Association Between Body Composition and Pain in Spinal Cord Injury

Study Overview
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Brief Summary
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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

Official Title
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Association Among Body Composition, Chronic Pain, Evoked Pain Sensitivity, and Adiposity-related Systemic Inflammation in Individuals With Spinal Cord Injury

Conditions
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Pain, Inflammatory Response

Intervention / Treatment
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* Other: Moderate Fat Meal
* Other: High Fat Meal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 years SCI 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate Fat Meal, Followed by High Fat Meal Group<br>Participants will receive a moderate fat meal, followed by a high fat meal approximately seven days apart. | Other: Moderate Fat Meal<br>* 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.<br>Other: High Fat Meal<br>* 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.<br>|
| Experimental: High Fat Meal, Followed by Moderate Fat Meal Group<br>Participants will receive a high fat meal, followed by a moderate fat meal approximately seven days apart. | Other: Moderate Fat Meal<br>* 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.<br>Other: High Fat Meal<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peak change in Interleukin (IL)-6 | analysis of blood samples taken after ingestion of meal challenge for level of IL-6 in picograms/milliliter | at 0, 40, 80, 160, 240, 320, and 400 minutes post meal ingestion | 
| peak change in evoked pain sensitivity | measures of heat pain threshold (degrees Celcius), using the ascending method of limits via a 30mm2 surface thermode, obtained after ingestion of meal challenge | at 0, 40, 80, 160, 240, 320, and 400 minutes post meal ingestion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | at 0, 40, 80, 160, 240, 320, and 400 minutes post meal ingestion |