NCT05459207

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
16mo left

Started Feb 2023

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Feb 2023Aug 2027

First Submitted

Initial submission to the registry

July 11, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

February 20, 2023

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

4.5 years

First QC Date

July 11, 2022

Last Update Submit

March 17, 2026

Conditions

PainInflammatory Response

Outcome Measures

Primary Outcomes (2)

  • peak change in Interleukin (IL)-6

    analysis of blood samples taken after ingestion of meal challenge for level of IL-6 in picograms/milliliter

    at 40, 80, 160, 240, 320, and 400 minutes post meal ingestion

  • peak change in evoked pain sensitivity

    measures of heat pain threshold (degrees Celsius), using the ascending method of limits via a 30mm2 surface thermode, obtained after ingestion of meal challenge

    at 40, 80, 160, 240, 320, and 400 minutes post meal ingestion

Secondary Outcomes (1)

  • correlation coefficient between changes in IL-6 and evoked pain sensitivity

    at 40, 80, 160, 240, 320, and 400 minutes post meal ingestion

Study Arms (2)

Moderate Fat Meal, Followed by High Fat Meal Group

EXPERIMENTAL

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

Other: Moderate Fat MealOther: High Fat Meal

High Fat Meal, Followed by Moderate Fat Meal Group

EXPERIMENTAL

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

Other: Moderate Fat MealOther: High Fat Meal

Interventions

Moderate Fat MealOTHER

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, Followed by Moderate Fat Meal GroupModerate Fat Meal, Followed by High Fat Meal Group
High Fat MealOTHER

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.

High Fat Meal, Followed by Moderate Fat Meal GroupModerate Fat Meal, Followed by High Fat Meal Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elizabeth Felix, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Felix, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

July 11, 2022

First Posted

July 14, 2022

Study Start

February 20, 2023

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)