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Dietary Fat Intake for Spinal Cord Injury

N/A
Recruiting
Led By Elizabeth Felix, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 0, 40, 80, 160, 240, 320, and 400 minutes post meal ingestion
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at how different types of fat affect pain and inflammation in people with spinal cord injuries.

Who is the study for?
This trial is for individuals aged 18-65 with chronic spinal cord injury (SCI) that happened at least two years ago, between C4 and L2 levels, and have varying degrees of impairment. They must speak English and be able to understand the study's risks. People are excluded if they have cognitive issues, systemic inflammation not related to weight, conditions preventing body composition measurement by DXA, vein access problems for blood draws, or if pregnant or imprisoned.
What is being tested?
The study aims to measure how a high-fat meal versus a moderate-fat meal affects pain sensitivity and inflammatory markers in people with SCI. It also looks at how body fat distribution influences these responses after eating different types of meals.
What are the potential side effects?
While the trial does not involve medication hence typical side effects are not expected; participants may experience discomfort from blood draws or potential digestive changes due to dietary fat content.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 0, 40, 80, 160, 240, 320, and 400 minutes post meal ingestion
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 0, 40, 80, 160, 240, 320, and 400 minutes post meal ingestion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
peak change in Interleukin (IL)-6
peak change in evoked pain sensitivity
Secondary study objectives
correlation coefficient between changes in IL-6 and evoked pain sensitivity

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
Group I: Moderate Fat Meal, Followed by High Fat Meal GroupExperimental Treatment2 Interventions
Participants will receive a moderate fat meal, followed by a high fat meal approximately seven days apart.
Group II: High Fat Meal, Followed by Moderate Fat Meal GroupExperimental Treatment2 Interventions
Participants will receive a high fat meal, followed by a moderate fat meal approximately seven days apart.

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
948 Previous Clinical Trials
427,804 Total Patients Enrolled
8 Trials studying Inflammation
404 Patients Enrolled for Inflammation
Elizabeth Felix, PhDPrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials
31 Total Patients Enrolled

Media Library

High Fat Meal Clinical Trial Eligibility Overview. Trial Name: NCT05459207 — N/A
Inflammation Research Study Groups: Moderate Fat Meal, Followed by High Fat Meal Group, High Fat Meal, Followed by Moderate Fat Meal Group
Inflammation Clinical Trial 2023: High Fat Meal Highlights & Side Effects. Trial Name: NCT05459207 — N/A
High Fat Meal 2023 Treatment Timeline for Medical Study. Trial Name: NCT05459207 — N/A
~24 spots leftby Aug 2027
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