Gastric EmptyingNCT06991036
Validation of Plant-Based Vegan Meal for Gastric Emptying Testing in 10 Healthy Subjects
A study testing Gastric emptying test in people with Gastric Emptying and Gastroparesis, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research study is to compare the stomach emptying function using a current standard meal which includes eggs and our new vegan meal alternatives for patients who are not able to eat eggs. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Emptying, Gastroparesis
- What is being tested?
- Gastric emptying test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2025to 16 Apr 2025
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No history of diabetes
- Not on medications that affect gastric emptying without diagnosis of active gastrointestinal disease
- No history of prior gastrointestinal surgery that would interfere with testing
- No recent (within last 10 years) gastritis, gastrointestinal infections, COVID-19 (within last 2 years), H pylori, peptic ulcer disease
- Not pregnant,
- Not actively breast-feeding
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- No history of stomach cancers
- No history of neurodegenerative disorder
- Able to sign informed consent and take part in study
- BMI <35
Who cannot join
- History of diabetes
- Taking medications that affect gastric emptying (e.g., GLP-1 agonists, opioids, calcium channel blockers, pramlintide, tricyclic antidepressants, buspirone)
- Active gastrointestinal symptoms or disease
- Prior gastrointestinal surgery that could interfere with conduct or interpretation of the studies (gastric bypass, gastric sleeves, esophagectomy, vagal nerve stimulators, etc)
- Pregnancy or breast-feeding
- History of neurodegenerative disorders (Parkinson's disease, multiple sclerosis, dementia, documented autonomic dysfunction, amyotrophic lateral sclerosis, etc)
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- Vulnerable population (dementia, severe intellectual disability etc)
- Any condition or personal circumstance that, in the opinion of the investigator, renders the subject unlikely or unable to comply with the full study protocol which could interfere with the study assessments
- Allergy to eggs, allergy to soy, allergy to oats, or other study products
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to compare the stomach emptying function using a current standard meal which includes eggs and our new vegan meal alternatives for patients who are not able to eat eggs.
Read the detailed description
10 healthy participants underwent randomized crossover (with concealed allocation) GE scintigraphy with standard and vegan meals, spaced ≥3 days apart to measure GE% at 2h, 4h, and GE T1/2. Group comparisons and variance analysis included Rank Sum tests and Bland-Altman plots.
- Conditions
- Gastric Emptying, Gastroparesis
- Being tested
- Gastric emptying test
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric emptying testOther
After the radiolabeled breakfast meal is ingested, the participant is positioned upright between the two detectors of the Brightview system (Phillips Medical Systems, Cleveland, OH). Detector height is adjusted to include esophageal uptake, the stomach, and the small bowel. Anterior and posterior static images are acquired at 2 minutes per image using a 256 x 256 word mode matrix. Anterior and posterior images are again acquired at 1 and 2 hours post-ingestion of the radiolabeled breakfast meal.
The participant is then given the designated 'push' meal after completion of the 2-hour images. At 4 hours post-ingestion, images are acquired in the same manner as at previous time points.
| Study group | Role | What they receive |
|---|---|---|
| Standard egg meal then vegan meal | Experimental | At first visit, gastric emptying test will be performed on subjects after consuming the standard egg meal consisting of two large whole, scrambled chicken eggs, one slice of wheat bread, and one glass (around 236 mL) of skim milk and provided approximately 320 kcal and 30% fat.
Approximately 1 week later, the gastric emptying test will be performed again after subjects consume the vegan breakfast meal consisting of around 4 fl oz of JUST Egg® (a plant-based egg substitute) which is primarily made from mung beans, two slices of gluten-free multigrain bread, 4 fl oz of orange juice, and ½ a cup of water. Receives: Other: Gastric emptying test |
| Vegan meal then standard egg meal | Experimental | At first visit, gastric emptying test will be performed on subjects after consuming the vegan breakfast meal consisting of around 4 fl oz of JUST Egg® (a plant-based egg substitute) which is primarily made from mung beans, two slices of gluten-free multigrain bread, 4 fl oz of orange juice, and ½ a cup of water.
Approximately 1 week later, the gastric emptying test will be performed again after subjects consume the standard egg meal consisting of two large whole, scrambled chicken eggs, one slice of wheat bread, and one glass (around 236 mL) of skim milk and provided approximately 320 kcal and 30% fat. Receives: Other: Gastric emptying test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying T half
Gastric emptying T half is measured using gastric emptying scintigraphy, which involves taking a meal with radioactive tracer and measuring the time it takes for 50% of the meal to leave the stomach. Results are reported in minutes.
Measured: Baseline, 1 week
Secondary outcomes (2)
Proportion emptied using the standard egg diet
The proportion emptied is reported as the percentage of the tracer remaining in the stomach at timepoints of 2 and 4 hours.
Measured: 2 hours, 4 hours
Proportion emptied using the vegan diet alternative
The proportion emptied is reported as the percentage of the tracer remaining in the stomach at timepoints of 2 and 4 hours.
Measured: 2 hours, 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start3 Feb 2025
- Primary completion16 Apr 2025
- Study completion16 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric EmptyingStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Camilleri, MD, Mayo Clinic
- Investigators
- Michael Camilleri, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991036
- Sponsor's protocol ID
- 24-008112
- Status last verified
- May 2025
- First submitted
- 22 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jencks KJ, Abdelnaem N, Carlson P, Busciglio I, Burton D, Ryks M, Johnson DR, Navin P, Bach C, Paulsen AM, Bartlett DJ, Camilleri M. A Pilot Validation Study of Plant-Based and Allergy-Friendly Alternative for Testing Gastric Emptying: A Randomized Trial in Healthy Participants. Neurogastroenterol Motil. 2026 Feb;38(2):e70268. doi: 10.1111/nmo.70268.
PubMed 41681033
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Plant-Based Vegan Meal for Gastric Emptying Testing in 10 Healthy Subjects
- ClinicalTrials.gov ID
- NCT06991036
- Acronym / sponsor ID
- 24-008112
- Conditions
- Gastric Emptying, Gastroparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 16 Apr 2025 (actual)
- Study completion
- 16 Apr 2025 (actual)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to compare the stomach emptying function using a current standard meal which includes eggs and our new vegan meal alternatives for patients who are not able to eat eggs.
Detailed description
10 healthy participants underwent randomized crossover (with concealed allocation) GE scintigraphy with standard and vegan meals, spaced ≥3 days apart to measure GE% at 2h, 4h, and GE T1/2. Group comparisons and variance analysis included Rank Sum tests and Bland-Altman plots.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard egg meal then vegan meal | Experimental | Other: Gastric emptying testAt first visit, gastric emptying test will be performed on subjects after consuming the standard egg meal consisting of two large whole, scrambled chicken eggs, one slice of wheat bread, and one glass (around 236 mL) of skim milk and provided approximately 320 kcal and 30% fat. Approximately 1 week later, the gastric emptying test will be performed again after subjects consume the vegan breakfast meal consisting of around 4 fl oz of JUST Egg® (a plant-based egg substitute) which is primarily made from mung beans, two slices of gluten-free multigrain bread, 4 fl oz of orange juice, and ½ a cup of water. |
| Vegan meal then standard egg meal | Experimental | Other: Gastric emptying testAt first visit, gastric emptying test will be performed on subjects after consuming the vegan breakfast meal consisting of around 4 fl oz of JUST Egg® (a plant-based egg substitute) which is primarily made from mung beans, two slices of gluten-free multigrain bread, 4 fl oz of orange juice, and ½ a cup of water. Approximately 1 week later, the gastric emptying test will be performed again after subjects consume the standard egg meal consisting of two large whole, scrambled chicken eggs, one slice of wheat bread, and one glass (around 236 mL) of skim milk and provided approximately 320 kcal and 30% fat. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- No history of diabetes
- Not on medications that affect gastric emptying without diagnosis of active gastrointestinal disease
- No history of prior gastrointestinal surgery that would interfere with testing
- No recent (within last 10 years) gastritis, gastrointestinal infections, COVID-19 (within last 2 years), H pylori, peptic ulcer disease
- Not pregnant,
Key exclusion criteria (9 listed)
- History of diabetes
- Taking medications that affect gastric emptying (e.g., GLP-1 agonists, opioids, calcium channel blockers, pramlintide, tricyclic antidepressants, buspirone)
- Active gastrointestinal symptoms or disease
- Prior gastrointestinal surgery that could interfere with conduct or interpretation of the studies (gastric bypass, gastric sleeves, esophagectomy, vagal nerve stimulators, etc)
- Pregnancy or breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric emptying testAfter the radiolabeled breakfast meal is ingested, the participant is positioned upright between the two detectors of the Brightview system (Phillips Medical Systems, Cleveland, OH). Detector height is adjusted to include esophageal uptake, the stomach, and the small bowel. Anterior and posterior static images are acquired at 2 minutes per image using a 256 x 256 word mode matrix. Anterior and posterior images are again acquired at 1 and 2 hours post-ingestion of the radiolabeled breakfast meal. The participant is then given the designated 'push' meal after completion of the 2-hour images. At 4 hours post-ingestion, images are acquired in the same manner as at previous time points. | Other | Standard egg meal then vegan meal, Vegan meal then standard egg meal |
Primary outcome
Gastric emptying T half
Time frame: Baseline, 1 week
Gastric emptying T half is measured using gastric emptying scintigraphy, which involves taking a meal with radioactive tracer and measuring the time it takes for 50% of the meal to leave the stomach. Results are reported in minutes.
2 secondary outcomes
Proportion emptied using the standard egg diet
Time frame: 2 hours, 4 hours
Proportion emptied using the vegan diet alternative
Time frame: 2 hours, 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Derived from this study: PubMed 41681033Jencks KJ, Abdelnaem N, Carlson P, Busciglio I, Burton D, Ryks M, Johnson DR, Navin P, Bach C, Paulsen AM, Bartlett DJ, Camilleri M. A Pilot Validation Study of Plant-Based and Allergy-Friendly Alternative for Testing Gastric Emptying: A Randomized Trial in Healthy Participants. Neurogastroenterol Motil. 2026 Feb;38(2):e70268. doi: 10.1111/nmo.70268.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Camilleri, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric emptying test in people with Gastric Emptying and Gastroparesis, run by Mayo Clinic at 1 site in United States.
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 10 inclusion and 9 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 25 May 2025. 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 United States. 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?
Gastric emptying T half (time frame: Baseline, 1 week). 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 NCT06991036, which also lists 1 linked publication.
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 25 May 2025.