Food Intake and Thermogenesis in High Spinal Cord Injury

NCT07103993 | Recruiting

• 1 other identifier: 20250335
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Diet induced thermogenesis (DIT)

  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.

  up to 3 weeks (collected during each of the intervention visits)

• Hunger Series Visual Analog Scale

  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.

  up to 3 weeks (collected during each of the intervention visits)

• Post ad-libitum energy intake measured in grams

  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.

  up to 3 weeks (collected during each of the intervention visits)

Study Arms (3)

Low meal condition group

EXPERIMENTAL

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

Other: Low meal condition; Other: Ad-libitum control condition

Moderate meal condition group

EXPERIMENTAL

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

Other: Moderate meal condition; Other: Ad-libitum control condition

High meal condition group

EXPERIMENTAL

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

Other: High meal condition; Other: Ad-libitum control condition

Interventions

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.

High meal condition group

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.

High meal condition group; Low meal condition group; Moderate meal condition group

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

Low meal condition group

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.

Moderate meal condition group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Male subjects
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• The Craig H. Neilsen Foundation: collaborator

Study Sites (1)

University of Miami - Miami Project to Cure Paralysis

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Gary J Farkas, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillermo Mederos

CONTACT

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

Gary J Farkas, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: March 13, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)