Actively Recruiting
Food Intake and Thermogenesis in Men with High Spinal Cord Injury
Led by University of Miami · Updated on 2026-04-21
56
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
T
The Craig H. Neilsen Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand how food affects heart and metabolic health in men with and without spinal cord injury (SCI). The study focuses on men who are physically inactive and weight stable, comparing those with chronic high-level spinal cord injuries to those without. It is conducted by the University of Miami and examines how different meals impact energy use and hunger. Participants will be randomly assigned to one of three groups, each receiving a standardized meal with a different level of nutrient modification: low, moderate, or high. Each participant will attend one visit per week over three weeks, consuming a 500-gram meal during each visit. Visits last about six hours, and the study also includes a control meal condition with a 600-700 gram standardized meal served at all visits. During the study, researchers will measure diet-induced thermogenesis, hunger using a visual scale, and the amount of food consumed after the meals. Data will be collected during each intervention visit over the three-week period. Participants will be monitored for up to three weeks, with assessments focusing on how their bodies process food and how hungry they feel following each meal.
CONDITIONS
Brief Title
Food Intake and Thermogenesis in High Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged 18 to 65 years
- Physically inactive (less than 150 minutes per week of moderate to vigorous activity for the past 3 months)
- Weight stable within plus or minus 3 kilograms for the past 3 months
- For spinal cord injury (SCI) group: chronic SCI at least 1 year post-injury
- Motor-complete SCI classified as American Spinal Injury Association Impairment Scale (AIS) A or B
- SCI injury level at T6 or above with ability to feed oneself independently
You will not qualify if you...
- Uncompensated thyroid disease
- Diabetes
- Swallowing or gastrointestinal disorders
- Allergies or aversions to study foods or ingredients
- Use of prescribed prokinetic, antipsychotic, or anti-obesity medications
- For SCI group: incomplete SCI classified as AIS C or D
- Ventilator dependency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants consume a standardized meal with a nutrient modification during each visit. Visits occur once per week for 3 weeks, each lasting approximately 6 hours.
Weekly visits for 3 weeks, each visit approximately 6 hours (in-person)
Trial Site Locations
Total: 1 location
1
University of Miami - Miami Project to Cure Paralysis
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
G
Guillermo Mederos
G
Gary J Farkas, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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