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Understanding Pain and Diet in Spinal Cord Injury

This study is looking at how different types of meals affect pain and inflammation in people with chronic spinal cord injury. Researchers want to see if a High Fat Meal or a Moderate Fat Meal changes inflammatory markers (like IL-6, a protein involved in inflammation) and how sensitive you are to pain. They also want to understand how your body composition (like how much fat or muscle you have) might influence these responses. The study aims to enroll 40 participants, aged 18-70, who have had a spinal cord injury for at least two years. Success will be measured by changes in IL-6 and pain sensitivity after eating these meals. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 40 participants. It compares responses to a Moderate Fat Meal versus a High Fat Meal.
What's involved
You would ingest either a Moderate Fat Meal or a High Fat Meal. Researchers will measure changes in IL-6 and pain sensitivity at several time points after the meal.
Compensation
Not stated in the trial record.
Follow-up
Measurements will be taken for up to 400 minutes (about 6.5 hours) after meal ingestion.

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NCT05459207

Association Between Body Composition and Pain in Spinal Cord Injury

Recruiting
NAAges 18–70InterventionalBasic science
University of Miami
~40 participants
Updated 2026-03-19 on ClinicalTrials.gov
What's tested:Moderate Fat MealHigh Fat Meal

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
peak change in Interleukin (IL)-6
Measured over at 40, 80, 160, 240, 320, and 400 minutes post meal ingestion
+1 more outcome measured

Conditions

Pain
Inflammatory Response

Explore related trials

Spinal Cord Injury

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Elizabeth Felix, PhD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Elizabeth Felix, PhD
[email protected]
305-243-4497
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 18-70 years
Spinal cord injury occurring at least 2 years prior to study entry
Neurological level of injury (LOI) between C4 and L2
American Spinal Injury Association Impairment Scale (AIS) A-D
English-speaking.

Exclusion

Cognitive dysfunction that limits ability to adequately understand the risks of the study or are otherwise unable to consent
Health conditions associated with chronic systemic inflammation unrelated to weight or adiposity (e.g., systemic autoimmune diseases, recurrent or active urinary tract infection, pressure injury \> Stage 2)
Conditions that preclude measurement of body composition by dual-energy x-ray absorptiometry (DXA; e.g., lower limb contracture \> 15 degrees)
Inability to obtain free-flowing blood from a superficial forearm or hand vein
Pregnant women
Prisoners

What this trial measures

  • peak change in Interleukin (IL)-6at 40, 80, 160, 240, 320, and 400 minutes post meal ingestion

    analysis of blood samples taken after ingestion of meal challenge for level of IL-6 in picograms/milliliter

  • peak change in evoked pain sensitivityat 40, 80, 160, 240, 320, and 400 minutes post meal ingestion

    measures of heat pain threshold (degrees Celsius), using the ascending method of limits via a 30mm2 surface thermode, obtained after ingestion of meal challenge