NCT06991036

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2025-02-03
• Primary completion: 2025-04-16
• Completion: 2025-04-16
• First posted: 2025-05-25
• Last updated: 2025-05-25

Locations

1 site across 1 country: United States