An interventional study of Moderate Fat Meal and High Fat Meal in Pain and Inflammatory Response, sponsored by University of Miami. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by University of Miami · Not applicable, Interventional, and Basic science
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
2,219 studies on the registry are indexed under Pain; 915 are open to participants now.
This study's planned enrollment of 40 is below the median of 70 across 1,901 interventional studies indexed under Pain.
Browse Pain studies →University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive a moderate fat meal, followed by a high fat meal approximately seven days apart.
Other: Moderate Fat Meal · Other: High Fat Meal
Participants will receive a high fat meal, followed by a moderate fat meal approximately seven days apart.
Other: Moderate Fat Meal · Other: 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 normal/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 high-fat meal.
peak change in Interleukin (IL)-6
analysis of blood samples taken after ingestion of meal challenge for level of IL-6 in picograms/milliliter
Time frame: 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
Time frame: at 40, 80, 160, 240, 320, and 400 minutes post meal ingestion
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
Time frame: at 40, 80, 160, 240, 320, and 400 minutes post meal ingestion
Plan to share: No
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