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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05921487
• Other study ID #: B4538-M
• Secondary ID: 1IK1RX004538-01A
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: October 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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 thoracic 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 thoracic 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: August 31, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Veteran, age 18 to 75 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 75 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 T12, based on most recent Status Update or ASIA examination

• 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 12 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

Related Conditions & MeSH terms

• Obesity
• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Behavioral:
• Time Restricted Eating
Time Restricted Eating Protocol: Subjects will be instructed to limit caloric consumption to a 12-hour TRE window for the first two weeks of the study, and then transition 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.

Locations

Country	Name	City	State
United States	Syracuse VA Medical Center, Syracuse, NY	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the daily eating window	Measured by questionnaire (assesses the time the participant started and stopped eating each day)	Measured weekly from baseline to week 6