Feeding Regulation in SCI

Study Overview
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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.

Official Title
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Physiological and Behavioral Regulation of Feeding After Spinal Cord Injury

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Other: Test Meals


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal Cord Injury Group<br>Participants who have a spinal cord injury will receive two meals on two separate visits between five to seven days. | Other: Test Meals<br>* 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.<br>|
| Active Comparator: Control Group<br>Participants without a spinal cord injury will receive two meals on two separate visits between five to seven days. | Other: Test Meals<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying time | Gastric emptying will be measured by the SmartPill Wireless Motility Capsule | Up to seven days | 
| Upper gastrointestinal transit time | Upper gastrointestinal transit time will be measured by the SmartPill Wireless Motility Capsule | Up to seven days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in postprandial ghrelin | Measured by serum blood samples | Before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days). | 
| Change in postprandial peptide tyrosine tyrosine (PYY) | Measured by serum blood samples | Before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days). | 
| Change in postprandial cholecystokinin (CKK) | Measured by serum blood samples | Before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days). | 
| Change in postprandial Glucagon Peptide 1 (GLP-1) | Measured by serum blood samples | Before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days). | 
| Change in subjective appetite rating as measured by Palatability Series Visual Analogue Scale | 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 | Baseline and up to 7 days | 
| Change in subjective appetite rating as measured by Hunger Series Visual Analogue Scale | 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. | Baseline and up to 7 days | 
| Total percentage body fat | Measured by Dual x-ray absorptiometry (DXA) | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gut, eating, appetite, hormone