Recruiting

Observational Study

Sponsor:

University of Miami

Code:

NCT05459207

Conditions

Pain

Inflammatory Response

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Moderate Fat Meal

High Fat Meal

Study Details

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

Conditions

Pain

Inflammatory Response

Study ID

NCT05459207

Start date

Feb 20, 2023

Status verified date

Mar, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18-70 years
  • Spinal cord injury 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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Elizabeth Felix, PhD

305-243-4497efelix@med.miami.edu

Locations

University of Miami

Recruiting

Coral Gables, Florida, United States, 33146

Contacts

Elizabeth Felix, PhD

305-243-4497efelix@med.miami.edu

Principal Investigator:

Elizabeth Felix, PhD

More Information

Sponsor

University of Miami

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-03-19.