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NCT Number: NCT07103993

Food Intake and Thermogenesis in High Spinal Cord Injury

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).

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Key information

Conditions

SCI - Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

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.

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.

Primary outcomes

  1. Diet induced thermogenesis (DIT)

    Time frame: 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.

  2. Hunger Series Visual Analog Scale

    Time frame: 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.

  3. Post ad-libitum energy intake measured in grams

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gary J Farkas, PhD

CONTACT

[email protected]

(305) 243-4518

Guillermo Mederos

CONTACT

[email protected]

(305) 243-4518

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • The Craig H. Neilsen Foundation

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2025
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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