Association Between Body Composition and Pain in Spinal Cord Injury

Sponsor

University of Miami (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05459207

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pain Inflammatory Response	Other: Moderate Fat Meal Other: High Fat Meal	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Aug 31, 2026

Anticipated Study Completion Date :

Aug 31, 2026

Arms and Interventions

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.

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

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

Other: High Fat Meal

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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-C
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Coral Gables	Florida	United States	33146

Sponsors and Collaborators

University of Miami

Investigators

Principal Investigator: Elizabeth Felix, PhD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elizabeth Roy Felix, Research Professor, University of Miami

ClinicalTrials.gov Identifier:

NCT05459207

Other Study ID Numbers:

20211078
90SCIMS0013

First Posted:

Jul 14, 2022

Last Update Posted:

Aug 18, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Spinal Cord Injuries

Study Results

No Results Posted as of Aug 18, 2022