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

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

Study Overview

• Status: Recruiting
• Conditions: Pain; Inflammatory Response
• Intervention / Treatment: Other: Moderate Fat Meal; Other: High Fat Meal

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth Felix, PhD; Phone Number: 305-243-4497; Email: efelix@med.miami.edu

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Recruiting
      • University of Miami
      • Contact: Elizabeth Felix, PhD; Phone Number: 305-243-4497; Email: efelix@med.miami.edu
      • Principal Investigator: Elizabeth Felix, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Elizabeth Felix, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 20211078; 90SCIMS0013 (Other Grant/Funding Number: National Institute for Disability, Independent Living, and Rehabilitation Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No