Association Between Body Composition and Pain in Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Miami
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Moderate Fat Meal
Other interventionA 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.
High Fat Meal
Other interventionA 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Moderate Fat Meal, Followed by High Fat Meal GroupExperimental treatment 2 interventions
Group B: High Fat Meal, Followed by Moderate Fat Meal GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
peak change in Interleukin (IL)-6
analysis of blood samples taken after ingestion of meal challenge for level of IL-6 in picograms/milliliter
Time frame
at 40, 80, 160, 240, 320, and 400 minutes post meal ingestion2
peak change in evoked pain sensitivity
measures of heat pain threshold (degrees Celsius), using the ascending method of limits via a 30mm2 surface thermode, obtained after ingestion of meal challenge
Time frame
at 40, 80, 160, 240, 320, and 400 minutes post meal ingestionSecondary outcomes
1
correlation coefficient between changes in IL-6 and evoked pain sensitivity
correlation coefficient for relationship between changes in IL-6 and heat pain thresholds across time
Time frame
at 40, 80, 160, 240, 320, and 400 minutes post meal ingestionSponsors and contacts
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Source ClinicalTrials.gov