Time Restricted Eating to Mitigate Obesity in Veterans With Spinal Cord Injury

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.

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Key information

Conditions

Spinal Cord Injury Body Weight Central Nervous System Diseases Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210-2716, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Veteran, age 18 to 89 years old
The Syracuse SCI registry includes adults only, so the youngest age of enrollment is 18. The effects of fasting on age-induced sarcopenia remain "uncertain"; therefore, the investigators will cap the age at 89 years old
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 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

Exclusion criteria

Females who are pregnant (tested via urinary 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, GLP-1 receptor agonists, SGLT2 inhibitors, DPP4 inhibitors, alpha glucosidase inhibitors, thiazolidinediones (as discussed with VA pharmacist)

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

Treatment and study plan

Time restricted eating

Behavioral

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.

Other names: TRE

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Jun 27, 2023
Registry last updated: Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed