Recruiting

Cardiovascular Health

Sponsor:

University of Miami

Code:

NCT07103993

Conditions

SCI - Spinal Cord Injury

Eligibility Criteria

Sex: Male

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Low meal condition

Moderate meal condition

High meal condition

Ad-libitum control condition

Study Details

Brief 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).

Conditions

SCI - Spinal Cord Injury

Study ID

NCT07103993

Start date

Mar 13, 2026

Status verified date

Feb, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

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

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.

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.

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 measure

  • 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) ]

Central Contacts and Locations

Central contacts

Guillermo Mederos

(305) 243-4518gxm1228@med.miami.edu

Gary J Farkas, PhD

(305) 243-4518gjf50@med.miami.edu

Locations

University of Miami - Miami Project to Cure Paralysis

Recruiting

Miami, Florida, United States, 33136

Contacts

Gary J Farkas, PhD

305-243-4518gjf50@med.miami.edu

Guillermo Mederos

305-243-3543gxm1228@med.miami.edu

Principal Investigator:

Gary J Farkas, PhD

More Information

Sponsor

University of Miami

Last update posted

Apr 21, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Miami on 2026-04-21.