Status:
COMPLETED
Validation of Plant-Based Vegan Meal for Gastric Emptying Testing in 10 Healthy Subjects
Lead Sponsor:
Mayo Clinic
Conditions:
Gastric Emptying
Gastroparesis
Eligibility:
All Genders
18-70 years
Phase:
NA
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 ea...
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 comp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06991036
Start Date
February 3 2025
End Date
April 16 2025
Last Update
May 25 2025
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905