CClinicalTrials.gg
RecruitingNCT07103993Updated Sep 30, 2026

Food Intake and Thermogenesis in High Spinal Cord Injury

An interventional study of Low meal condition and Moderate meal condition in SCI - Spinal Cord Injury, sponsored by University of Miami. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by University of Miami · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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).

02

Conditions studied

  • SCI - Spinal Cord Injury
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

SCI and Controls

  • Men and Women
  • Physically inactive (\<200 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

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Participant)
Enrollment
56 participants (estimated)

Study arms

  • Experimental
    Low meal condition group

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

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

  • Experimental
    Moderate meal condition group

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

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

  • Experimental
    High meal condition group

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

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

Interventions

  • OtherLow 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

  • OtherModerate 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.

  • OtherHigh 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.

  • OtherAd-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.

05

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

06

Study locations

1 of 1 sites recruiting
  • University of Miami - Miami Project to Cure Paralysis
    Miami, Florida 33136, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07103993
Lead sponsor
University of Miami
Collaborators
The Craig H. Neilsen Foundation
Responsible party
Gary Farkas (Assistant Professor, University of Miami) — Principal investigator
First posted
Aug 5, 2025
Start date
Mar 13, 2026
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 30, 2026

Study contacts

Guillermo Mederos
Contact
gxm1228@med.miami.edu
(305) 243-4518
Gary J Farkas, PhD
Contact
gjf50@med.miami.edu
(305) 243-4518
Gary J Farkas, PhD
principal investigator · University of Miami

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion