Association Between Body Composition and Pain in Spinal Cord Injury
NCT ID: NCT05459207
Last Updated: 2025-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-02-20
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Elizabeth Felix
Research Professor
Principal Investigators
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Elizabeth Felix, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Coral Gables, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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90SCIMS0013
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
20211078
Identifier Type: -
Identifier Source: org_study_id
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