RecruitingNot ApplicableNCT05459207

Association Between Body Composition and Pain in Spinal Cord Injury

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


Sponsor

University of Miami

Enrollment

40 participants

Start Date

Feb 20, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria5

  • 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 Criteria6

  • 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

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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.


Locations(1)

University of Miami

Coral Gables, Florida, United States

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NCT05459207


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