Association Between Body Composition and Pain in Spinal Cord Injury

Part of paid clinical trials in Coral Gables, Florida.

Sponsor
University of Miami
Study ID
NCT05459207
Status
Recruiting
Apply to this trial

Conditions

  • Inflammatory Response
  • Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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

Key Dates

Start date
Feb 20, 2023
Status verified
Mar 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • 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.
  • 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.

Primary Outcome Measure

peak change in Interleukin (IL)-6 [ Time Frame: at 40, 80, 160, 240, 320, and 400 minutes post meal ingestion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiCoral GablesFlorida33146
Elizabeth Felix, PhD
[email protected]
305-243-4497
Elizabeth Felix, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Coral Gables, FL

By research site
University of Miami· Coral Gables, FL

Related Studies