR; %)
- Half-emptying time and slope
- Time Frame: T1/2
- Time required by the stomach to empty 50% of the ingested meal (T1/2; minutes)
- Symptoms and satiety/satiation
- Time Frame: 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)
Participating in This Clinical Trial
- 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
Gender Eligibility: All
15 males and 15 females
Minimum Age: 18 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Universiti Sains Malaysia
- Provider of Information About this Clinical Study
- Principal Investigator: Izleen Laili Binti Ibrahim, Principal Investigator – Universiti Sains Malaysia
- Overall Official(s)
- Izleen Laili B Ibrahim, Principal Investigator, Universiti Sains Malaysia
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