Association Between Body Composition and Pain in Spinal Cord Injury

Not Applicable

Recruiting

• Conditions: Pain; Inflammatory Response
• Interventions: Other: Moderate Fat Meal; Other: High Fat Meal

• Registration Number: NCT05459207
• Lead Sponsor: University of Miami

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-11
• Study First Submitted QC: 2022-07-11
• Study First Posted: 2022-07-14
• Study Start: 2023-02-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-17
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Moderate Fat Meal, Followed by High Fat Meal Group	Moderate Fat Meal	Participants will receive a moderate fat meal, followed by a high fat meal approximately seven days apart.
High Fat Meal, Followed by Moderate Fat Meal Group	Moderate Fat Meal	Participants will receive a high fat meal, followed by a moderate fat meal approximately seven days apart.
High Fat Meal, Followed by Moderate Fat Meal Group	High Fat Meal	Participants will receive a high fat meal, followed by a moderate fat meal approximately seven days apart.
Moderate Fat Meal, Followed by High Fat Meal Group	High Fat Meal	Participants will receive a moderate fat meal, followed by a high fat meal approximately seven days apart.

Primary Outcome Measures

Name	Time	Method
peak change in Interleukin (IL)-6	at 0, 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
peak change in evoked pain sensitivity	at 0, 40, 80, 160, 240, 320, and 400 minutes post meal ingestion	measures of heat pain threshold (degrees Celcius), using the ascending method of limits via a 30mm2 surface thermode, obtained after ingestion of meal challenge

Secondary Outcome Measures

Name	Time	Method
correlation coefficient between changes in IL-6 and evoked pain sensitivity	at 0, 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

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Coral Gables, Florida, United States