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

Primary Purpose

Spinal Cord Injury, Obesity

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Time Restricted Eating
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spinal Cord Injury

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Syracuse VA Medical Center, Syracuse, NY

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Time Restricted Eating

Arm Description

This is a single-arm study in a convenience sample of Veterans with thoracic 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 initially be 12 hours, then transition to 10 hours at the end of week 2, maintained through study's end (end of week 6).

Outcomes

Primary Outcome Measures

Change in the daily eating window
Measured by questionnaire (assesses the time the participant started and stopped eating each day)

Secondary Outcome Measures

Full Information

First Posted
June 7, 2023
Last Updated
October 5, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05921487
Brief Title
Time Restricted Eating to Mitigate Obesity in Veterans With Spinal Cord Injury
Official Title
Time Restricted Eating to Mitigate Obesity in Veterans With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Obesity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Intervention: This is a single-arm study in a convenience sample of Veterans with thoracic paraplegia and obesity. Research Design: Those with mean eating windows of at least 12 hours per day will be eligible to participate in the TRE intervention. Tests for adherence (food logs and time-stamped digital data) will be collected.
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Time Restricted Eating
Arm Type
Experimental
Arm Description
This is a single-arm study in a convenience sample of Veterans with thoracic 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 initially be 12 hours, then transition to 10 hours at the end of week 2, maintained through study's end (end of week 6).
Intervention Type
Behavioral
Intervention Name(s)
Time Restricted Eating
Other Intervention Name(s)
TRE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the daily eating window
Description
Measured by questionnaire (assesses the time the participant started and stopped eating each day)
Time Frame
Measured weekly from baseline to week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoffrey V Henderson, MD
Organizational Affiliation
Syracuse VA Medical Center, Syracuse, NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Syracuse VA Medical Center, Syracuse, NY
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210-2716
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
A de-identified, anonymized dataset will be created and shared upon written request for appropriate scientific reasons.
IPD Sharing Time Frame
The dataset will be available following publication of the primary manuscript for this project.
IPD Sharing Access Criteria
The dataset will be released upon written request for scientific purposes including re-analysis and validation of results.

Learn more about this trial

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

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