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Feeding Regulation for Spinal Cord Injury

University of Miami, Miami, FL

Test MealsN/ARecruitingLed by Gary J Farkas, PhDResearch Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upbefore the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days).

Awards & highlights

No Placebo-Only Group

Study Summary

This trial will help researchers understand why people with spinal cord injuries often eat more calories than they need, in order to stay alive and function.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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Adults who are 18 years or older and have tetraplegia (C5-C8) or paraplegia (T1-L2) spinal cord injury.

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You have had a spinal cord injury for more than 12 months.

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You have specific levels of spinal cord injury according to the American Spinal Injury Association Impairment Scale.

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People who are unable to feed themselves due to paralysis in all four limbs.

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You have a bowel care routine that you follow every other day.

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We are looking for adults 18 years or older who do not have a spinal cord injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days).

This trial's timeline: 3 weeks for screening, Varies for treatment, and before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Gastric emptying time

Upper gastrointestinal transit time

Secondary outcome measures

Change in postprandial Glucagon Peptide 1 (GLP-1)

Change in postprandial cholecystokinin (CKK)

Change in postprandial ghrelin

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Spinal Cord Injury GroupExperimental Treatment1 Intervention

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

Group II: Control GroupActive Control1 Intervention

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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Craig H. Neilsen FoundationOTHER

52 Previous Clinical Trials

2,757 Total Patients Enrolled

University of MiamiLead Sponsor

876 Previous Clinical Trials

407,755 Total Patients Enrolled

Gary J Farkas, PhDPrincipal InvestigatorUniversity of Miami

Media Library

Test Meals Clinical Trial Eligibility Overview. Trial Name: NCT05406739 — N/A

Spinal Cord Injury Research Study Groups: Spinal Cord Injury Group, Control Group

Spinal Cord Injury Clinical Trial 2023: Test Meals Highlights & Side Effects. Trial Name: NCT05406739 — N/A

Test Meals 2023 Treatment Timeline for Medical Study. Trial Name: NCT05406739 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the intent of this clinical exploration?

"The main goal of this clinical trial, lasting up to a week, is to estimate gastric emptying time. Secondary measurements include changes in postprandial ghrelin (as determined by serum blood samples), total body fat percentage (measured through Dual x-ray absorptiometry DXA) and fluctuations in postprandial peptide tyrosine tyrosine PYY (also evaluated via serum blood samples)."

Answered by AI

Are additional participants being sought for the experiment?

"This research, which was posted at the start of 2021 and last updated in November 2022, is no longer recruiting patients. Nonetheless, there are 352 other trials that currently need participants."

Answered by AI