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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether time-restricted eating (TRE) can aid weight loss in Veterans with spinal cord injuries (SCI) who also face obesity. TRE, a form of intermittent fasting, involves consuming all daily calories within a specific time window, simplifying weight management without calorie counting. The trial will assess if participants with paraplegia can adhere to a 10-hour eating window for six weeks. The study seeks Veterans with paraplegia from the Syracuse VA registry who have lived with SCI for over a year and have a BMI over 22. As an unphased trial, it offers Veterans a unique opportunity to explore innovative weight management strategies tailored to their specific needs.

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 prior data suggests that time restricted eating is safe for individuals with spinal cord injury?

Research has shown that time-restricted eating (TRE) is generally safe. Studies have found that TRE can aid weight loss and improve heart health without major safety concerns. Many find it easy to follow, which is a significant advantage.

TRE involves consuming all meals within a specific daily window, usually between 6 to 11 hours. This method has been linked to better overall health, such as correcting disrupted body rhythms often seen in overweight individuals.

Overall, most people tolerate TRE well. Studies have not reported any serious side effects, making it a promising option for managing weight and improving health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Time Restricted Eating (TRE) is unique because it offers a non-pharmacological approach to managing obesity in individuals with spinal cord injury. Unlike traditional treatments that often involve medication or surgery, TRE focuses on when you eat rather than what you eat, allowing participants to choose their own 10-hour eating window. Researchers are excited about TRE because it could improve adherence by giving individuals more flexibility and control over their eating habits, potentially leading to better long-term weight management and overall health.

What evidence suggests that time restricted eating is effective for obesity in spinal cord injury?

Research has shown that time-restricted eating (TRE) can aid weight loss and improve heart health. Studies have found that people using TRE can lose weight without counting calories. TRE involves consuming all daily food within a limited time, such as 8-10 hours, and fasting for the remainder. One study found that mice on a high-fat diet did not gain weight when they ate within a set time frame and also showed health improvements. Other research in humans has demonstrated benefits like reduced body fat and improved heart health indicators. This trial will specifically test adherence to a 10-hour TRE window in Veterans with paraplegia and obesity, suggesting that TRE could be a promising approach to addressing obesity, even for those with spinal cord injuries. ^{1 2 6 7 8}

Who Is on the Research Team?

Geoffrey V Henderson, MD

Principal Investigator

Syracuse VA Medical Center, Syracuse, NY

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10114984/

Time restricted eating facilitates weight loss and improves ... TRE – a form of intermittent fasting – is a dietary strategy that has been shown to facilitate weight loss, improve cardiometabolic indices, and ...

2. withpower.com withpower.com/trial/phase-spinal-cord-injuries-8-2023-b5b38

Time Restricted Eating for Obesity in Spinal Cord Injury Time-restricted eating (TRE) has been studied in humans and generally shows benefits like weight loss and improved heart health markers, without major safety ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10111287/

Time-restricted eating: What we know and where the field is ... This study demonstrated that, when mice on a high-fat diet ate within an 8-hour window, they did not gain weight and they had many health improvements compared ...

4. mdpi.com mdpi.com/2072-6643/16/19/3390

The Effects of Time-Restricted Eating on Fat Loss in Adults ... Subgroup analyses showed that TRE only or TRE-caloric restriction with an eating window of 6 to 8 h may be appropriate for losing body fat and overall weight.

5. mdpi.com mdpi.com/2072-6643/11/10/2442

Effectiveness of Intermittent Fasting and Time-Restricted ... The available evidence suggests that IER paradigms produce equivalent weight loss when compared to CER, with 9 out of 11 studies reviewed showing no ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2666379123005803

Article Early time-restricted eating improves markers of ... The eTRE schedule is more effective than the control eating schedule for improving markers of cardiometabolic health, including 24-h mean ...

7. journals.physiology.org journals.physiology.org/doi/abs/10.1152/physrev.00006.2022

Complex physiology and clinical implications of time- ... Time-restricted eating (TRE) is a dietary intervention that limits food consumption to a specific time window each day. The effect of TRE on body weight and ...

8. mdpi.com mdpi.com/2072-6643/12/5/1267

Beneficial Effects of Time-Restricted Eating on Metabolic ... TRE reduces body weight and improves metabolic dysfunction by repairing the disrupted circadian rhythm in people who are overweight and obese [50,52]. TRE is a ...