Recruiting NCT07103993
Food Intake and Thermogenesis in High Spinal Cord Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low meal condition, Moderate meal condition, High meal condition, Ad-libitum control condition.
- Who it may be relevant to
- Registry conditions: SCI - Spinal Cord Injury. Basic parameters: 18 years — 65 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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).
Interventions
- Other Low meal condition
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 - Other Moderate meal condition
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. - Other High meal condition
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. - Other Ad-libitum control condition
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.
Primary outcome measures
- Diet induced thermogenesis (DIT) [Time frame: up to 3 weeks (collected during each of the intervention visits)]
- Hunger Series Visual Analog Scale [Time frame: up to 3 weeks (collected during each of the intervention visits)]
- Post ad-libitum energy intake measured in grams [Time frame: up to 3 weeks (collected during each of the intervention visits)]
Eligibility criteria
Inclusion criteria
SCI and Controls
- Men
- Physically inactive (<150 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Miami - Miami Project to Cure Paralysis — Miami
Identifiers
NCT: NCT07103993 · 20250335