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

NCT ID: NCT06991036

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-03
• Study Completion Date: 2025-04-16

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.

Conditions

Gastric Emptying; Gastroparesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Standard egg meal then vegan meal

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.

Group Type: EXPERIMENTAL

Gastric emptying test

Intervention Type: 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.

Vegan meal then standard egg meal

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.

Group Type: EXPERIMENTAL

Gastric emptying test

Intervention Type: 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.

Interventions

Gastric emptying test

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Michael Camilleri, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Camilleri, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

24-008112

Identifier Type: -

Identifier Source: org_study_id