NCT07052344

Gut-Brain Neural Coupling in Spinal Cord Injury

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research is to determine the effects of food on brain and stomach activity in persons with and without spinal cord injury (SCI).

Conditions

• SCI - Spinal Cord Injury

Interventions

Type	Name	Description
OTHER	Preload condition	Participants will consume a fixed compulsory preload meal of Campbell's Tomato soup (\~300 grams) 30 minutes after the baseline assessments. Fifteen minutes after consuming the preload meal, participants will receive the ad libitum test meal, consisting of a pre-weighed serving of Stouffer's Macaroni and Cheese (\~700 g).The pre-load condition will be completed at only one of two visits. Participation will be up to 2 weeks with the visits separated by up to 2 weeks. Duration for the pre-load condition visit will be up to 6 hours
OTHER	Ad-libitum control condition	Participants will only consume the ad libitum test meal, which consists of a pre-weighted serving of Stouffer's Macaroni and Cheese (\~700 g). The ad-libitum meal will be consumed at both visits. Participation will be up to 2 weeks with the visits separated by up to 2 weeks. The ad-libitum control condition visit will take up to 2 hours.

Timeline

• Start date: 2025-10-29
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-07-04
• Last updated: 2025-11-25

Locations

1 site across 1 country: United States