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HealthyNCT04812301

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

An observational study of Healthy, run by Universiti Sains Malaysia at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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®. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Egg-white sandwich and Abbott Vital®
Type of treatment
Surgery or procedure
How many people
30 participants
Where
1 siteMalaysia
Study dates
17 Mar 2021to 25 Mar 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Reference population is staff and students who are within the campus of Universiti Sains Malaysia and Hospital Universiti Sains Malaysia

Who may be able to join

  • Normal body mass index (BMI)
  • Able to give consent
  • 18 years old above

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • Hospital Universiti Sains Malaysia

    Kota Bharu, 16150

Other trials in Malaysia

About this study

Official title: 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.

Read the 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.

Conditions
Healthy
Being tested
Egg-white sandwich, Abbott Vital®
Keywords
Gastric emptying, Single-photon emitted-computed tomography, Normative value, Egg-white sandwich, Abbott Vital®, Radiopharmaceuticals

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Egg-white sandwichRadiation

    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®

Study groups in NCT04812301
Study groupRoleWhat they receive
Group 1Egg-white sandwich is added with 1 mCi Tc-99m sodium phytate, then Abbott Vital® added with 1 mCi Tc-99m sodium phytate
Receives: Radiation: Egg-white sandwich; Radiation: Abbott Vital®
Group 2Abbott Vital® is added with 1 mCi Tc-99m sodium phytate, then egg-white sandwich added with 1 mCi Tc-99m sodium phytate
Receives: Radiation: Egg-white sandwich; Radiation: Abbott Vital®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of gastric emptying rates

    Percentage of gastric meal retention (GMR; %)

    Measured: 4 hours (0 hour, 1/2-hour, 1-hour, 2-hour, 3-hour, 4-hour)

Secondary outcomes (2)

  1. Half-emptying time and slope

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

    Measured: T1/2

  2. Symptoms and satiety/satiation

    Intensity of perceived symptom and satiety/satiation based on Visual Analogue Scale (VAS)

    Measured: 4 hours (0 hour, 1/2-hour, 1-hour, 2-hour, 3-hour, 4-hour)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2021
  2. Study start17 Mar 2021
  3. Primary completion18 Mar 2021
  4. Study completion25 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04812301
Sponsor's protocol ID
USM/JEPeM/20120684
Status last verified
Apr 2021
First submitted
18 Mar 2021
Last updated
9 Apr 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Abell TL, Camilleri M, Donohoe K, Hasler WL, Lin HC, Maurer AH, McCallum RW, Nowak T, Nusynowitz ML, Parkman HP, Shreve P, Szarka LA, Snape WJ Jr, Ziessman HA; American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine. Consensus recommendations for gastric emptying scintigraphy: a joint report of the American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine. J Nucl Med Technol. 2008 Mar;36(1):44-54. doi: 10.2967/jnmt.107.048116. Epub 2008 Feb 20.

    PubMed 18287197

  • Banks KP, Syed K, Parekh M, McWhorter N. Gastric Emptying Scan. 2023 Sep 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK531503/

    PubMed 30285398

  • Cook AC, Anderson RH. Attitudinally correct nomenclature. Heart. 2002 Jun;87(6):503-6. doi: 10.1136/heart.87.6.503. No abstract available.

    PubMed 12010926

  • Co. (2017). CIS bio international, member of IBA Molecular group of companies PHYTACIS Kit for the preparation of technetium [ 99m Tc] phytate injection USER PACKAGE LEAFLET.

  • Donohoe KJ, Maurer AH, Ziessman HA, Urbain JL, Royal HD, Martin-Comin J; Society for Nuclear Medicine; American Neurogastroenterology and Motility Society. Procedure guideline for adult solid-meal gastric-emptying study 3.0. J Nucl Med Technol. 2009 Sep;37(3):196-200. doi: 10.2967/jnmt.109.067843. Epub 2009 Aug 19. No abstract available.

    PubMed 19692450

  • Farrell, M. B. (2017). Gastric Emptying Scintigraphy* GASTRIC EMPTYING SCINTIGRAPHY • Farrell. Abdominal Imaging, 2017. https://doi.org/10.2967/jnmt.117.227892

  • Farrell MB. Gastric Emptying Scintigraphy. J Nucl Med Technol. 2019 Jun;47(2):111-119. doi: 10.2967/jnmt.117.227892. No abstract available.

    PubMed 31167827

  • Fisher DR, Fahey FH. Appropriate Use of Effective Dose in Radiation Protection and Risk Assessment. Health Phys. 2017 Aug;113(2):102-109. doi: 10.1097/HP.0000000000000674.

    PubMed 28658055

  • Frederic H. Fahey. (2018). 1 Basic Principles of SPECT and SPECT/CT and Quality Control. In SPECT and SPECT/CT. Georg Thieme Verlag. https://doi.org/10.1055/b-0038-149733

  • Halland M, Bharucha AE. Relationship Between Control of Glycemia and Gastric Emptying Disturbances in Diabetes Mellitus. Clin Gastroenterol Hepatol. 2016 Jul;14(7):929-36. doi: 10.1016/j.cgh.2015.11.021. Epub 2015 Dec 21.

    PubMed 26717862

  • ICRP. (1992a). Radiological Protection in Biomedical Research. Annals of ICRP, Pergamon Press. 62.

  • ICRP. (1992b). Radiological Protection in Biomedical Research. ICRP Publication 62. Ann. ICRP 22 (3). https://doi.org/10.1177/ANIB_22_3

  • Knight LC. Update on gastrointestinal radiopharmaceuticals and dosimetry estimates. Semin Nucl Med. 2012 Mar;42(2):138-44. doi: 10.1053/j.semnuclmed.2011.11.001.

    PubMed 22293168

  • Kusano M, Zai H, Shimoyama Y, Hosaka H, Kuribayashi S, Kawamura O, Mori M. Rapid gastric emptying, rather than delayed gastric emptying, might provoke functional dyspepsia. J Gastroenterol Hepatol. 2011 Apr;26 Suppl 3:75-8. doi: 10.1111/j.1440-1746.2011.06627.x.

    PubMed 21443715

  • Leiper JB. Fate of ingested fluids: factors affecting gastric emptying and intestinal absorption of beverages in humans. Nutr Rev. 2015 Sep;73 Suppl 2:57-72. doi: 10.1093/nutrit/nuv032.

    PubMed 26290292

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by Universiti Sains Malaysia at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of gastric emptying rates (time frame: 4 hours (0 hour, 1/2-hour, 1-hour, 2-hour, 3-hour, 4-hour)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04812301, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.

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