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

April 6, 2021 updated by: Izleen Laili Binti Ibrahim, Universiti Sains Malaysia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Kota Bharu, Malaysia, 16150
        • Hospital Universiti Sains Malaysia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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®
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
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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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; %)
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 Frame: T1/2
Time required by the stomach to empty 50% of the ingested meal (T1/2; minutes)
T1/2
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)
4 hours (0 hour, 1/2-hour, 1-hour, 2-hour, 3-hour, 4-hour)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Sains Malaysia

Investigators

  • Principal Investigator: Izleen Laili B Ibrahim, Universiti Sains Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2021

Primary Completion (Actual)

March 18, 2021

Study Completion (Actual)

March 25, 2021

Study Registration Dates

First Submitted

March 18, 2021

First Submitted That Met QC Criteria

March 22, 2021

First Posted (Actual)

March 23, 2021

Study Record Updates

Last Update Posted (Actual)

April 9, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • USM/JEPeM/20120684

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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