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NCT Number: NCT05459207

Association Between Body Composition and Pain in Spinal Cord Injury

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

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Key information

Conditions

Pain Inflammatory Response Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Coral Gables, Florida, 33146, United States

Location status: Recruiting

Location contact

Elizabeth Felix, PhD

CONTACT

[email protected]

305-243-4497

Elizabeth Felix, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moderate Fat Meal

Other

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.

high fat meal

Other

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.

Primary outcomes

  1. peak change in Interleukin (IL)-6

    Time frame: 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

  2. peak change in evoked pain sensitivity

    Time frame: 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 outcomes

  1. correlation coefficient between changes in IL-6 and evoked pain sensitivity

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Felix, PhD

CONTACT

[email protected]

305-243-4497

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2022
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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