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Feeding Regulation in SCI

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ClinicalTrials.gov Identifier: NCT05406739
Recruitment Status : Recruiting
First Posted : June 6, 2022
Last Update Posted : January 9, 2023
Sponsor:
Collaborator:
The Craig H. Neilsen Foundation
Information provided by (Responsible Party):
Gary Farkas, University of Miami

Study Description
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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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: Test Meals Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Physiological and Behavioral Regulation of Feeding After Spinal Cord Injury
Actual Study Start Date : January 5, 2023
Estimated Primary Completion Date : August 21, 2024
Estimated Study Completion Date : August 21, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Spinal Cord Injury Group
Participants who have a spinal cord injury will receive two meals on two separate visits between five to seven days.
 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.
Active Comparator: Control Group
Participants without a spinal cord injury will receive two meals on two separate visits between five to seven days.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Gastric emptying time [ Time Frame: Up to seven days ]
    Gastric emptying will be measured by the SmartPill Wireless Motility Capsule

  2. Upper gastrointestinal transit time [ Time Frame: Up to seven days ]
    Upper gastrointestinal transit time will be measured by the SmartPill Wireless Motility Capsule


Secondary Outcome Measures :
  1. Change in postprandial ghrelin [ 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). ]
    Measured by serum blood samples

  2. Change in postprandial peptide tyrosine tyrosine (PYY) [ 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). ]
    Measured by serum blood samples

  3. Change in postprandial cholecystokinin (CKK) [ 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). ]
    Measured by serum blood samples

  4. Change in postprandial Glucagon Peptide 1 (GLP-1) [ 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). ]
    Measured by serum blood samples

  5. Change in subjective appetite rating as measured by Palatability Series Visual Analogue Scale [ Time Frame: 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"

  6. Change in subjective appetite rating as measured by Hunger Series Visual Analogue Scale [ Time Frame: 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".

  7. Total percentage body fat [ Time Frame: Baseline ]
    Measured by Dual x-ray absorptiometry (DXA)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05406739


Contacts
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Contact: Gary J Farkas, PhD 3052434518 gjf50@med.miami.edu
Contact: Dinorah Rodriguez, BSN 3052432797 dinorah@med.miami.edu

Locations
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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Gary J Farkas, PhD    305-243-4518    gjf50@med.miami.edu   
Sub-Investigator: Mark S Nash, PhD         
Sponsors and Collaborators
University of Miami
The Craig H. Neilsen Foundation
Investigators
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Principal Investigator: Gary J Farkas, PhD University of Miami
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Gary Farkas, Postdoctoral Associate, University of Miami
ClinicalTrials.gov Identifier: NCT05406739    
Other Study ID Numbers: 20220407
First Posted: June 6, 2022    Key Record Dates
Last Update Posted: January 9, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gary Farkas, University of Miami:
gut
eating
appetite
hormone
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries