Validation of Plant-Based Vegan Meal for Gastric Emptying
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 24-008112
About this study
The purpose of this study is to compare the gastric emptying T half during assessment using the standard egg diet compared to the vegan diet alternative measured approximately 1 week apart.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age 18-70 years old
- Healthy (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:
- Under the age of 18, over the age of 70
- History of diabetes
- Taking medications that affect gastric emptying (eg GLP-1 agonists, opioids, calcium channel blockers, pramlintide, tricyclic antidepressants, busirone)
- Active gastrointestinal symptoms or disease
- Prior gastrointestinal surgey 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 full study protocol which could interfere with the study assessments
- Allergy to eggs, allergy to soy, allergy to oats, or other study products
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 07/26/2024. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available