Food Intake and Thermogenesis in High Spinal Cord Injury

Not Applicable

Not yet recruiting

• Conditions: SCI - Spinal Cord Injury

• Registration Number: NCT07103993
• Lead Sponsor: University of Miami

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-29
• Study First Submitted QC: 2025-07-29
• Last Update Submitted: 2025-07-29
• Study First Posted: 2025-08-05
• Last Update Posted: 2025-08-05
• Study Start: 2025-10-01
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 56

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Diet induced thermogenesis (DIT)	up to 3 weeks (collected during each of the intervention visits)	Diet-induced thermogenesis (DIT) will be measured using indirect calorimetry. A portable mask-based metabolic system, which will measure expired air to calculate dietary-induced thermogenesis defined as the energy expended above resting and the proportion of meal energy expended postprandially (postprandial kilocalorie (kcal) expended/total meal kcal) where a higher value means more energy is expended.
Hunger Series Visual Analog Scale	up to 3 weeks (collected during each of the intervention visits)	Satiety will be measured using the Hunger Series Visual Analog Scale (HSVAS), which assesses subjective appetite. Each scale is defined at 0 as "not at all hungry" and 100 as "totally/a lot/very hungry". A sum score will be calculated.
Post ad-libitum energy intake measured in grams	up to 3 weeks (collected during each of the intervention visits)	This value will be expressed as a ratio of energy consumed to energy requirements (energy intake/energy requirements x 100) and will be recorded in grams.

Trial Locations

Locations (1)

University of Miami - Miami Project to Cure Paralysis; 🇺🇸 Miami, Florida, United States