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 — OTHER
    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
  • Ad-libitum control condition — OTHER
    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.

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 Group
    Participants will be in this group for up to 2 weeks.
  • Active Comparator: Ad-libitum Condition Meal Group
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Miami - Miami Project to Cure ParalysisMiamiFlorida33136
Gary J Farkas, PhD
305-243-4518
Guillermo Mederos
305-243-3543
Gary J Farkas, PhD (PRINCIPAL_INVESTIGATOR)

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