Time Restricted Eating for Weight Management

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must not be taking: Weight loss, Glucose-lowering

Disqualifiers: Diabetes, Eating disorders, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different eating patterns might aid weight management for adults with obesity. Participants will be divided into three groups: one will eat freely during an 8-hour window each day (time-restricted eating), another will follow a calorie-restricted diet, and a third will maintain their usual eating habits. The goal is to determine which approach is most effective for losing weight and maintaining the loss over a year. The trial seeks adults who have been obese and mostly inactive for the last three months. As an unphased trial, it offers participants the chance to contribute to valuable research that could shape future weight management strategies.

Will I have to stop taking my current medications?

The trial requires that you stop taking medications that affect weight loss or blood sugar levels, as these could influence the study's outcomes.

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

Research has shown that eating only during an 8-hour window each day, known as time-restricted eating (TRE), can aid in weight loss. However, some safety concerns exist. One study found a higher risk of heart-related deaths among people following this eating pattern. These results are not yet fully understood, and further research is needed.

Conversely, eating fewer calories each day, known as calorie restriction (CR), has been studied more thoroughly. Research indicates that it is generally safe and can aid in weight loss and health improvement without causing eating disorders or mood issues. In short-term studies, participants managed calorie restriction well and did not report major side effects.

Both 8-hour TRE and CR are generally considered safe, but consulting a healthcare professional is important, especially for those with existing health conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores innovative dietary strategies for weight management that differ from traditional methods like medication or surgery. The 8-hour time-restricted eating approach allows individuals to eat freely from noon to 8 p.m., potentially making it easier to follow than calorie counting or meal planning. Meanwhile, the calorie restriction method focuses on reducing daily energy intake by 25%, which could provide a structured yet flexible alternative to more extreme dieting methods. By examining these strategies, researchers hope to uncover effective and sustainable ways to manage weight, improving overall health outcomes.

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

This trial will compare 8-hour time-restricted eating (TRE) and calorie restriction (CR) for weight management. Studies have shown that both TRE and CR aid in weight loss. Research indicates that TRE can result in a 3% to 5% reduction in body weight over a few months. One study found that adults with type 2 diabetes lost more weight with TRE than with CR. For calorie restriction, various studies have reported effective weight loss, although some weight may be regained over time. Overall, both methods have shown promise in helping people lose weight. ^{1 2 3 5 6}

Who Is on the Research Team?

Krista Varady, PhD

Principal Investigator

University of Illinois Chicago

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with obesity (BMI of 30-50) who are sedentary or lightly active. It's not suitable for those unstable in weight, on certain medications, unable to maintain a food/activity log, with eating disorders, irregular menstrual cycles, smokers, diabetics, night shift workers, or pregnant individuals.

Inclusion Criteria

I am mostly inactive or lightly active.

You haven't been doing much physical activity in the past 3 months, like walking or light exercise, for less than an hour per week.

My BMI is between 30 and 50.

Exclusion Criteria

Your weight has changed by more than 4 kilograms in the past 3 months.

I am not on medications that affect weight or blood sugar.

Pregnant, or trying to become pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Weight Loss

Participants undergo a 6-month weight loss period with different dietary interventions: 8h-TRE, CR, or control

6 months

Monthly visits (in-person)

Weight Maintenance

Participants continue with their assigned dietary interventions to maintain weight loss over 6 months

6 months

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the weight maintenance phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 8-hour Time restricted eating
• Calorie restriction

Trial Overview The study tests if eating within an 8-hour window (12pm-8pm) leads to better weight management compared to daily calorie restriction or no intervention over a year. Participants will first focus on losing weight for six months and then maintaining it for another six.

How Is the Trial Designed?

Group I: Calorie restriction Experimental Treatment 1 Intervention

25% energy restriction every day

Group II: 8-hour Time restricted eating Experimental Treatment 1 Intervention

Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)

Group III: Control Active Control 1 Intervention

Usual diet, Ad libitum intake, eating within \>10 hours per day

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Citations

1. nia.nih.gov nia.nih.gov/news/timeframe-8-hour-restricted-eating-irrelevant-weight-loss

Timeframe of 8-hour restricted eating irrelevant to weight loss The results showed all three time-restricted eating groups achieved more weight loss — averages of 5.3 pounds, 6.4 pounds, and 6.8 pounds ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35939311/

Effectiveness of Early Time-Restricted Eating for Weight Loss ... 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. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2811116

Effect of Time-Restricted Eating on Weight Loss in Adults ... In a 6-month randomized clinical trial involving 75 adults with T2D, TRE was more effective for weight loss (−3.6%) than CR (−1.8%) compared with controls.

4. newsroom.heart.org newsroom.heart.org/news/8-hour-time-restricted-eating-linked-to-a-91-higher-risk-of-cardiovascular-death

8-hour time-restricted eating linked to a 91% higher risk of ... 8-hour time-restricted eating linked to a 91% higher risk of cardiovascular death · The study included approximately 20,000 adults in the U.S. ...

5. 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 ...

6. 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 ...