Gut-Brain Neural Coupling in Spinal Cord Injury
Part of paid clinical trials in Miami, Florida.
- Sponsor
- University of Miami
- Study ID
- NCT07052344
- Status
- Recruiting
Conditions
- SCI - Spinal Cord Injury
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Accepted
Interventions
- Preload condition — OTHERParticipants 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
- Ad-libitum control condition — OTHERParticipants 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.
Study Details
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).
Key Dates
- Start date
- Oct 29, 2025
- Status verified
- Nov 2025
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 28 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Pre-load Condition Meal GroupParticipants will be in this group for up to 2 weeks.
- Active Comparator: Ad-libitum Condition Meal GroupParticipants will be in this group for up to 2 weeks.
Primary Outcome Measure
Phase amplitude coupling (PAC) strength [ Time Frame: up to 2 weeks ]
Central Contacts
- Guillermo Mederos305-243-4518
- Gary J Farkas, PhD305-243-4518
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Miami - Miami Project to Cure Paralysis | Miami | Florida | 33136 | Gary J Farkas, PhD (PRINCIPAL_INVESTIGATOR) |
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