Gastric Emptying, Gastroparesis
Conditions
Brief 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.
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.
Interventions
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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 * No history of stomach cancers * No history of neurodegenerative disorder * Able to sign informed consent and take part in study * BMI \<35
Exclusion criteria
* 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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastric emptying T half | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion emptied using the standard egg diet | 2 hours, 4 hours | The proportion emptied is reported as the percentage of the tracer remaining in the stomach at timepoints of 2 and 4 hours. |
| Proportion emptied using the vegan diet alternative | 2 hours, 4 hours | The proportion emptied is reported as the percentage of the tracer remaining in the stomach at timepoints of 2 and 4 hours. |
Countries
United States
Outcome results
None listed