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Test Meals for Spinal Cord Injury

N/A

Waitlist Available

Led By Gary J Farkas, PhD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

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

Must have

Adults (≥ 18 years) with tetraplegia (C5-C8) or paraplegia (T1-L2) SCI

Spinal Cord Injury (SCI) Participants: Adults (≥ 18 years) with tetraplegia (C5-C8) or paraplegia (T1-L2) SCI

Timeline

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).

Awards & highlights

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.

Who is the study for?

This trial is for adults with chronic spinal cord injury (SCI), specifically tetraplegia or paraplegia, who can feed themselves and follow a bowel care program. It's also open to non-SCI individuals matching the SCI participants in age and sex. People actively trying to lose weight, with diabetes, thyroid or gastrointestinal diseases, recent abdominal surgery, swallowing disorders, certain allergies or dislikes towards test meals are excluded.Check my eligibility

What is being tested?

The study aims to understand why individuals with SCI might consume more calories than needed by examining food digestion speed, energy-controlling hormones, and feelings of hunger post-meal. This will be assessed through 'test meals' and compared between those with and without SCI.See study design

What are the potential side effects?

Since this trial involves consuming test meals rather than medication interventions, side effects may include discomfort from eating unfamiliar foods or potential allergic reactions if unknown food sensitivities exist.

Eligibility Criteria

Inclusion Criteria

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

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I am an adult with paralysis affecting my limbs due to a spinal cord injury.

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I am an adult with spinal cord injury resulting in tetraplegia or paraplegia.

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My spinal injury is classified as ASIA A, B, or C.

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I am an adult over 18 years old and do not have a spinal cord injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline 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

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Craig H. Neilsen FoundationOTHER

55 Previous Clinical Trials

2,898 Total Patients Enrolled

University of MiamiLead Sponsor

899 Previous Clinical Trials

409,695 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