SCI - Spinal Cord InjuryNCT07103993
Food Intake and Thermogenesis in High Spinal Cord Injury
A study testing Low meal condition, Moderate meal condition and High meal condition in people with SCI - Spinal Cord Injury, run by University of Miami at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- SCI - Spinal Cord Injury
- What is being tested?
- Low meal condition, Moderate meal condition and High meal condition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- SCI and Controls
- Uncompensated thyroid disease
- Diabetes
- Swallowing or gastrointestinal pathologies
- Allergies or aversions to foods/ingredients
- Prescribed prokinetic, antipsychotic, or anti-obesity agents
Show all 9Show fewer
- SCI Only
- Incomplete SCI AIS C or D
- Ventilator-dependent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami - Miami Project to Cure Paralysis
Miami, Florida, 33136
Gary J Farkas, PhD, 305-243-4518, gjf50@med.miami.edu
Guillermo Mederos, 305-243-3543, gxm1228@med.miami.edu
About this study
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
- Being tested
- Low meal condition, Moderate meal condition, High meal condition, Ad-libitum control condition
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low meal conditionOther
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 conditionOther
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 conditionOther
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 conditionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Low meal condition group | Experimental | Subjects will be in this group for up to 3 weeks. Receives: 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. Receives: 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. Receives: Other: High meal condition; Other: Ad-libitum control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: up to 3 weeks (collected during each of the intervention visits)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start13 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCI - Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, Gary Farkas, University of Miami
- Investigators
- Gary J Farkas, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103993
- Sponsor's protocol ID
- 20250335
- Status last verified
- Feb 2026
- First submitted
- 29 Jul 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Intake and Thermogenesis in High Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07103993
- Acronym / sponsor ID
- 20250335
- Conditions
- SCI - Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low meal condition group | Experimental | Other: Low meal condition, Other: Ad-libitum control conditionSubjects will be in this group for up to 3 weeks. |
| Moderate meal condition group | Experimental | Other: Moderate meal condition, Other: Ad-libitum control conditionSubjects will be in this group for up to 3 weeks. |
| High meal condition group | Experimental | Other: High meal condition, Other: Ad-libitum control conditionSubjects will be in this group for up to 3 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- SCI and Controls
- Uncompensated thyroid disease
- Diabetes
- Swallowing or gastrointestinal pathologies
- Allergies or aversions to foods/ingredients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low meal conditionParticipants 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 | Other | Low meal condition group |
| Moderate meal conditionParticipants 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. | Other | Moderate meal condition group |
| High meal conditionParticipants 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. | Other | High meal condition group |
| Ad-libitum control conditionThe 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. | Other | High meal condition group, Low meal condition group, Moderate meal condition group |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gary J Farkas, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low meal condition, Moderate meal condition and High meal condition in people with SCI - Spinal Cord Injury, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillermo Mederos ((305) 243-4518, gxm1228@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet induced thermogenesis (DIT) (time frame: up to 3 weeks (collected during each of the intervention visits)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.