Feeding Regulation in SCI

University of Miami

Status: Completed

Conditions: Spinal Cord Injuries

Treatments: Other: Test Meals

Study type: Interventional

Funder types: Other

Identifiers

NCT05406739

20220407

Details and patient eligibility

About

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 investigate how quickly food moves through a participant's body, the hormones in the participant's body that control energy and digestion, and a participant's impressions of hunger after eating a meal. This will be compared in persons with and without a spinal cord injury.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Spinal Cord Injury (SCI) Participants:

1. Adults (≥ 18 years) with tetraplegia (C5-C8) or paraplegia (T1-L2) SCI
2. Chronic SCI, denoted as ≥ 12 months post-injury
3. American Spinal Injury Association Impairment Scale164 A, B, and C
4. Persons with tetraplegia self-report they are able to feed themselves
5. Self-report on a bowel care program every-other-day
6. English speaking

Control Group (Healthy) Participants:

1. Adults (≥ 18 years) without a SCI (will be sex- and age-matched to persons with SCI)
2. English speaking

Exclusion criteria

For All Participants:

1. Currently on a weight loss program/diet and/or actively trying to lose weight

2. 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

3. Self-reported food allergies to or dislike the test meals.

4. Self-reported use of a prokinetic agent, antipsychotic agent, or Glucagon like Peptide 1 (GLP-1) agonists

5. Individuals who are not yet adults (infants, children, teenagers)

6. Women that self-report they are pregnant or likely to become pregnant

7. Prisoners

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

Spinal Cord Injury Group

Experimental group

Description:

Participants who have a spinal cord injury will receive two meals on two separate visits between five to seven days.

Treatment:

Other: Test Meals

Control Group

Active Comparator group

Description:

Participants without a spinal cord injury will receive two meals on two separate visits between five to seven days.

Treatment:

Other: Test Meals