PainNCT05459207
Association Between Body Composition and Pain in Spinal Cord Injury
A study testing Moderate Fat Meal and High Fat Meal in people with Pain and Inflammatory Response, run by University of Miami at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain, Inflammatory Response
- What is being tested?
- Moderate Fat Meal and High Fat Meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2023to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Coral Gables, Florida, 33146
Elizabeth Felix, PhD, 305-243-4497, efelix@med.miami.edu
Elizabeth Felix, PhD
About this study
Official title: Association Among Body Composition, Chronic Pain, Evoked Pain Sensitivity, and Adiposity-related Systemic Inflammation in Individuals With Spinal Cord Injury
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
- Being tested
- Moderate Fat Meal, High Fat Meal
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Moderate Fat Meal; Other: 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. Receives: Other: Moderate Fat Meal; Other: High Fat Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak change in Interleukin (IL)-6
analysis of blood samples taken after ingestion of meal challenge for level of IL-6 in picograms/milliliter
Measured: 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
Measured: 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
correlation coefficient for relationship between changes in IL-6 and heat pain thresholds across time
Measured: at 40, 80, 160, 240, 320, and 400 minutes post meal ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start20 Feb 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Felix, University of Miami
- Investigators
- Elizabeth Felix, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459207
- Sponsor's protocol ID
- 20211078
- Other IDs
- 90SCIMS0013
- Status last verified
- Mar 2026
- First submitted
- 11 Jul 2022
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Among Body Composition, Chronic Pain, Evoked Pain Sensitivity, and Adiposity-related Systemic Inflammation in Individuals With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05459207
- Acronym / sponsor ID
- 20211078
- Conditions
- Pain, Inflammatory Response
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Fat Meal, Followed by High Fat Meal Group | Experimental | Other: Moderate Fat Meal, Other: High Fat MealParticipants will receive a moderate fat meal, followed by a high fat meal approximately seven days apart. |
| High Fat Meal, Followed by Moderate Fat Meal Group | Experimental | Other: Moderate Fat Meal, Other: High Fat MealParticipants will receive a high fat meal, followed by a moderate fat meal approximately seven days apart. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate Fat MealA 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, Followed by Moderate Fat Meal Group, Moderate Fat Meal, Followed by High Fat Meal Group |
| High Fat MealA 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. | Other | High Fat Meal, Followed by Moderate Fat Meal Group, Moderate Fat Meal, Followed by High Fat Meal Group |
Primary outcome
peak change in Interleukin (IL)-6
Time frame: at 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
Time frame: at 40, 80, 160, 240, 320, and 400 minutes post meal ingestion
measures of heat pain threshold (degrees Celsius), using the ascending method of limits via a 30mm2 surface thermode, obtained after ingestion of meal challenge
1 secondary outcome
correlation coefficient between changes in IL-6 and evoked pain sensitivity
Time frame: at 40, 80, 160, 240, 320, and 400 minutes post meal ingestion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Felix, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Fat Meal and High Fat Meal in people with Pain and Inflammatory Response, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Felix, PhD (305-243-4497, efelix@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peak change in Interleukin (IL)-6 (time frame: at 40, 80, 160, 240, 320, and 400 minutes post meal ingestion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.