NCT05921487Active, not recruiting
Time Restricted Eating to Mitigate Obesity in Veterans With Spinal Cord Injury
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 7 Jun 2023
- Start date
- 1 Sept 2023
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Obesity
- NCT number
- NCT05921487
What you commit to
- Study type: Interventional
- Participants enrolled: 15
- From 1 Sept 2023 to the primary completion date, 1 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Currently prescribed weight loss medication (e.g., liraglutide)
- Currently prescribed corticosteroids
Other illness
- Diagnosis of heart failure
- Diagnosis of diabetes mellitus, type 1
- Diagnosis of End Stage Renal Disease
- Diagnosis of dementia
- Current acute medical issues including cancer, sepsis, advanced liver failure, porphyria, or uncontrolled hyperthyroidism
Lab values
- 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)
- 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
Other
- 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 orthostatic hypotension and prescribed midodrine or fludrocortisone
Who the study is looking for
- 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
Age in the registry: 18 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Syracuse VA Medical Center, Syracuse, NY Coordinator of this site? Confirm its status | Syracuse | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.