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

Mayo Clinic

Status: Completed

Conditions: Gastric Emptying; Gastroparesis

Treatments: Other: Gastric emptying test

Study type: Interventional

Funder types: Other

Identifiers

NCT06991036

24-008112

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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10 participants in 2 patient groups

Standard egg meal then vegan meal

Experimental group

Description:

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.

Treatment:

Other: Gastric emptying test

Vegan meal then standard egg meal

Experimental group

Description:

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.

Treatment:

Other: Gastric emptying test