Association Between Body Composition and Pain in Spinal Cord Injury
Recruiting · NCT05459207 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Miami
View the official record on ClinicalTrials.gov →Interventions studied
High Fat MealModerate Fat Meal
What this trial is about
The purposes of the study are to quantify and compare relationships among acute changes in inflammatory markers and evoked pain sensitivity after a high-fat meal (HFM) challenge, compared to a moderate-fat meal challenge, and explore the influence of body composition on these responses, in individuals with chronic spinal cord injury
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed across 1 US state.
- University of Miami - Coral Gables, Florida, United States