Feeding Regulation in SCI

Not Applicable

Completed

• Conditions: Spinal Cord Injuries
• Interventions: Other: Test Meals

• Registration Number: NCT05406739
• Lead Sponsor: University of Miami

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-01
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-06
• Study Start: 2023-01-05
• Primary Completion: 2024-01-24
• Study Completion: 2024-01-24
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Test Meals	Participants without a spinal cord injury will receive two meals on two separate visits between five to seven days.
Spinal Cord Injury Group	Test Meals	Participants who have a spinal cord injury will receive two meals on two separate visits between five to seven days.

Primary Outcome Measures

Name	Time	Method
Gastric emptying time	Up to seven days	Gastric emptying will be measured by the SmartPill Wireless Motility Capsule
Upper gastrointestinal transit time	Up to seven days	Upper gastrointestinal transit time will be measured by the SmartPill Wireless Motility Capsule

Secondary Outcome Measures

Name	Time	Method
Change in postprandial peptide tyrosine tyrosine (PYY)	Before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days).	Measured by serum blood samples
Change in postprandial Glucagon Peptide 1 (GLP-1)	Before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days).	Measured by serum blood samples
Change in postprandial ghrelin	Before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days).	Measured by serum blood samples
Change in postprandial cholecystokinin (CKK)	Before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days).	Measured by serum blood samples
Change in subjective appetite rating as measured by Palatability Series Visual Analogue Scale	Baseline and up to 7 days	Change in subjective appetite rating will be measured by Palatability Series Visual Analogue Scale that ranges from 0 mm as "not pleasant" to 100 mm as "extremely pleasant"
Change in subjective appetite rating as measured by Hunger Series Visual Analogue Scale	Baseline and up to 7 days	Change in subjective appetite rating will be measured by Hunger Series Visual Analogue Scale that ranges from 0 mm as "not at all hungry" to 100 mm as "totally/a lot/very hungry".
Total percentage body fat	Baseline	Measured by Dual x-ray absorptiometry (DXA)

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States