Feeding Regulation in SCI

Sponsor

University of Miami (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05406739

Collaborator

The Craig H. Neilsen Foundation (Other)

Enrollment

Location

Arms

22.2

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries	Other: Test Meals	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Physiological and Behavioral Regulation of Feeding After Spinal Cord Injury

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Aug 8, 2024

Anticipated Study Completion Date :

Aug 8, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Spinal Cord Injury Group Participants who have a spinal cord injury will receive two meals on two separate visits between five to seven days.	Other: Test Meals For the first meal, Participants will be fasted for 8 hours and will consume a test meal of 255 calories (120 g egg substitute [60 kcal]; 2 slices of bread [120 kcal] with 30 g strawberry jam [75 kcal]; 72% carbohydrate, 24% protein, 2% fat, and 2% fiber) with 120 mL of water. After five to seven days, participants will be fasted for 10 hours and will consume a second test meal of 510 calories (240 g egg substitute [120 kcal]; 4 slices of bread [240 kcal] with 60 g strawberry jam [150 kcal]; 72% carbohydrate, 24% protein, 2% fat, and 2% fiber) with 240 mL of water.
Active Comparator: Control Group Participants without a spinal cord injury will receive two meals on two separate visits between five to seven days.	Other: Test Meals For the first meal, Participants will be fasted for 8 hours and will consume a test meal of 255 calories (120 g egg substitute [60 kcal]; 2 slices of bread [120 kcal] with 30 g strawberry jam [75 kcal]; 72% carbohydrate, 24% protein, 2% fat, and 2% fiber) with 120 mL of water. After five to seven days, participants will be fasted for 10 hours and will consume a second test meal of 510 calories (240 g egg substitute [120 kcal]; 4 slices of bread [240 kcal] with 60 g strawberry jam [150 kcal]; 72% carbohydrate, 24% protein, 2% fat, and 2% fiber) with 240 mL of water.

Arm

Intervention/Treatment

Experimental: Spinal Cord Injury Group

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

Other: Test Meals

For the first meal, Participants will be fasted for 8 hours and will consume a test meal of 255 calories (120 g egg substitute [60 kcal]; 2 slices of bread [120 kcal] with 30 g strawberry jam [75 kcal]; 72% carbohydrate, 24% protein, 2% fat, and 2% fiber) with 120 mL of water. After five to seven days, participants will be fasted for 10 hours and will consume a second test meal of 510 calories (240 g egg substitute [120 kcal]; 4 slices of bread [240 kcal] with 60 g strawberry jam [150 kcal]; 72% carbohydrate, 24% protein, 2% fat, and 2% fiber) with 240 mL of water.

Active Comparator: Control Group

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

Other: Test Meals

Outcome Measures

Primary Outcome Measures

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

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 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 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 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 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

University of Miami
The Craig H. Neilsen Foundation

Investigators

Principal Investigator: Gary J Farkas, PhD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Gary Farkas, Postdoctoral Associate, University of Miami

ClinicalTrials.gov Identifier:

NCT05406739

Other Study ID Numbers:

20220407

First Posted:

Jun 6, 2022

Last Update Posted:

Jul 13, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gary Farkas, Postdoctoral Associate, University of Miami

Additional relevant MeSH terms:

Spinal Cord Injuries

Study Results

No Results Posted as of Jul 13, 2022