Time-Restricted Eating for Weight Loss Maintenance

(TWIST-2 Trial)

Overseen By Margaret Curran

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Appetite suppressants, Weight-affecting drugs

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 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether time-restricted eating (TRE), where eating occurs within a 10-hour window each day, can help maintain weight loss and prevent fat gain. Researchers are also examining how TRE affects hunger after meals. Participants will either follow the TRE method or receive standard advice on maintaining weight. Ideal candidates have lost at least 5% of their body weight in the last three months, have a current BMI between 20.5 and 45, and are open to using a smartphone for tracking. As an unphased trial, this study offers participants the opportunity to contribute to innovative research on weight management strategies.

Will I have to stop taking my current medications?

The trial requires that participants not take medications that affect body weight or would interfere with time-restricted eating. If you're on such medications, you may need to stop them to participate.

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

Research has shown that time-restricted eating (TRE) is generally safe for participants. In studies involving people with obesity, TRE resulted in a weight loss of about 3%–5% over 2–12 months. These studies not only assess TRE's effectiveness but also indicate it is well-tolerated without major safety issues.

Moreover, other studies have found improvements in health markers, such as insulin levels, without significant negative effects. This suggests that TRE does not cause serious side effects for most people.

Overall, current evidence suggests that TRE is a safe option for managing weight. However, individual experiences may differ, so consulting a healthcare provider about any concerns is advisable. ^{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 diets. TRE involves limiting eating to a specific window of time each day—typically 10 hours or less—without strictly focusing on what or how much you're eating. This method may help regulate metabolism and improve overall health by aligning eating patterns with the body's natural circadian rhythms. Unlike typical diets that can be hard to stick to, TRE might be easier to maintain, making it an appealing option for long-term weight management.

What evidence suggests that time-restricted eating is effective for weight loss maintenance?

This trial will compare Time-Restricted Eating (TRE) with a Baseline Advice Control (CON) for weight loss maintenance. Research has shown that TRE can aid in weight loss and body fat reduction. For individuals with obesity, TRE has resulted in a 3%–5% weight loss over 2 to 12 months compared to those not using TRE. Some studies suggest that eating earlier in the day with TRE is more effective for losing weight and fat. However, not everyone experiences weight loss with TRE, especially if they consume the same or more calories than before. Overall, TRE might help maintain recent weight loss, but results can vary from person to person. ^{1 2 4 6 7}

Who Is on the Research Team?

Collin Popp

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

Adults aged 25-65 who've lost at least 5% of their weight in the past 3 months, have a BMI between 20.5 and 45, and can use a smartphone for self-monitoring are eligible. Those pregnant, breastfeeding, with eating disorders, on weight-affecting meds or doing shift work more than once weekly cannot join.

Inclusion Criteria

For in-person screening, eligible participants will provide signed informed consent and have their temporal eating patterns measured

Current BMI 20.5-45 mg/kg2

I have lost more than 5% of my weight without trying in the last 3 months.

Exclusion Criteria

Unable to log at least 2 meals into the smartphone app for 70% (~20 days) during the run-in period

Pregnant, trying to get pregnant, or breastfeeding

>2.5 kg additional weight loss during the run-in phase (weight regain is not an exclusion criteria)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Run-in

4-week run-in period to establish weight stabilization and measure eating patterns before randomization

4 weeks

Treatment

Participants are randomized to either the TRE intervention or the CON group, with measurements at baseline, 6 months, and 12 months

12 months

3 visits (in-person) at baseline, 6 months, and 12 months

Follow-up

Participants are monitored for weight and fat mass changes using DEXA scans and subjective appetite changes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TRE

Trial Overview The TWIST 2.0 Study is testing if Time Restricted Eating (TRE) helps adults maintain their recent weight loss over a year compared to just getting weight-loss maintenance advice. It's a randomized controlled trial looking at changes in body fat and appetite after meals.

How Is the Trial Designed?

Group I: Time-Restricted Eating (TRE) Experimental Treatment 1 Intervention

Participants assigned to the intervention: ≤10-hour/day time restricted eating.

Group II: Baseline Advice Control (CON) Active Control 1 Intervention

Participants assigned to receive baseline advice.

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/PMC12479299/

Effects of time-restricted eating on body composition and ... Our findings indicate that TRE significantly improves insulin levels in overweight and obese women, whereas no significant alterations were ...

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

Time-restricted eating: Watching the clock to treat obesity In participants with obesity, time-restricted eating results in 3%–5% weight loss over 2–12 months, versus controls. Reductions in body weight ...

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

Effectiveness of Early Time-Restricted Eating for Weight ... In a secondary analysis of completers, early time-restricted eating was more effective for losing weight and body fat. Meaning Early time- ...

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

Calorie Restriction with or without Time-Restricted Eating ... In this 12-month trial, we found that the 8-hour time-restricted–eating regimen did not produce greater weight loss than the regimen of daily ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9165551/

Time-Restricted Feeding Studies and Possible Human Benefit TRE does not lead to weight loss among all individuals, especially if the individual is able to consume as many or more calories than they did prior to ...

6. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2771095

Effects of Time-Restricted Eating on Weight Loss and Other ... This randomized clinical trial examines the effect of 16:8-hour time-restricted eating on weight loss and metabolic risk markers.

7. 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 ...