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Association Between Body Composition and Pain in Spinal Cord Injury

Primary Purpose

Pain, Inflammatory Response

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Moderate Fat Meal
High Fat Meal
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of MiamiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Moderate Fat Meal, Followed by High Fat Meal Group

High Fat Meal, Followed by Moderate Fat Meal Group

Arm Description

Participants will receive a moderate fat meal, followed by a high fat meal approximately seven days apart.

Participants will receive a high fat meal, followed by a moderate fat meal approximately seven days apart.

Outcomes

Primary Outcome Measures

peak change in Interleukin (IL)-6
analysis of blood samples taken after ingestion of meal challenge for level of IL-6 in picograms/milliliter
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

Secondary Outcome Measures

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

Full Information

First Posted
July 11, 2022
Last Updated
February 27, 2023
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT05459207
Brief Title
Association Between Body Composition and Pain in Spinal Cord Injury
Official Title
Association Among Body Composition, Chronic Pain, Evoked Pain Sensitivity, and Adiposity-related Systemic Inflammation in Individuals With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
August 31, 2027 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Inflammatory Response

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Moderate Fat Meal, Followed by High Fat Meal Group
Arm Type
Experimental
Arm Description
Participants will receive a moderate fat meal, followed by a high fat meal approximately seven days apart.
Arm Title
High Fat Meal, Followed by Moderate Fat Meal Group
Arm Type
Experimental
Arm Description
Participants will receive a high fat meal, followed by a moderate fat meal approximately seven days apart.
Intervention Type
Other
Intervention Name(s)
Moderate Fat Meal
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
High Fat Meal
Intervention Description
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 Outcome Measure Information:
Title
peak change in Interleukin (IL)-6
Description
analysis of blood samples taken after ingestion of meal challenge for level of IL-6 in picograms/milliliter
Time Frame
at 0, 40, 80, 160, 240, 320, and 400 minutes post meal ingestion
Title
peak change in evoked pain sensitivity
Description
measures of heat pain threshold (degrees Celcius), using the ascending method of limits via a 30mm2 surface thermode, obtained after ingestion of meal challenge
Time Frame
at 0, 40, 80, 160, 240, 320, and 400 minutes post meal ingestion
Secondary Outcome Measure Information:
Title
correlation coefficient between changes in IL-6 and evoked pain sensitivity
Description
correlation coefficient for relationship between changes in IL-6 and heat pain thresholds across time
Time Frame
at 0, 40, 80, 160, 240, 320, and 400 minutes post meal ingestion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Felix, PhD
Phone
305-243-4497
Email
efelix@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Felix, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Felix, PhD
Phone
305-243-4497
Email
efelix@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth Felix, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Association Between Body Composition and Pain in Spinal Cord Injury

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