Spinal Cord InjuryNCT05921487
Time Restricted Eating to Mitigate Obesity in Veterans With Spinal Cord Injury
A study testing Time Restricted Eating in people with Spinal Cord Injury and Obesity, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Spinal cord injury (SCI) causes paralysis and muscle atrophy and leads to weight gain and obesity. Obesity directly contributes to functional impairment and cardiometabolic dysfunction. There is a critical need to reduce the growing prevalence of obesity and cardiometabolic disease after SCI. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Spinal Cord Injury, Obesity
- What is being tested?
- Time Restricted Eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 10 Aug 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran
- A member of the Spinal Cord Injury/Disorder (SCI/D) registry through the Syracuse VA, including both hub and spoke sites
- A qualifying diagnosis of SCI within the SCI/D registry
- Neurologic level of injury from T1 to S5, based on most recent Status Update or American Spinal Injury Association Impairment Scale (ASIA) examination, or a diagnosis of a hereditary form of paraplegia (such as familial spastic paraplegia or hereditary spastic paraplegia)
- ASIA Impairment Scale grade A-D
- Chronic SCI (> 1 year from date of SCI or diagnosis of SCI)
- BMI > 22 - the BMI used to diagnose obesity in individuals with SCI
- Mean eating window of at least 10 hours per day
Who cannot join
- Females who are pregnant (tested via urinary human chorionic gonadotropin (hCG)), planning to become pregnant in the next 6 months, or breast-feeding
- A member of the SCI/D registry through the Syracuse VA, with a qualifying diagnosis of MS or ALS
- Diagnosis of heart failure
- Diagnosis of diabetes mellitus, type 1
- Diagnosis of diabetes mellitus, type 2, and on insulin or other antidiabetic agent with high incidence of hypoglycemia
- o Of note, antidiabetic agents with low incidence of hypoglycemia are: metformin, Glucagon-like peptide-1 (GLP-1) receptor agonists, Sodium-glucose cotransporter-2 (SGLT2) inhibitors, Dipeptidyl peptidase 4 (DPP-4) inhibitors, alpha glucosidase inhibitors, thiazolidinediones (as discussed with VA pharmacist)
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- Diagnosis of End Stage Renal Disease
- Diagnosis of dementia
- Diagnosis of orthostatic hypotension and prescribed midodrine or fludrocortisone
- History of syncopal episode in the month prior to the study
- History of significant weight loss (> 10% body weight) in the month prior to the study
- History of eating disorders (e.g., anorexia or bulimia) within the last five years, or clearance from a mental health provider
- History of active suicidal ideation in the last six months, or clearance from a mental health provider
- Currently prescribed weight loss medication (e.g., liraglutide)
- Currently prescribed corticosteroids
- Current acute medical issues including cancer, sepsis, advanced liver failure, porphyria, or uncontrolled hyperthyroidism
Trial locations and contacts
1 site in 1 country.
United States1 site
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, 13210-2716
About this study
Spinal cord injury (SCI) causes paralysis and muscle atrophy and leads to weight gain and obesity. Obesity directly contributes to functional impairment and cardiometabolic dysfunction. There is a critical need to reduce the growing prevalence of obesity and cardiometabolic disease after SCI. My overall objective in this project is to gather crucial feasibility data on time restricted eating (TRE), a novel form of intermittent fasting. TRE is a straightforward method to induce weight loss without the need for calorie counting. TRE allows individuals to eat all their daily calories in a time restricted window and fast outside that window. A growing body of literature supports the safety and efficacy of TRE. Given the feasibility, high adherence, and substantial benefits of TRE in able-bodied individuals, it is important to test TRE to determine its feasibility in Veterans with SCI. The investigators will first test this intervention in Veterans with paraplegia, who are at greatest risk of muscle-joint upper body injury given the need to support body weight during activity. The investigators will determine adherence to a TRE window for 6-weeks duration in a convenience sample of Veterans with paraplegia and obesity. Based on the expected outcomes of good adherence, this study will lay the groundwork for future work by informing the design of a randomized controlled trial to test the efficacy of TRE to facilitate weight loss and improve function.
- Conditions
- Spinal Cord Injury, Obesity
- Being tested
- Time Restricted Eating
- Medical subject headings
- Spinal Cord Injuries, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restricted EatingBehavioural
Also called TRE
Time Restricted Eating Protocol: Subjects will be instructed to limit caloric consumption to a 10-hour TRE window. The window start-time will be self-selected (individualized). During the eating window, subjects will not be restricted on types or quantities of food consumed, and will be advised to continue their usual diets. Subjects will not be required to monitor their caloric intake. During the fasting period, subjects will be encouraged to stay hydrated and drink ample water. Outside the designated eating window, subjects are only permitted to consume medication, water, or zero-calorie herbal drinks such as unsweetened tea or black coffee.
| Study group | Role | What they receive |
|---|---|---|
| Time Restricted Eating | Experimental | This is a single-arm study in a convenience sample of Veterans with paraplegia and obesity. The intervention will test adherence of participants to a TRE window with a self-selected start time. The duration of the eating window will be 10 hours, maintained through study's end (end of week 6). Receives: Behavioral: Time Restricted Eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the daily eating window
Measured by questionnaire (assesses the time the participant started and stopped eating each day)
Measured: Measured weekly from baseline to week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 Sep 2023
- Primary completion1 Jul 2026
- Study completion10 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention: This is a single-arm study in a convenience sample of Veterans with paraplegia and obesity. Research Design: Those with mean eating windows of at least 10 hours per day will be eligible to participate in the TRE intervention. Tests for adherence (food log) will be collected.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Geoffrey V Henderson, MD, Principal investigator, Syracuse VA Medical Center, Syracuse, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921487
- Sponsor's protocol ID
- B4538-M
- Other IDs
- 1IK1RX004538-01A1
- Status last verified
- Aug 2026
- First submitted
- 7 Jun 2023
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified, anonymized dataset will be created and shared upon written request for appropriate scientific reasons.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Restricted Eating to Mitigate Obesity in Veterans With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05921487
- Acronym / sponsor ID
- B4538-M
- Conditions
- Spinal Cord Injury, Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 10 Aug 2027 (estimated)
- First posted
- 27 Jun 2023 (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.
Spinal cord injury (SCI) causes paralysis and muscle atrophy and leads to weight gain and obesity. Obesity directly contributes to functional impairment and cardiometabolic dysfunction. There is a critical need to reduce the growing prevalence of obesity and cardiometabolic disease after SCI. My overall objective in this project is to gather crucial feasibility data on time restricted eating (TRE), a novel form of intermittent fasting. TRE is a straightforward method to induce weight loss without the need for calorie counting. TRE allows individuals to eat all their daily calories in a time restricted window and fast outside that window. A growing body of literature supports the safety and efficacy of TRE. Given the feasibility, high adherence, and substantial benefits of TRE in able-bodied individuals, it is important to test TRE to determine its feasibility in Veterans with SCI. The investigators will first test this intervention in Veterans with paraplegia, who are at greatest risk of muscle-joint upper body injury given the need to support body weight during activity. The investigators will determine adherence to a TRE window for 6-weeks duration in a convenience sample of Veterans with paraplegia and obesity. Based on the expected outcomes of good adherence, this study will lay the groundwork for future work by informing the design of a randomized controlled trial to test the efficacy of TRE to facilitate weight loss and improve function.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention: This is a single-arm study in a convenience sample of Veterans with paraplegia and obesity. Research Design: Those with mean eating windows of at least 10 hours per day will be eligible to participate in the TRE intervention. Tests for adherence (food log) will be collected.
| Arm | Type | Receives |
|---|---|---|
| Time Restricted Eating | Experimental | Behavioral: Time Restricted EatingThis is a single-arm study in a convenience sample of Veterans with paraplegia and obesity. The intervention will test adherence of participants to a TRE window with a self-selected start time. The duration of the eating window will be 10 hours, maintained through study's end (end of week 6). |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Veteran
- A member of the Spinal Cord Injury/Disorder (SCI/D) registry through the Syracuse VA, including both hub and spoke sites
- A qualifying diagnosis of SCI within the SCI/D registry
- Neurologic level of injury from T1 to S5, based on most recent Status Update or American Spinal Injury Association Impairment Scale (ASIA) examination, or a diagnosis of a hereditary form of paraplegia (such as familial spastic paraplegia or hereditary spastic paraplegia)
- ASIA Impairment Scale grade A-D
Key exclusion criteria (16 listed)
- Females who are pregnant (tested via urinary human chorionic gonadotropin (hCG)), planning to become pregnant in the next 6 months, or breast-feeding
- A member of the SCI/D registry through the Syracuse VA, with a qualifying diagnosis of MS or ALS
- Diagnosis of heart failure
- Diagnosis of diabetes mellitus, type 1
- Diagnosis of diabetes mellitus, type 2, and on insulin or other antidiabetic agent with high incidence of hypoglycemia
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 |
|---|---|---|
| Time Restricted EatingAlso: TRETime Restricted Eating Protocol: Subjects will be instructed to limit caloric consumption to a 10-hour TRE window. The window start-time will be self-selected (individualized). During the eating window, subjects will not be restricted on types or quantities of food consumed, and will be advised to continue their usual diets. Subjects will not be required to monitor their caloric intake. During the fasting period, subjects will be encouraged to stay hydrated and drink ample water. Outside the designated eating window, subjects are only permitted to consume medication, water, or zero-calorie herbal drinks such as unsweetened tea or black coffee. | Behavioural | Time Restricted Eating |
Primary outcome
Change in the daily eating window
Time frame: Measured weekly from baseline to week 6
Measured by questionnaire (assesses the time the participant started and stopped eating each day)
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 2 Sep 2026.
- Individual participant dataSharing planned: Yes. A de-identified, anonymized dataset will be created and shared upon written request for appropriate scientific reasons.
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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. This study is not recruiting at the moment.
Geoffrey V Henderson, MD principal investigator
Syracuse VA Medical Center, Syracuse, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time Restricted Eating in people with Spinal Cord Injury and Obesity, run by VA Office of Research and Development 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 16 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: under way, not looking for participants, as of the sponsor's last update on 2 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the daily eating window (time frame: Measured weekly from baseline to week 6). 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 2 Sep 2026.