Feeding Regulation in SCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-05

Study Completion Date

2024-01-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Spinal Cord Injury Group

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

Group Type EXPERIMENTAL

Test Meals

Intervention Type OTHER

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.

Control Group

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

Group Type ACTIVE_COMPARATOR

Test Meals

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes