Feeding Regulation in SCI

February 13, 2024 updated by: Gary Farkas, University of Miami

Physiological and Behavioral Regulation of Feeding After Spinal Cord Injury

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric emptying time
Time Frame: Up to seven days
Gastric emptying will be measured by the SmartPill Wireless Motility Capsule
Up to seven days
Upper gastrointestinal transit time
Time Frame: Up to seven days
Upper gastrointestinal transit time will be measured by the SmartPill Wireless Motility Capsule
Up to seven days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
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
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)
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
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)
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
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
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"
Baseline and up to 7 days
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".
Baseline and up to 7 days
Total percentage body fat
Time Frame: Baseline
Measured by Dual x-ray absorptiometry (DXA)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

The Craig H. Neilsen Foundation

Investigators

  • Principal Investigator: Gary J Farkas, PhD, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2023

Primary Completion (Actual)

January 24, 2024

Study Completion (Actual)

January 24, 2024

Study Registration Dates

First Submitted

June 1, 2022

First Submitted That Met QC Criteria

June 1, 2022

First Posted (Actual)

June 6, 2022

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20220407

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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