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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 0, 40, 80, 160, 240, 320, and 400 minutes post meal ingestion

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

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

Primary outcome measures

peak change in Interleukin (IL)-6

peak change in evoked pain sensitivity

Secondary outcome measures

correlation coefficient between changes in IL-6 and evoked pain sensitivity

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

901 Previous Clinical Trials

409,946 Total Patients Enrolled

8 Trials studying Inflammation

527 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

Frequently Asked Questions

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

Could I possibly join this clinical trial based on my current condition?

"To be admitted to this trial, potential participants must suffer from pain and fall between the ages of 18-65 years old. The team intends to enroll 40 people in total."

Answered by AI

Does this research encompass individuals aged eighty and above?

"According to the inclusion criteria of this trial, only individuals aged 18-65 may apply. Additionally, there are 109 trials for minors and 573 for seniors."

Answered by AI

What is the aggregate patient count of this clinical trial?

"Affirmative. Clinicaltrials.gov displays that this medical trial is currently searching for volunteers to participate, after first being posted on January 1st 2023 and last edited November 22nd 2022. 40 patients are required at one site."

Answered by AI

Are any additional participants being accepted for this research experiment?

"As evidenced by clinicaltrials.gov, this medical trial is actively seeking participants. It was initially advertised on the 1st of January 2023 and last updated on November 22nd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Association Between Body Composition and Pain in Spinal Cord Injury

Elizabeth Felix 2023. "Association Between Body Composition and Pain in Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05459207.

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