Spinal Cord Injuries
Conditions
Keywords
gut, eating, appetite, hormone
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.
Interventions
OTHERTest 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.
Sponsors
The Craig H. Neilsen Foundation
University of Miami
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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) |
| 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 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 |
Countries
United States
Outcome results
None listed