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

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

A 12-month randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1) 6-month weight loss period; and (2) 6-month weight maintenance, will be implemented. Adults with obesity will be randomized to 1 of 3 groups: (1) 8h-TRE, ad libitum food intake from 12pm to 8 pm, fasting from 8 pm to 12 pm daily, (2) CR, 25% energy restriction every day; or 3) control, ad libitum food intake daily, eating within more than 10 hours per day.

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+