Status:
COMPLETED
Feeding Regulation in SCI
Lead Sponsor:
University of Miami
Collaborating Sponsors:
The Craig H. Neilsen Foundation
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The overall purpose of this research is to understand the reasons why persons with spinal cord injuries eat more calories than they need to "burn", stay alive, and function. This research will investi...
Eligibility Criteria
Inclusion
- Spinal Cord Injury (SCI) Participants:
- Adults (≥ 18 years) with tetraplegia (C5-C8) or paraplegia (T1-L2) SCI
- Chronic SCI, denoted as ≥ 12 months post-injury
- American Spinal Injury Association Impairment Scale164 A, B, and C
- Persons with tetraplegia self-report they are able to feed themselves
- Self-report on a bowel care program every-other-day
- English speaking
- Control Group (Healthy) Participants:
- Adults (≥ 18 years) without a SCI (will be sex- and age-matched to persons with SCI)
- English speaking
Exclusion
- For All Participants:
- Currently on a weight loss program/diet and/or actively trying to lose weight
- Have a self-reported history of
- Diabetes
- Thyroid disease
- Gastrointestinal disease
- Previous abdominal surgery ≤ 3 months prior to the study
- Peripheral nervous system prosthesis
- Swallowing disorders
- Self-reported food allergies to or dislike the test meals.
- Self-reported use of a prokinetic agent, antipsychotic agent, or Glucagon like Peptide 1 (GLP-1) agonists
- Individuals who are not yet adults (infants, children, teenagers)
- Women that self-report they are pregnant or likely to become pregnant
- Prisoners
Key Trial Info
Start Date :
January 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2024
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT05406739
Start Date
January 5 2023
End Date
January 24 2024
Last Update
February 14 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Miami
Miami, Florida, United States, 33136