Pain, Inflammatory Response
Conditions
Brief summary
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
Interventions
OTHERModerate Fat Meal
A liquid meal consisting of powdered protein and complex carbohydrates blended with coconut oil and peanut butter in ratios required to achieve the desired calorie and macronutrient distributions of a normal/moderate fat meal.
OTHERHigh Fat Meal
A liquid meal consisting of powdered protein and complex carbohydrates blended with coconut oil and peanut butter in ratios required to achieve the desired calorie and macronutrient distributions of a high-fat meal.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| peak change in Interleukin (IL)-6 | at 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 sensitivity | at 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| correlation coefficient between changes in IL-6 and evoked pain sensitivity | at 40, 80, 160, 240, 320, and 400 minutes post meal ingestion | correlation coefficient for relationship between changes in IL-6 and heat pain thresholds across time |
Countries
United States
Contacts
CONTACTElizabeth Felix, PhD
PRINCIPAL_INVESTIGATORElizabeth Felix, PhD
University of Miami
Outcome results
None listed