Time Restricted Eating for Weight Loss Maintenance

(TWIST Trial)

Overseen By Collin Popp

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Appetite suppressants, Anti-obesity medications

Disqualifiers: Pregnancy, Bariatric surgery, Eating disorder, Diabetes, others

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

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two different time-restricted eating (TRE) schedules can help people maintain weight they have already lost. Participants will eat within either a 6-hour or a 10-hour window each day. The study seeks individuals who have recently lost at least 5% of their body weight without surgery and typically eat over more than 12 hours a day. As an unphased trial, it offers a unique opportunity to contribute to innovative research on weight maintenance strategies.

Do I need to stop taking my current medications for the trial?

You may need to stop certain medications to join the trial. If you are on appetite suppressants, anti-obesity medications, or medications expected to cause weight loss, you might need to delay treatment with these for the next 3 months.

What prior data suggests that this time-restricted eating method is safe for weight loss maintenance?

Research has shown that time-restricted eating (TRE) is generally safe for people. Studies have found that eating within a set number of hours each day, such as 6 or 10 hours, does not negatively affect diet quality. In fact, these eating patterns can aid in weight loss and promote a healthier body. For instance, one study found that eating within a 10-hour window helped participants lose weight, lower blood pressure, and reduce harmful blood fats, which can lead to heart problems.

Short-term studies also indicate that TRE is safe and easy for healthy adults to follow. Participants in these studies did not experience any serious side effects. Instead, they benefited from weight loss and reduced body fat over time. This suggests that TRE can be a safe option for those aiming to maintain weight loss. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about time-restricted eating (TRE) for weight loss maintenance because it offers a fresh approach compared to traditional calorie counting or dietary restrictions. TRE allows individuals to eat freely within a specific time window, like 10 hours (TRE10) or even just 6 hours (TRE6), which can be more manageable and sustainable for many people. Unlike typical diets that require constant monitoring of food intake, TRE focuses on when you eat rather than what or how much, potentially making it easier to maintain long-term. This method could simplify weight management by aligning eating patterns with the body's natural circadian rhythms, which might enhance metabolism and promote better overall health.

What evidence suggests that this trial's time-restricted eating interventions could be effective for weight loss maintenance?

Research has shown that time-restricted eating (TRE) can help people maintain weight loss. Studies have found that TRE can lead to modest weight loss, with some individuals losing and keeping off 5-10% of their body weight over a year. In this trial, participants will follow different TRE schedules: one group will eat within a 10-hour window, which earlier studies showed can lead to a 3% weight loss after 12 weeks, while another group will eat within a 6-hour window. TRE has also reduced waist size and improved body mass index, a measure of body fat based on height and weight. Overall, TRE aids in weight management by helping people eat fewer calories and improving health indicators. ^{4 6 7 8 9}

Who Is on the Research Team?

Mary A. Sevick, ScD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults aged 25-65 with a BMI of 20.5-45 who have lost at least 5% of their body weight without surgery, are not very physically active, and typically eat over a span of more than 12 hours daily. Excluded are those over 400lbs, pregnant or breastfeeding women, anyone with eating disorders or certain medical conditions like active cancer or severe diabetes.

Inclusion Criteria

BMI between 20.5 - 45 m/kg2

Eating window >12 h per day

<150 mins/wk of physical activity

Exclusion Criteria

My body weight is over 400lbs (181.4kg).

I am either younger than 25 or older than 65.

Pregnant, trying to get pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Initial measurements and randomization into TRE6 or TRE10 groups

1 week

1 visit (in-person)

Treatment

Participants follow their assigned time-restricted eating schedule (TRE6 or TRE10)

12 weeks

3 visits (in-person) at baseline, 4 weeks, and 12 weeks

Follow-up

Participants are monitored for weight maintenance and adherence to TRE

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Time Restricted Eating (TRE)

Trial Overview The study tests two time-restricted eating plans for maintaining weight loss: one group eats within a 6-hour window (TRE6), the other within a 10-hour window (TRE10). Participants will be randomly assigned to these groups and monitored over a period of up to three months.

How Is the Trial Designed?

Group I: Time-Restricted Eating - 6 Hours (TRE6) Experimental Treatment 1 Intervention

Participants will be instructed to consume all daily food and beverages during their allotted 6-hour time period.

Group II: Time-Restricted Eating - 10 Hours (TRE10) Experimental Treatment 1 Intervention

Participants will be instructed to consume all daily food and beverages during their allotted 10-hour time period.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6836017/

Effectiveness of Intermittent Fasting and Time-Restricted ... On average, this approach produces modest weight loss (5–10% sustained for ≥1 year) [4]. The magnitude of weight loss with CER is minimally ...

2. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2794819

Effectiveness of Early Time-Restricted Eating for Weight ... In this randomized clinical trial, eTRE was more effective for losing weight and improving diastolic blood pressure and mood than eating over a window of 12 or ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9407646/

Effects of four-hour and six-hour time-restricted feeding on ... Most recently, another single-arm trial of 10-h TRF demonstrated 3.0% weight loss and an 8% reduction in caloric intake after 12 weeks in participants with ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2589004224002219

Time-restricted eating improves health because of energy ... The results showed that TRE led to modest weight loss, lower waist circumference and energy deficits. TRE also improved body mass index, fat ...

5. bmj.com bmj.com/content/389/bmj-2024-082007

Intermittent fasting strategies and their effects on body ... The current evidence provides some indication that intermittent fasting diets have similar benefits to continuous energy restriction for weight loss and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6953486/

Ten-hour time-restricted eating reduces weight, blood ... Time-restricted eating led to weight loss, healthier body composition, lower blood pressure, and decreased levels of cardiovascular disease-promoting lipids.

7. hopkinsmedicine.org hopkinsmedicine.org/health/wellness-and-prevention/intermittent-fasting-what-is-it-and-how-does-it-work

Intermittent Fasting: What is it, and how does it work? Intermittent fasting involves switching between fasting and eating on a regular schedule. This type of fasting could manage your weight or even some forms ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1550413123004540

Time-restricted eating: Watching the clock to treat obesity These preliminary studies show that limiting the eating window to 4–10 h per day does not negatively impact diet quality, but more research is ...

9. nejm.org nejm.org/doi/full/10.1056/NEJMoa2114833

Calorie Restriction with or without Time-Restricted Eating ... Several pilot clinical studies showed that time-restricted eating resulted in reduction over time in the body weight and fat mass in patients ...