Test Meals for Spinal Cord Injuries

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Miami, Miami, FL
Spinal Cord Injuries
Test Meals - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: Before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days).

Baseline
Total percentage body fat
Day 7
Change in subjective appetite rating as measured by Hunger Series Visual Analogue Scale
Change in subjective appetite rating as measured by Palatability Series Visual Analogue Scale
Day 7
Change in postprandial Glucagon Peptide 1 (GLP-1)
Change in postprandial cholecystokinin (CKK)
Change in postprandial ghrelin
Change in postprandial peptide tyrosine tyrosine (PYY)
Up to seven days
Gastric emptying time
Upper gastrointestinal transit time

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control Group
1 of 2
Spinal Cord Injury Group
1 of 2
Active Control
Experimental Treatment

32 Total Participants · 2 Treatment Groups

Primary Treatment: Test Meals · No Placebo Group · N/A

Spinal Cord Injury Group
Other
Experimental Group · 1 Intervention: Test Meals · Intervention Types: Other
Control Group
Other
ActiveComparator Group · 1 Intervention: Test Meals · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days).
Closest Location: University of Miami · Miami, FL
Photo of University of Miami 1Photo of University of Miami 2Photo of University of Miami 3
1991First Recorded Clinical Trial
14 TrialsResearching Spinal Cord Injuries
621 CompletedClinical Trials

Who is running the clinical trial?

University of MiamiLead Sponsor
780 Previous Clinical Trials
381,730 Total Patients Enrolled
34 Trials studying Spinal Cord Injuries
3,297 Patients Enrolled for Spinal Cord Injuries
The Craig H. Neilsen FoundationOTHER
44 Previous Clinical Trials
2,494 Total Patients Enrolled
42 Trials studying Spinal Cord Injuries
2,443 Patients Enrolled for Spinal Cord Injuries
Gary J Farkas, PhDPrincipal InvestigatorUniversity of Miami

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to feed yourself.
You are taking a bowel care program every-other-day.
You have a SCI and have been hospitalized for at least 12 months post-injury.
You have an American Spinal Injury Association Impairment Scale score of 16 or more.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References