Time-Restricted Eating vs Traditional Dieting for Obesity

(NY-TREAT Trial)

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

62 Participants Needed

Trial Summary

What is the purpose of this trial?

Over half of American adults have overweight or obesity and are at high risk of developing type 2 diabetes and cardiovascular diseases. Although caloric restriction has many health benefits, it is difficult to sustain overtime for most people. Time restricted eating (TRE), a novel type of intermittent fasting, facilitates adherence to the intervention and results in weight loss and improvement of metabolism. The investigators propose to examine the efficacy of self-monitoring and TRE (10-h/d) vs. self-monitoring and habitual prolonged eating duration (HABIT) (13 hours/d) on weight loss and body composition, metabolic function and circadian biology, in metabolically unhealthy adults aged 50 to 75 y old, with overweight or obesity. The investigators hypothesize that TRE, compared to habitual long duration of eating, will decrease cardiovascular risk burden.

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.

What data supports the effectiveness of the treatment HABIT, Habitual Prolonged Eating Duration, Standard 3-Meals-Per-Day Diet, TRE, Time Restricted Eating, Intermittent Fasting, TRE for obesity?

Research suggests that time-restricted eating (TRE), a form of intermittent fasting, can help improve metabolic health and aid in weight loss for individuals with obesity. Studies indicate that TRE may enhance circadian rhythms and improve body weight and fasting glucose levels, making it a promising strategy for managing obesity and related metabolic conditions. ^{1 2 3 4 5}

Is time-restricted eating safe for humans?

Time-restricted eating (TRE) appears to be generally safe for humans, with studies showing it can lead to mild weight loss and improvements in some aspects of heart and metabolic health, such as lowering blood pressure and improving insulin resistance. ^{4 6 7 8 9}

How does the treatment of time-restricted eating differ from traditional dieting for obesity?

Time-restricted eating (TRE) is unique because it focuses on limiting the hours during which food is consumed each day, rather than restricting specific foods or calories. This approach is thought to enhance the body's natural fasting state, potentially improving metabolism and weight loss, unlike traditional diets that often focus on calorie counting or specific food restrictions. ^{2 3 5 7 10}

Research Team

Blandine Laferrère, M.D., Ph.D.

Principal Investigator

Columbia University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. Australia 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. [2022]

2. England 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. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Design and Implementation of a Time-Restricted Eating Intervention in a Randomized, Controlled Eating Study. [2023]

4. China pubmed.ncbi.nlm.nih.gov

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

5. United States 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. [2023]

6. 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]

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

Time restricted eating as a weight loss intervention in adults with obesity. [2021]

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

Implementation of weekday time-restricted eating to improve metabolic health in breast cancer survivors with overweight/obesity. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Current research: effect of time restricted eating on weight and cardiometabolic health. [2022]

10. Switzerland 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. [2021]