Food Intake and Thermogenesis in High Spinal Cord Injury

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07103993
Status
Recruiting
Apply to this trial

Conditions

  • SCI - Spinal Cord Injury

Eligibility Criteria

Sex
MALE
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Low meal condition — 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 — 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 — 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 — 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

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).

Key Dates

Start date
Mar 13, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Low meal condition group
    Subjects will be in this group for up to 3 weeks.
  • Experimental: Moderate meal condition group
    Subjects will be in this group for up to 3 weeks.
  • Experimental: High meal condition group
    Subjects will be in this group for up to 3 weeks.

Primary Outcome Measure

Diet induced thermogenesis (DIT) [ Time Frame: up to 3 weeks (collected during each of the intervention visits) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Miami - Miami Project to Cure ParalysisMiamiFlorida33136
Gary J Farkas, PhD
[email protected]
305-243-4518
Guillermo Mederos
[email protected]
305-243-3543
Gary J Farkas, PhD (PRINCIPAL_INVESTIGATOR)

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University of Miami - Miami Project to Cure Paralysis· Miami, FL

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