What this study is
The purpose of this research is to determine the effects of food on cardiovascular and metabolic health in men with and without spinal cord injury (SCI).
What's being tested
- Low meal condition
Intervention · OTHER
Participants will consume a standardized meal (500 grams) with a low nutrient modification one time at one visit. Participants will attend one visit per week for 3 weeks. Each is visit separated by one week and each visit will take approximately 6 hours
- Moderate meal condition
Intervention · OTHER
Participants will consume a standardized meal (500 grams) with a moderate nutrient modification one time at one visit. Participants will attend one visit per week for 3 weeks. Each is visit separated by one week and each visit will take approximately 6 hours.
- High meal condition
Intervention · OTHER
Participants will consume a standardized meal (500 grams) with a high nutrient modification one time at one visit. Participants will attend one visit per week for 3 weeks. Each is visit separated by one week and each visit will take approximately 6 hours.
- Ad-libitum control condition
Intervention · OTHER
The ad-libitum meal consists of 600-700 g of a standardized control meal one time at all visits. Participants will attend one visit per week for 3 weeks. Each visit is separated by one week and each visit will take approximately 6 hours.
Study details
- Sponsor
- University of Miami
- Conditions
- SCI - Spinal Cord Injury
- Enrolling
- 56 people
- Starts
- 2026-03-13
- Est. completion
- 2027-12-31
- Design
- Single-blind, randomized, sequential groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 70 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Miami - Miami Project to Cure Paralysis
Miami, Florida, United States
- Gary J Farkas, PhD · Contact305-243-4518gjf50@med.miami.edu
- Guillermo Mederos · Contact305-243-3543gxm1228@med.miami.edu
- Gary J Farkas, PhD · Principal investigator
Recruiting
Study team
Sponsor
University of Miami
Study ID 20250335
Principal investigator
Gary J Farkas, PhD
University of Miami
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.