Clinical trial NCT04812301: Abbott Vital® as an Alternative Meal to the Gold-standard Egg-white Sandwich for Gastric Emptying Scintigraphy (GES)
Official title: Abbott Vital® as an Alternative Meal to the Gold-standard Egg-white Sandwich for Gastric Emptying Scintigraphy (GES) Among Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Gastric emptying
Single-photon emitted-computed tomography
Normative value
Egg-white sandwich
Abbott Vital®
Radiopharmaceuticals
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Reference population is staff and students who are within the campus of Universiti Sains Malaysia and Hospital Universiti Sains Malaysia

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of gastric emptying rates
timeFrame: 4 hours (0 hour, 1/2-hour, 1-hour, 2-hour, 3-hour, 4-hour)
Secondary outcomes:
measure: Half-emptying time and slope
timeFrame: T1/2
measure: Symptoms and satiety/satiation
timeFrame: 4 hours (0 hour, 1/2-hour, 1-hour, 2-hour, 3-hour, 4-hour)
Other outcomes:
Locations:
city: Kota Bharu
country: Malaysia
facility: Hospital Universiti Sains Malaysia
Study officials:
affiliation: Universiti Sains Malaysia
name: Izleen Laili B Ibrahim
role: PRINCIPAL_INVESTIGATOR
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