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| Name | Class |
|---|---|
| The Craig H. Neilsen Foundation | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal Cord Injury Group | Experimental | Participants who have a spinal cord injury will receive two meals on two separate visits between five to seven days. |
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| Control Group | Active Comparator | Participants without a spinal cord injury will receive two meals on two separate visits between five to seven days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Meals | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Spinal Cord Injury (SCI) Participants:
Control Group (Healthy) Participants:
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Gary J Farkas, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34551839 | Background | Farkas GJ, Sneij A, McMillan DW, Tiozzo E, Nash MS, Gater DR Jr. Energy expenditure and nutrient intake after spinal cord injury: a comprehensive review and practical recommendations. Br J Nutr. 2022 Sep 14;128(5):863-887. doi: 10.1017/S0007114521003822. Epub 2021 Sep 23. | |
| 33814888 | Background | Farkas GJ, Sneij A, Gater DR Jr. Dietetics After Spinal Cord Injury: Current Evidence and Future Perspectives. Top Spinal Cord Inj Rehabil. 2021;27(1):100-108. doi: 10.46292/sci20-00031. |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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|
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 |
| 33814887 | Background | Farkas GJ, Sneij A, Gater DR Jr. Energy Expenditure Following Spinal Cord Injury: A Delicate Balance. Top Spinal Cord Inj Rehabil. 2021;27(1):92-99. doi: 10.46292/sci20-00030. |
| 32226945 | Background | Farkas GJ, Gater DR. Energy Expenditure and Nutrition in Neurogenic Obesity following Spinal Cord Injury. J Phys Med Rehabil. 2020;2(1):11-13. No abstract available. |
| 31034249 | Background | Farkas GJ, Pitot MA, Gater Jr. DR. A Systematic Review of the Accuracy of Estimated and Measured Resting Metabolic Rate in Chronic Spinal Cord Injury. Int J Sport Nutr Exerc Metab. 2019 Sep 1;29(5):548-558. doi: 10.1123/ijsnem.2018-0242. |
| 30817378 | Background | Farkas GJ, Gorgey AS, Dolbow DR, Berg AS, Gater DR. Caloric Intake Relative to Total Daily Energy Expenditure Using a Spinal Cord Injury-Specific Correction Factor: An Analysis by Level of Injury. Am J Phys Med Rehabil. 2019 Nov;98(11):947-952. doi: 10.1097/PHM.0000000000001166. |
| 30420688 | Result | Farkas GJ, Pitot MA, Berg AS, Gater DR. Nutritional status in chronic spinal cord injury: a systematic review and meta-analysis. Spinal Cord. 2019 Jan;57(1):3-17. doi: 10.1038/s41393-018-0218-4. Epub 2018 Nov 12. |
| D014947 | Wounds and Injuries |