Time Restricted Eating for Obesity in Spinal Cord Injury

Overseen By Michael L Kubala

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Insulin, Weight loss drugs, Corticosteroids

Disqualifiers: Pregnancy, Heart failure, Diabetes, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to test Time Restricted Eating (TRE) in Veterans with thoracic paraplegia and obesity. TRE involves eating all meals within a specific time window each day, which helps reduce calorie intake and promote weight loss. The study will assess how well these veterans can stick to this eating pattern over a period of time. The results will help design future trials to confirm TRE's effectiveness in this group. Time-restricted eating (TRE) is an emerging dietary intervention for weight loss that has shown positive effects on body weight and metabolic health in various populations.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on insulin, certain antidiabetic agents, weight loss medications, or corticosteroids, you may not be eligible to participate.

What data supports the effectiveness of the treatment Time Restricted Eating for obesity in spinal cord injury?

Research shows that time-restricted eating can lead to significant weight loss and improved health markers in individuals with conditions like multiple sclerosis, which also involves the spinal cord. Additionally, studies in animals suggest that aligning eating times with natural body rhythms can improve metabolism and reduce body weight. ^{1 2 3 4 5}

Is time-restricted eating safe for humans?

Time-restricted eating (TRE) has been studied in humans and generally shows benefits like weight loss and improved heart health markers, without major safety concerns. However, more large-scale studies are needed to confirm its safety and effectiveness. ^{1 6 7 8 9}

How is time-restricted eating different from other treatments for obesity in spinal cord injury?

Time-restricted eating (TRE) is unique because it focuses on limiting food intake to specific times of the day, aligning with natural circadian rhythms, rather than reducing calorie intake. This approach can improve metabolic health and support weight loss by enhancing the body's natural processes, which is different from traditional calorie-restricted diets. ^{1 4 7 10 11}

Research Team

Geoffrey V Henderson, MD

Principal Investigator

Syracuse VA Medical Center, Syracuse, NY

Eligibility Criteria

This trial is for Veterans aged 18-75 with spinal cord injury (SCI) and obesity, who are part of the Syracuse VA's SCI/D registry. Participants must have a BMI indicating obesity specific to SCI, eat over a 12-hour window daily, and have thoracic paraplegia. Exclusions include diabetes type 1 or significant weight loss recently, among others.

Inclusion Criteria

My spinal cord injury is classified between A to D on the ASIA scale.

Qualifying diagnosis of SCI within the SCI/D registry

I have had a spinal cord injury for more than a year.

Exclusion Criteria

I have been diagnosed with low blood pressure upon standing and am taking midodrine or fludrocortisone.

I do not have any current severe illnesses like sepsis or advanced liver failure.

I am currently taking corticosteroids.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants adhere to a time restricted eating (TRE) window for 6 weeks

6 weeks

Weekly assessments (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Time Restricted Eating

Trial Overview The study explores Time Restricted Eating (TRE), where participants consume all daily calories within a set time frame and fast outside it. This method aims to induce weight loss without calorie counting in Veterans with thoracic paraplegia due to SCI.

Participant Groups

Group I: Time Restricted Eating Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

Intermittent fasting (IF) has been shown to result in weight loss ranging from 0.8% to 13.0% of baseline weight across 27 trials, with no serious adverse events reported, indicating it is a safe option for treating obesity.

When compared to traditional calorie-restricted diets, IF produced equivalent weight loss results, and it also improved glycemic control in patients with type 2 diabetes, suggesting its potential effectiveness in managing obesity and related metabolic issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent fasting and weight loss: Systematic review. Welton, S., Minty, R., O'Driscoll, T., et al.[2021]

In a study of 85 adults with overweight or obesity, the median eating window was found to be over 14 hours, indicating prolonged eating patterns throughout the day.

Participants had significantly shorter eating windows on weekends compared to weekdays, suggesting that eating timing may vary based on daily routines, which could impact weight management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporal Eating Patterns and Eating Windows among Adults with Overweight or Obesity. Popp, CJ., Curran, M., Wang, C., et al.[2022]

Time-restricted eating (TRE) significantly reduces body weight and fat mass while preserving fat-free mass, based on a meta-analysis of 19 clinical trials.

TRE also improves important metabolic parameters, including lower blood pressure, reduced fasting glucose levels, and better cholesterol profiles, suggesting it could be an effective strategy for managing obesity and metabolic dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial Effects of Time-Restricted Eating on Metabolic Diseases: A Systemic Review and Meta-Analysis. Moon, S., Kang, J., Kim, SH., et al.[2021]

Time-restricted eating (TRE) has shown promising therapeutic effects in rodent studies, particularly in relation to body weight and metabolic health, but results in humans are inconsistent due to varying study designs and populations.

This review highlights the need for more standardized research on TRE in humans to better understand its effects and interactions with circadian biology, as well as to identify gaps in current knowledge for future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complex physiology and clinical implications of time-restricted eating. Petersen, MC., Gallop, MR., Flores Ramos, S., et al.[2023]

In a study involving adults with obesity, both 4-hour and 6-hour time-restricted feeding (TRF) regimens led to comparable weight loss of about 3% over 8 weeks, along with improvements in insulin resistance and oxidative stress.

Participants in the TRF groups reduced their daily energy intake by approximately 550 kcal without needing to count calories, suggesting that TRF can be an effective and manageable approach for weight loss and improving cardiometabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of 4- and 6-h Time-Restricted Feeding on Weight and Cardiometabolic Health: A Randomized Controlled Trial in Adults with Obesity. Cienfuegos, S., Gabel, K., Kalam, F., et al.[2022]

Time-restricted eating (TRE) is emerging as a promising strategy for treating obesity and related health issues, addressing the challenges of long-term adherence to traditional hypocaloric diets.

While TRE may help with weight loss and metabolic health through mechanisms like reduced caloric intake and improved eating behaviors, there are significant limitations in current research, including inconsistencies in clinical trials and a lack of long-term safety data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Time-restricted eating as a novel strategy for treatment of obesity and it's comorbid conditions]. Berkovskaya, MA., Gurova, OY., Khaykina, IA., et al.[2023]

Time-restricted eating (TRE) is a promising dietary strategy that can help improve metabolic health and restore circadian rhythms, potentially aiding in the prevention and treatment of obesity and its complications.

Current evidence from previous TRE trials suggests a need for more extensive clinical research, including large-scale controlled trials, to fully understand the efficacy and mechanisms of TRE in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Research progress on the application of time-restricted eating in adult obesity and related metabolic diseases]. He, JH., Sun, CY., Liang, C.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Time restricted eating facilitates weight loss and improves cardiometabolic profile in a female veteran with multiple sclerosis: A case report. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Time-Restricted Feeding Improves Glucose Tolerance in Rats, but Only When in Line With the Circadian Timing System. [2020]

3. Canada pubmed.ncbi.nlm.nih.gov

Intermittent fasting and weight loss: Systematic review. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of early vs. late time-restricted high-fat feeding on circadian metabolism and weight loss in obese mice. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Temporal Eating Patterns and Eating Windows among Adults with Overweight or Obesity. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Beneficial Effects of Time-Restricted Eating on Metabolic Diseases: A Systemic Review and Meta-Analysis. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Complex physiology and clinical implications of time-restricted eating. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of 4- and 6-h Time-Restricted Feeding on Weight and Cardiometabolic Health: A Randomized Controlled Trial in Adults with Obesity. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Time-restricted feeding of a high-fat diet in male C57BL/6 mice reduces adiposity but does not protect against increased systemic inflammation. [2019]

10. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Time-restricted eating as a novel strategy for treatment of obesity and it's comorbid conditions]. [2023]

11. China pubmed.ncbi.nlm.nih.gov

[Research progress on the application of time-restricted eating in adult obesity and related metabolic diseases]. [2022]