RecruitingNot ApplicableNCT07103993

Food Intake and Thermogenesis in High Spinal Cord Injury


Sponsor

University of Miami

Enrollment

56 participants

Start Date

Mar 13, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 65 Years

Inclusion Criteria8

  • 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 Criteria9

  • 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

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Interventions

OTHERLow 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

OTHERModerate 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.

OTHERHigh 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.

OTHERAd-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.


Locations(1)

University of Miami - Miami Project to Cure Paralysis

Miami, Florida, United States

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NCT07103993


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