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

Completed

• Conditions: Healthy
• Interventions: Radiation: Egg-white sandwich; Radiation: Abbott Vital®

• Registration Number: NCT04812301
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2021-03-17
• Primary Completion: 2021-03-18
• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-23
• Study Completion: 2021-03-25
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Egg-white sandwich	Abbott Vital® is added with 1 mCi Tc-99m sodium phytate, then egg-white sandwich added with 1 mCi Tc-99m sodium phytate
Group 1	Abbott Vital®	Egg-white sandwich is added with 1 mCi Tc-99m sodium phytate, then Abbott Vital® added with 1 mCi Tc-99m sodium phytate
Group 1	Egg-white sandwich	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®	Abbott Vital® is added with 1 mCi Tc-99m sodium phytate, then egg-white sandwich added with 1 mCi Tc-99m sodium phytate

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
Half-emptying time and slope	T1/2	Time required by the stomach to empty 50% of the ingested meal (T1/2; minutes)

Trial Locations

Locations (1)

Hospital Universiti Sains Malaysia; 🇲🇾 Kota Bharu, Malaysia