How different meals affect metabolism and heat production after high spinal cord injury
Official title: Food Intake and Thermogenesis in High Spinal Cord Injury
Run by University of Miami · NCT07103993 · Data updated 2026-11-12
This study will see if different meal sizes change heart and metabolic responses in men with and without high spinal cord injury.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 56 (estimated) |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Status | Recruiting |
| Started | March 13, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | September 30, 2026 |
| Trial ID | NCT07103993 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men who are at least one year post-injury with motor-complete (AIS A or B) spinal cord injuries at T6 or above who are physically inactive and weight-stable, as well as similar men without SCI for the control group.
✕Probably not a fit
Women, people with diabetes, uncompensated thyroid disease, swallowing or GI pathologies, those with relevant food allergies or taking excluded medications, and those with incomplete SCI or ventilator dependence are unlikely to be eligible or to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Men with chronic, motor-complete spinal cord injuries at T6 or above and age-matched men without SCI will undergo controlled feeding sessions with low, moderate, high, and ad-libitum meal conditions. Researchers will measure cardiovascular and metabolic responses, including thermogenesis and postprandial changes, over the course of each visit. Participants must be physically inactive and weight-stable, and measurements are taken in person at the research center. The crossover design allows each participant to serve as their own control across meal conditions to directly compare responses.
Why it matters
Potential benefit: If successful, the results could help tailor meal-size and dietary guidance to improve cardiometabolic health in men with high spinal cord injury.
How similar studies have gone: Previous research has shown altered metabolic and thermogenic responses after SCI, but meal-size intervention studies in motor-complete, high-level SCI are limited, so this approach is partly novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: SCI and Controls * Men and Women * Physically inactive (\<200 minutes per week of moderate-vigorous activity intensity for the preceding 3 months) * Weight stable: body mass ±3 kilograms (kg) for past 3 months SCI Only * Chronic SCI (≥ 1-year post-injury) * Motor-complete SCI American Spinal Injury Association Impairment Scale (AIS) A and B * T6 injuries and above that can independently feed themselves Exclusion Criteria: SCI and Controls * Uncompensated thyroid disease * Diabetes * Swallowing or gastrointestinal pathologies * Allergies or aversions to foods/ingredients * Prescribed prokinetic, antipsychotic, or anti-obesity agents SCI Only * Incomplete SCI AIS C or D * Ventilator-dependent
Where it's running
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University of Miami - Miami Project to Cure Paralysis
Miami, Florida, United States Recruiting
Study contacts
- Principal investigator: Gary J Farkas, PhD — University of Miami
- Study coordinator: Guillermo Mederos
- Email: gxm1228@med.miami.edu
- Phone: (305) 243-4518
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.