Dietary Fat Intake for Spinal Cord Injury
Trial Summary
What is the purpose of this trial?
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
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment involving dietary fat intake for spinal cord injury?
There is no direct evidence from the provided research articles supporting the effectiveness of dietary fat intake treatments specifically for spinal cord injury. However, one study suggests that dietary choices, like a high-fat diet, can influence metabolic outcomes, which are important for overall health in spinal cord injury patients.12345
Is a high-fat diet generally safe for humans?
Research on high-fat diets in humans shows they are generally safe, but they may increase cholesterol levels, which is a risk factor for heart disease. In studies with healthy individuals, high-fat diets were compared to low-fat diets, and the high-fat diets resulted in higher levels of LDL cholesterol (a type of bad cholesterol).12678
How does dietary fat intake treatment differ from other treatments for spinal cord injury?
This treatment is unique because it focuses on adjusting dietary fat intake, which is not a standard approach for spinal cord injury. Unlike typical treatments that might involve medication or physical therapy, this approach explores how different types and amounts of dietary fat can impact health outcomes, potentially offering a novel way to manage or improve conditions related to spinal cord injury.1791011
Research Team
Elizabeth Felix, PhD
Principal Investigator
University of Miami
Eligibility Criteria
This trial is for individuals aged 18-65 with chronic spinal cord injury (SCI) that happened at least two years ago, between C4 and L2 levels, and have varying degrees of impairment. They must speak English and be able to understand the study's risks. People are excluded if they have cognitive issues, systemic inflammation not related to weight, conditions preventing body composition measurement by DXA, vein access problems for blood draws, or if pregnant or imprisoned.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Meal Challenge
Participants receive a moderate fat meal followed by a high fat meal, or vice versa, approximately seven days apart
Follow-up
Participants are monitored for changes in inflammatory markers and evoked pain sensitivity after meal challenges
Treatment Details
Interventions
- High Fat Meal
- Moderate Fat Meal
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor