What side effects are associated with this type of intervention?

Common treatments for obesity include pharmacologic options like orlistat, liraglutide, and semaglutide, as well as lifestyle interventions such as time-restricted eating (TRE) and caloric restriction. Orlistat often causes gastrointestinal side effects like intestinal discomfort and increased bowel movements. Liraglutide and semaglutide, both GLP-1 receptor agonists, can lead to gastrointestinal issues such as nausea and vomiting. TRE and caloric restriction are generally well-tolerated but may cause initial hunger and irritability as the body adjusts to new eating patterns.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, including semaglutide and liraglutide, which are glucagon-like peptide-1 (GLP-1) receptor agonists. These medications have shown significant weight loss benefits in clinical trials. While these drugs do not directly align with the concept of Time Restricted Eating (TRE), they are part of a broader strategy to manage obesity through pharmacotherapy. TRE focuses on limiting the eating window to improve metabolic health, which is a different approach compared to pharmacological interventions.

What other types of research exist?

Promising novel alternatives to Time Restricted Eating for obesity patients include: 1) Metreleptin treatment, which improves satiety and reduces hunger in lipodystrophy patients; 2) Liraglutide, a glucagon-like peptide-1 analogue, which has been shown to reduce food intake, modify appetite sensations, and improve eating behaviors in various populations; 3) Portion-controlled meals, which simplify meal planning and promote accurate self-monitoring of calorie intake. These alternatives have demonstrated effectiveness in clinical studies and could be considered for obesity treatment in 2024.

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Behavioral Intervention

Time Restricted Eating for Obesity in Spinal Cord Injury

N/A

Waitlist Available

Led By Geoffrey V Henderson, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured weekly from baseline to week 6

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects of TRE may include hunger pangs, fatigue during fasting periods, irritability or mood changes initially as the body adapts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured weekly from baseline to week 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured weekly from baseline to week 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured weekly from baseline to week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the daily eating window

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Time Restricted EatingExperimental Treatment1 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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Time Restricted Eating

2018

N/A

~50

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity include dietary interventions, pharmacotherapy, and behavioral modifications. Dietary interventions like Time Restricted Eating (TRE) limit the eating window, which helps reduce overall caloric intake and improve metabolic health by aligning eating patterns with circadian rhythms. Pharmacotherapy often targets appetite suppression or metabolic rate enhancement to reduce caloric intake or increase energy expenditure. Behavioral modifications focus on changing eating habits and increasing physical activity. These mechanisms are crucial for obesity patients as they address the root causes of weight gain and metabolic dysfunction, leading to sustainable weight loss and improved overall health.

Is there a path for approval of an antiobesity drug: what did the Sibutramine Cardiovascular Outcomes Trial find?Pharmacotherapy of obesity: emerging drugs and targets.