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Completed

NCT Number: NCT04812301

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

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.

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Key information

Conditions

Healthy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universiti Sains Malaysia

Kota Bharu, 16150, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Egg-white sandwich

Radiation

1 mCi of Tc-99m sodium phytate is added into the egg-white sandwich

Abbott Vital®

Radiation

1 mCi of Tc-99m sodium phytate is added into the Abbott Vital®

Primary outcomes

  1. 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; %)

Secondary outcomes

  1. Half-emptying time and slope

    Time frame: T1/2

    Time required by the stomach to empty 50% of the ingested meal (T1/2; minutes)

  2. 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)

Sponsors and collaborators

Lead sponsor

Universiti Sains Malaysia

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 23, 2021
Registry last updated
Apr 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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