Validation of Plant-Based Vegan Meal for Gastric Emptying Testing in 10 Healthy Subjects

Not Applicable

Completed

• Conditions: Gastric Emptying; Gastroparesis

• Registration Number: NCT06991036
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2025-02-03
• Primary Completion: 2025-04-16
• Study Completion: 2025-04-16
• Status Verified: 2025-05
• Study First Submitted: 2025-05-22
• Study First Submitted QC: 2025-05-22
• Last Update Submitted: 2025-05-22
• Study First Posted: 2025-05-25
• Last Update Posted: 2025-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States