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OpenTrials
Completed

NCT Number: NCT06991036

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Gastric emptying T half

    Time frame: 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 outcomes

  1. Proportion emptied using the standard egg diet

    Time frame: 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.

  2. Proportion emptied using the vegan diet alternative

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 25, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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