Food Intake and Thermogenesis in High Spinal Cord Injury

University of Miami

Status: Begins enrollment this month

Conditions: SCI - Spinal Cord Injury

Treatments: Other: Ad-libitum control condition; Other: Moderate meal condition; Other: Low meal condition; Other: High meal condition

Study type: Interventional

Funder types: Other

Identifiers

NCT07103993

20250335

Details and patient eligibility

About

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).

Enrollment: 56 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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56 participants in 3 patient groups

Low meal condition group

Experimental group

Description:

Subjects will be in this group for up to 3 weeks.

Treatment:

Other: Low meal condition

Other: Ad-libitum control condition

Moderate meal condition group

Experimental group

Description:

Subjects will be in this group for up to 3 weeks.

Treatment:

Other: Moderate meal condition

Other: Ad-libitum control condition

High meal condition group

Experimental group

Description:

Subjects will be in this group for up to 3 weeks.

Treatment:

Other: High meal condition

Other: Ad-libitum control condition