Time-Restricted Eating vs Traditional Dieting for Obesity

(NY-TREAT Trial)

Not currently recruiting at 1 trial location

Overseen By Rabiah Borhan, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must not be taking: Weight loss drugs, Sleep aids

Disqualifiers: Sleep disorders, Organ dysfunction, Seizure history, others

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

Compensation: Varies

Number of Visits: 12

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two different eating approaches to aid weight loss and improve metabolism in people with obesity. One group will follow time-restricted eating (TRE), consuming all meals within a 10-hour window each day. The other group will maintain their usual eating schedule, spread over 13 hours or more, known as Habitual Prolonged Eating Duration (HABIT). The researchers aim to determine if TRE can reduce the risk of heart problems compared to traditional eating patterns. Individuals aged 50 to 75 with obesity and conditions like prediabetes or diet-controlled type 2 diabetes may be suitable candidates.

As an unphased trial, this study provides a unique opportunity to contribute to understanding how different eating patterns can impact health and potentially improve quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it excludes those using medications that affect sleep, circadian rhythms, or metabolic function, so you may need to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that time-restricted eating (TRE) can aid in weight loss and improve insulin levels. This method involves eating only during a specific number of hours each day. Some studies have found that TRE can help individuals lose 3%–5% of their body weight within a few months. However, some participants might experience minor issues such as nausea, headaches, or changes in sleep patterns.

Overall, TRE appears to be well-tolerated, but individual responses can vary. Prospective participants should consult their doctor about any concerns before joining a study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different approaches to eating schedules for addressing obesity. Traditional dieting often focuses on counting calories or specific food restrictions, but the TRE (Time-Restricted Eating) method is unique because it limits the time window for eating to 10 hours or less each day. This method might help regulate metabolism and improve weight management without requiring participants to change what they eat, just when they eat. The HABIT group, meanwhile, maintains a typical eating schedule, which allows researchers to compare the effects of time-restricted eating against a more conventional approach. This trial could reveal new insights into how timing, rather than just diet content, impacts obesity.

What evidence suggests that this trial's treatments could be effective for obesity?

This trial will compare Time-Restricted Eating (TRE) with a Habitual Prolonged Eating Duration (HABIT) approach. Studies have shown that TRE can aid in weight loss and improve health. Research indicates that individuals using TRE can lose about 3% to 5% of their body weight over a few months. TRE has also been linked to lower fasting insulin levels and enhanced fat burning. Participants in TRE programs often experience improvements in blood pressure and mood. These findings suggest that TRE might help reduce the risk of diseases like type 2 diabetes and heart disease by supporting weight loss and better metabolic health. ^{1 3 6 7 8}

Who Is on the Research Team?

Blandine Laferrère, M.D., Ph.D.

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 50-75 in the NYC area, with a BMI of 25-45 and conditions like hypertension, prediabetes or type 2 diabetes controlled by diet/metformin. Participants should have stable weight, eat breakfast habitually, and own a smartphone. Exclusions include smokers, those with severe diseases or sleep disorders, previous bariatric surgery patients, heavy alcohol consumers, and certain medication users.

Inclusion Criteria

In possession of a smart phone (iPhone or Android)

I have been diagnosed with dyslipidemia and am on a stable treatment plan.

I have prediabetes or Type 2 Diabetes managed with diet or metformin.

Exclusion Criteria

You have a history of serious eating or mental health problems.

I have a diagnosed sleep disorder or severe insomnia.

I do not have severe lung, kidney, or heart disease, and I am not currently ill.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either a time restricted eating (TRE) window of 10 hours or a habitual eating window of 13 hours, with self-monitoring via a smartphone application

12 months

Ambulatory assessments at 0, 3, and 12 months

Follow-up

Participants are monitored for changes in body weight, fat mass, insulin resistance, and other metabolic markers

4 weeks

Final assessment at 12 months

What Are the Treatments Tested in This Trial?

Interventions

• HABIT
• TRE

Trial Overview

The study compares two eating patterns to improve heart health and metabolism in overweight individuals: Time Restricted Eating (TRE) where participants eat within a 10-hour window versus their usual pattern (HABIT) of eating over a span of about 13 hours daily. The focus is on whether TRE can better reduce cardiovascular risks.

How Is the Trial Designed?

Group I: TRE Group Experimental Treatment 1 Intervention

Participants randomized to TRE will reduce their eating window to a self-selected eating window (≤10-h).

Group II: HABIT Group Active Control 1 Intervention

Participants randomized to the HABIT group will maintain their habitual eating schedule (≥13-h).

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

New York University

Collaborator

Trials

249

Recruited

229,000+

Salk Institute for Biological Studies

Collaborator

Trials

23

Recruited

2,200+

Published Research Related to This Trial

A time-restricted eating (TRE) intervention designed for people with type 2 diabetes and overweight includes a two-phase approach: an initial strict phase followed by a more flexible phase tailored to individual needs.

Support from healthcare professionals, family, and peers is crucial for maintaining motivation and adherence to the TRE regimen, emphasizing a whole-person approach that considers participants' past experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing a Co-created Intervention to Promote Motivation and Maintenance of Time-Restricted Eating in Individuals With Overweight and Type 2 Diabetes. Hempler, NF., Bjerre, N., Varming, AR., et al.[2023]

In an 8-week pilot study involving 78 participants with obesity, those following a 14-hour time-restricted eating (TRE) schedule lost an average of 8.5% of their body weight, which was statistically significant compared to a 12-hour TRE group that lost 7.1%.

The 14:10 TRE group also experienced a significant reduction in fasting blood glucose levels by 7.6 mg/dl, indicating potential metabolic benefits, especially for those with elevated blood glucose at baseline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of time restricted eating on body weight and fasting glucose in participants with obesity: results of a randomized, controlled, virtual clinical trial. Peeke, PM., Greenway, FL., Billes, SK., et al.[2021]

In a study of 50 adults with overweight and obesity, participants successfully reduced their eating window from an average of 16 hours to about 12 hours over a 90-day time-restricted eating (TRE) intervention, leading to significant weight loss and reductions in waist circumference and blood pressure.

The TRE approach, which required no dietary counseling and was monitored through a smartphone app, showed a feasible and effective way to improve eating patterns and health outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Smartphone Intervention to Promote Time Restricted Eating Reduces Body Weight and Blood Pressure in Adults with Overweight and Obesity: A Pilot Study. Prasad, M., Fine, K., Gee, A., et al.[2021]

The study demonstrated that an 8-week telephone-based weekday-only time-restricted eating (TRE) intervention was feasible and well-accepted among 22 breast cancer survivors aged 60 and older, with a high adherence rate of 98%.

Despite the successful implementation, there were no significant changes in metabolic syndrome components or lipid profiles, suggesting that longer intervention durations may be needed to achieve consistent metabolic improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of weekday time-restricted eating to improve metabolic health in breast cancer survivors with overweight/obesity. Kirkham, AA., Ford, KL., Ramos Da Silva, B., et al.[2023]

This study is the first to evaluate the effects of time-restricted eating (TRE) on weight loss in a controlled manner, comparing it to a usual eating pattern (UEP) while ensuring both groups consumed the same number of calories and identical diets.

Participants aged 21-69 with prediabetes and obesity were monitored closely, allowing for a rigorous assessment of how meal timing impacts weight change without altering caloric intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Implementation of a Time-Restricted Eating Intervention in a Randomized, Controlled Eating Study. White, K., Wu, B., Pilla, SJ., et al.[2023]

Intermittent fasting (IF) may be an effective weight management strategy for overweight and obese adults, but its evidence base in humans is still limited, with only one published systematic review available.

Current guidelines from the National Institute for Health and Care Excellence (NICE) do not recommend very low calorie diets (VLCD) as a routine treatment for obesity, highlighting concerns about potential side effects and the sustainability of fasting approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent fasting interventions for the treatment of overweight and obesity in adults aged 18 years and over: a systematic review protocol. Jane, L., Atkinson, G., Jaime, V., et al.[2022]

Time-restricted eating (TRE) can lead to a spontaneous reduction in energy intake by 20-30%, resulting in a small but significant weight loss of 1-4% in human subjects.

TRE may also improve cardiometabolic health by significantly lowering both systolic and diastolic blood pressure, as well as enhancing fasting insulin levels and reducing insulin resistance, independent of weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current research: effect of time restricted eating on weight and cardiometabolic health. Gabel, K., Varady, KA.[2022]

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]

In a pilot study of 50 participants with obesity over 12 weeks, time-restricted eating (TRE) led to a modest average weight loss of 2.6 kg, with greater weight loss observed in those who adhered to the regimen at least five days a week.

While TRE showed similar weight loss results compared to more complex weight management methods, it did not significantly impact blood pressure or lipid profiles, suggesting its primary benefit may be in weight management rather than metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time restricted eating as a weight loss intervention in adults with obesity. Przulj, D., Ladmore, D., Smith, KM., et al.[2021]

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]

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