An interventional study of Time Restricted Eating in Spinal Cord Injury and Obesity, sponsored by VA Office of Research and Development. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Other
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 15 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
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).
Behavioral: Time Restricted Eating
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.
Also known as: TRE
Change in the daily eating window
Measured by questionnaire (assesses the time the participant started and stopped eating each day)
Time frame: Measured weekly from baseline to week 6
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — A de-identified, anonymized dataset will be created and shared upon written request for appropriate scientific reasons.
Supporting information: Sap
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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VA Office of Research and Development