Clinical trial NCT05406739: Feeding Regulation in SCI
Official title: Physiological and Behavioral Regulation of Feeding After Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: gut
eating
appetite
hormone
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
First posted: 2022-06-06
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Gastric emptying time
timeFrame: Up to seven days
measure: Upper gastrointestinal transit time
timeFrame: Up to seven days
Secondary outcomes:
measure: Change in postprandial ghrelin
timeFrame: Before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days).
measure: Change in postprandial peptide tyrosine tyrosine (PYY)
timeFrame: Before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days).
measure: Change in postprandial cholecystokinin (CKK)
timeFrame: Before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days).
measure: Change in postprandial Glucagon Peptide 1 (GLP-1)
timeFrame: Before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days).
measure: Change in subjective appetite rating as measured by Palatability Series Visual Analogue Scale
timeFrame: Baseline and up to 7 days
measure: Change in subjective appetite rating as measured by Hunger Series Visual Analogue Scale
timeFrame: Baseline and up to 7 days
measure: Total percentage body fat
timeFrame: Baseline
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Gary J Farkas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
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.
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.
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.