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Feeding Regulation in SCI

Primary Purpose

Spinal Cord Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Test Meals
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spinal Cord Injuries focused on measuring gut, eating, appetite, hormone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of MiamiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Spinal Cord Injury Group

Control Group

Arm Description

Participants who have a spinal cord injury will receive two meals on two separate visits between five to seven days.

Participants without a spinal cord injury will receive two meals on two separate visits between five to seven days.

Outcomes

Primary Outcome Measures

Gastric emptying time
Gastric emptying will be measured by the SmartPill Wireless Motility Capsule
Upper gastrointestinal transit time
Upper gastrointestinal transit time will be measured by the SmartPill Wireless Motility Capsule

Secondary Outcome Measures

Change in postprandial ghrelin
Measured by serum blood samples
Change in postprandial peptide tyrosine tyrosine (PYY)
Measured by serum blood samples
Change in postprandial cholecystokinin (CKK)
Measured by serum blood samples
Change in postprandial Glucagon Peptide 1 (GLP-1)
Measured by serum blood samples
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"
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".
Total percentage body fat
Measured by Dual x-ray absorptiometry (DXA)

Full Information

First Posted
June 1, 2022
Last Updated
January 6, 2023
Sponsor
University of Miami
Collaborators
The Craig H. Neilsen Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05406739
Brief Title
Feeding Regulation in SCI
Official Title
Physiological and Behavioral Regulation of Feeding After Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2023 (Actual)
Primary Completion Date
August 21, 2024 (Anticipated)
Study Completion Date
August 21, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
The Craig H. Neilsen Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
gut, eating, appetite, hormone

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spinal Cord Injury Group
Arm Type
Experimental
Arm Description
Participants who have a spinal cord injury will receive two meals on two separate visits between five to seven days.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participants without a spinal cord injury will receive two meals on two separate visits between five to seven days.
Intervention Type
Other
Intervention Name(s)
Test Meals
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gastric emptying time
Description
Gastric emptying will be measured by the SmartPill Wireless Motility Capsule
Time Frame
Up to seven days
Title
Upper gastrointestinal transit time
Description
Upper gastrointestinal transit time will be measured by the SmartPill Wireless Motility Capsule
Time Frame
Up to seven days
Secondary Outcome Measure Information:
Title
Change in postprandial ghrelin
Description
Measured by serum blood samples
Time Frame
Before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days).
Title
Change in postprandial peptide tyrosine tyrosine (PYY)
Description
Measured by serum blood samples
Time Frame
Before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days).
Title
Change in postprandial cholecystokinin (CKK)
Description
Measured by serum blood samples
Time Frame
Before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days).
Title
Change in postprandial Glucagon Peptide 1 (GLP-1)
Description
Measured by serum blood samples
Time Frame
Before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days).
Title
Change in subjective appetite rating as measured by Palatability Series Visual Analogue Scale
Description
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"
Time Frame
Baseline and up to 7 days
Title
Change in subjective appetite rating as measured by Hunger Series Visual Analogue Scale
Description
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".
Time Frame
Baseline and up to 7 days
Title
Total percentage body fat
Description
Measured by Dual x-ray absorptiometry (DXA)
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gary J Farkas, PhD
Phone
3052434518
Email
gjf50@med.miami.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dinorah Rodriguez, BSN
Phone
3052432797
Email
dinorah@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary J Farkas, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary J Farkas, PhD
Phone
305-243-4518
Email
gjf50@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Mark S Nash, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34551839
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.
Results Reference
background
PubMed Identifier
33814888
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.
Results Reference
background
PubMed Identifier
33814887
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.
Results Reference
background
PubMed Identifier
32226945
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.
Results Reference
background
PubMed Identifier
31034249
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.
Results Reference
background
PubMed Identifier
30817378
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.
Results Reference
background
PubMed Identifier
30420688
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;:
Results Reference
result

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Feeding Regulation in SCI

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