Feeding Regulation in SCI

Spinal Cord Injuries Clinical Trial

Official title:

Physiological and Behavioral Regulation of Feeding After Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05406739
• Other study ID #: 20220407
• Status: Completed
• Phase: N/A
• Start date: January 5, 2023
• Est. completion date: January 24, 2024

Study information

• Verified date: February 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 24, 2024
• Est. primary completion date: January 24, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	The Craig H. Neilsen Foundation

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. Erratum In: Spinal Cord. 2019 Feb 11;: — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric emptying time	Gastric emptying will be measured by the SmartPill Wireless Motility Capsule	Up to seven days
Primary	Upper gastrointestinal transit time	Upper gastrointestinal transit time will be measured by the SmartPill Wireless Motility Capsule	Up to seven days
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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
Secondary	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
Secondary	Total percentage body fat	Measured by Dual x-ray absorptiometry (DXA)	Baseline