Actively Recruiting
Association Among Body Composition, Chronic Pain, Evoked Pain Sensitivity, and Inflammation in People With Spinal Cord Injury
Led by University of Miami · Updated on 2026-03-19
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adults aged 18 to 70 years with chronic spinal cord injury to understand how body composition relates to pain, pain sensitivity, and inflammation after eating meals with different fat levels. The study aims to compare changes in inflammatory markers and pain sensitivity following a high-fat meal versus a moderate-fat meal, and to explore how body fat influences these responses. Participants will take part in two test sessions about a week apart, receiving either a moderate-fat liquid meal followed by a high-fat liquid meal, or vice versa. Both meals contain powdered protein and complex carbohydrates blended with coconut oil and peanut butter, adjusted to achieve the desired fat content for each meal type. During the study, blood samples will be collected at multiple time points up to 400 minutes after meal ingestion to measure changes in inflammatory markers, specifically Interleukin-6, and pain sensitivity responses. Researchers will analyze the peak changes and correlations between inflammation and pain sensitivity. The study involves randomized assignment to meal order and includes detailed monitoring and assessments over the test periods.
CONDITIONS
Brief Title
Association Between Body Composition and Pain in Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years
- Spinal cord injury at least 2 years prior to study entry
- Neurological level of injury between C4 and L2
- American Spinal Injury Association Impairment Scale (AIS) A-D
- English-speaking
You will not qualify if you...
- Cognitive dysfunction limiting understanding of study risks or ability to consent
- Chronic systemic inflammation unrelated to weight or adiposity (e.g., autoimmune diseases, active urinary tract infection, pressure injury greater than Stage 2)
- Conditions preventing body composition measurement by DXA (e.g., lower limb contracture greater than 15 degrees)
- Inability to obtain free-flowing blood from a superficial forearm or hand vein
- Pregnant women
- Prisoners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks
Participants receive two different liquid meals, a moderate fat meal and a high fat meal, approximately seven days apart to assess changes in inflammation and pain sensitivity.
2 visits (in-person) spaced about 7 days apart
Trial Site Locations
Total: 1 location
1
University of Miami
Coral Gables, Florida, United States, 33146
Actively Recruiting
Research Team
E
Elizabeth Felix, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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