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

NCT06991036 | Completed

• 1 other identifier: 24-008112
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Emptying; Gastroparesis

Outcome Measures

Primary Outcomes (1)

• Gastric emptying T half

  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.

  Baseline, 1 week

Secondary Outcomes (2)

• Proportion emptied using the standard egg diet

  2 hours, 4 hours

• Proportion emptied using the vegan diet alternative

  2 hours, 4 hours

Study Arms (2)

Standard egg meal then vegan meal

EXPERIMENTAL

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.

Other: Gastric emptying test

Vegan meal then standard egg meal

EXPERIMENTAL

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.

Other: Gastric emptying test

Interventions

Gastric emptying test OTHER

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.

Standard egg meal then vegan meal; Vegan meal then standard egg meal

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Camilleri, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 25, 2025
• Study Start: February 3, 2025
• Primary Completion: April 16, 2025
• Study Completion: April 16, 2025
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)